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<strong>2008</strong> <strong>National</strong><br />

<strong>Immunisation</strong> <strong>Schedule</strong><br />

<strong>Health</strong> <strong>Provider</strong> Booklet


Published in May <strong>2008</strong> by the<br />

Ministry of <strong>Health</strong><br />

PO Box 5013, Wellington, New Zealand<br />

ISBN 978-0-478-31748-0 (print)<br />

ISBN 978-0-478-31749 (online)<br />

HP 4575<br />

This document is available on the Ministry of <strong>Health</strong>’s website:<br />

http://www.moh.govt.nz


Contents<br />

Introduction 1<br />

Informed consent 1<br />

Eligibility for schedule vaccines 1<br />

1 <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> 2<br />

1.1 <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> 2<br />

1.2 Changes to the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> 2<br />

1.3 Other schedule vaccines – Td, Hepatitis B, BCG 3<br />

1.4 Ordering <strong>2008</strong> <strong>Schedule</strong> vaccines 4<br />

1.5 How to claim the immunisation benefit – <strong>Health</strong>PAC Information 4<br />

1.6 What to do with unused 2006 schedule vaccines 4<br />

1.7 <strong>Health</strong> education resources 5<br />

1.8 NIR forms 5<br />

1.9 Who to contact if you have questions 5<br />

2 Key Points 6<br />

2.1 dTap (Boostrix TM ) vaccine 6<br />

2.2 DTaP-IPV-HepB/Hib (Infanrix®-hexa) vaccine 7<br />

2.3 PCV7 (Prevenar®) vaccine 10<br />

2.4 MeNZB TM vaccine 13<br />

2.5 Expansion of the high risk pneumococcal programme for children under five years of<br />

age with a chronic condition 16<br />

2.6 HPV immunisation programme 18<br />

2.7 New schedule vaccine presentation and administration 21<br />

3 dTap (Boostrix) Vaccine and Pertussis Epidemiology 23<br />

3.1 dTap (Boostrix TM ) vaccine schedule 23<br />

3.2 Rationale for introducing the dTap vaccine 23<br />

3.3 Pertussis epidemiology 23<br />

3.4 dTap (Boostrix TM ) vaccine information 25<br />

3.5 Other recommendations 27<br />

3.6 <strong>National</strong> <strong>Immunisation</strong> Register and School Based Vaccination System 28<br />

4 DTaP-IPV-HepB/Hib (INFANRIX ® -hexa) 29<br />

4.1 Early introduction of DTaP-IPV-HepB/Hib from March <strong>2008</strong> 29<br />

4.2 DTaP-IPV-HepB/Hib vaccine schedule – from 1 June <strong>2008</strong> 29<br />

4.3 Change in type of Hib vaccine 29<br />

4.4 DTaP-IPV-HepB/Hib vaccine information 29<br />

4.5 DTaP-IPV-HepB/Hib vaccine and the <strong>National</strong> <strong>Immunisation</strong> Register 33<br />

4.6 DTaP-IPV-HepB/Hib vaccine and claiming the immunisation benefit 33<br />

5 Pneumococcal Conjugate Vaccine (PCV7, Prevenar ® ) and<br />

Pneumococcal Epidemiology 34<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet iii


5.1 PCV7 vaccine schedule – from 1 June <strong>2008</strong> 34<br />

5.2 Pneumococcal disease 34<br />

5.3 Epidemiology 36<br />

5.4 Effects of introducing pneumococcal vaccine onto the infant immunisation programme 39<br />

5.5 Immunogenicity and efficacy of pneumococcal conjugate vaccine 45<br />

5.6 PCV7 vaccine information 46<br />

5.7 PCV7 vaccine and the <strong>National</strong> <strong>Immunisation</strong> Register – <strong>National</strong> <strong>Immunisation</strong><br />

<strong>Schedule</strong> only 48<br />

5.8 PCV7 vaccine and claiming the immunisation benefit – Childhood <strong>Immunisation</strong><br />

<strong>Schedule</strong> only 48<br />

6 Expansion of the High Risk Pneumococcal Programme for<br />

Children under Five Years of Age with a Chronic Condition 49<br />

6.1 Addition of new eligible groups 49<br />

6.2 High risk pneumococcal programme immunisation schedule 49<br />

6.3 Entering high-risk pneumococcal programme vaccines on the <strong>National</strong> <strong>Immunisation</strong><br />

Register 50<br />

6.4 Claiming for high-risk pneumococcal programme vaccines 51<br />

Appendix 1: <strong>Immunisation</strong> Catch-up <strong>Schedule</strong>s 52<br />

1.1 <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> catch-up schedules 52<br />

1.2 High risk pneumococcal immunisation programme catch-up schedules 55<br />

Appendix 2: Pre/Post Splenectomy <strong>Immunisation</strong> Programme 56<br />

References 58<br />

List of Tables<br />

Table 1.1: <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> from 1 June <strong>2008</strong> 2<br />

Table 2.1: PCV7 vaccine catch-up programme 10<br />

Table 2.2: Eligibility criteria for high-risk pneumococcal programme 16<br />

Table 5.1: PCV7 vaccine schedule 34<br />

Table 6.1: Eligibility criteria for high-risk pneumococcal programme 49<br />

Table 6.2:<br />

<strong>Schedule</strong> for pneumococcal vaccines for children at higher risk of pneumococcal<br />

disease with no prior history of pneumococcal vaccines 50<br />

List of Figures<br />

Figure 3.1: Notifications of pertussis in New Zealand (all ages), 2001–2007 24<br />

Figure 3.2: Age-specific rates of pertussis in New Zealand 2000–2006 24<br />

Figure 5.1: Pneumococcal disease spectrum (for use as a guide only) 35<br />

Figure 5.2: Hospitalisations from pneumococcal meningitis in children under two years of age,<br />

1999–2006 37<br />

Figure 5.3: Hospitalisations from pneumococcal septicaemia in children under two years of age,<br />

1999–2006 38<br />

Figure 5.4: Rate of vaccine-type (VT) invasive pneumococcal disease (IPD) before and after<br />

introduction of pneumococcal conjugate vaccine (PCV7), by age group and year;<br />

Active Bacterial Core surveillance, United States, 1998–2003 40<br />

iv<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


Introduction<br />

This <strong>booklet</strong> includes the following information about the <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong><br />

<strong>Schedule</strong> (<strong>Schedule</strong>):<br />

• changes to the <strong>Schedule</strong> in <strong>2008</strong><br />

• new vaccines (rationale for introduction, vaccine schedules, efficacy, safety)<br />

• information on stopping the MeNZB vaccine special programme (see Key Points)<br />

• children starting on or changing to the <strong>2008</strong> <strong>Schedule</strong> (Catch-up <strong>Schedule</strong>s)<br />

• key points information on the HPV (human papillomavirus) <strong>Immunisation</strong> Programme<br />

• vaccine ordering information<br />

• <strong>National</strong> <strong>Immunisation</strong> Register updates<br />

• immunisation benefit claims<br />

• what to do with unused 2006 schedule vaccines<br />

• an update on immunisation resources available for providers and parents<br />

• who to contact if you have questions.<br />

Informed consent<br />

The Ministry of <strong>Health</strong> recommends immunisation however it is a parent’s choice to<br />

immunise their child. For more information on informed consent refer to the<br />

<strong>Immunisation</strong> Handbook 2006.<br />

Eligibility for schedule vaccines<br />

Children under 16 years of age<br />

All children under 16 years of age are eligible for free <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong><br />

vaccines (http://www.moh.govt.nz/moh.nsf/indexmh/eligibility-healthservices-doctor).<br />

Unimmunised adults<br />

Unimmunised adults 16 years and over are eligible for free primary courses of the<br />

following vaccines:<br />

• Td (three doses)<br />

• MMR (two doses)<br />

• IPV (three doses)<br />

• Hepatitis B (three doses – household and sexual contacts of hepatitis B carriers<br />

only).<br />

The immunisation benefit may be claimed for these vaccines.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 1


1 <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong><br />

1.1 <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong><br />

Table 1.1: <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> from 1 June <strong>2008</strong><br />

<strong>Immunisation</strong> given<br />

Brand name<br />

DTaP-IPV-<br />

HepB/Hib<br />

Infanrix®-<br />

Hexa<br />

PCV7 Hib MMR DTaP-IPV dTap* HPV**<br />

Prevenar® Hiberix M-M-R® II Infanrix-IPV Boostrix Gardasil®<br />

Manufacturer GSK Wyeth GSK MSD GSK GSK CSL<br />

6 weeks • •<br />

3 months • •<br />

5 months • •<br />

15 months • • •<br />

4 years • •<br />

11 years •<br />

12 years<br />

girls only<br />

* From 1 January dTap is given to 11-year-old children.<br />

** From 2009<br />

Vaccine key<br />

D = diphtheria; T = tetanus; aP = acellular pertussis; HepB = hepatitis B; IPV = inactivated polio vaccine;<br />

Hib = Haemophilus influenzae type b; PCV7 = 7-valent pneumococcal conjugate vaccine;<br />

MMR = measles-mumps-rubella; d = adult dose diphtheria; ap = adult dose acellular pertussis, HPV =<br />

human papillomavirus.<br />

• 3 doses<br />

1.2 Changes to the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong><br />

From January <strong>2008</strong><br />

• dTap (Boostrix TM ) vaccine is given at age 11 years instead of dTap-IPV.<br />

From March <strong>2008</strong><br />

• Introduction of DTaP-IPV-HepB/Hib (Infanrix®-hexa) vaccine instead of DTaP-IPV<br />

(Infanrix-IPV) and Hib-HepB (Comvax®) at age six weeks and three and five<br />

months.<br />

2 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


From 1 June <strong>2008</strong><br />

• Introduction of pneumococcal conjugate (PCV7, Prevenar®) vaccine for all babies<br />

born from 1 January <strong>2008</strong>.<br />

• Introduction of DTaP-IPV-HepB/Hib (Infanrix®-hexa) vaccine for all babies.<br />

• Cessation of meningococcal B (MeNZB TM ) vaccine special programme.<br />

• Expansion of high-risk pneumococcal programme for children under five years of<br />

age.<br />

From 1 September <strong>2008</strong><br />

• Introduction of the human papillomavirus (HPV) vaccine for young women aged<br />

17 and 18 years (i.e. born in 1990 and 1991).<br />

From early 2009<br />

• Introduction of the HPV vaccine onto the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> for 12 year<br />

old girls (in primary care and health clinics) and girls in school Year 8.<br />

• HPV vaccine given to girls aged 13 to 18 years. Delivery of HPV vaccine to these<br />

cohorts will be phased over 2009 and 2010.<br />

For further information about the new vaccines refer to the section 2 Key Points and<br />

sections 3 to 6.<br />

1.3 Other schedule vaccines – Td, Hepatitis B, BCG<br />

There are no changes in the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> for the Td, Hepatitis B,<br />

and BCG vaccines.<br />

Practitioners are reminded that all pregnant women should be assessed for:<br />

• their hepatitis B status (HBsAg or HBeAg positive) in early pregnancy<br />

• the risk of tuberculosis for their baby.<br />

Neonatal BCG should be offered to newborns at increased risk for tuberculosis, see the<br />

<strong>Immunisation</strong> Handbook 2006, chapter 12, page 248 (Ministry of <strong>Health</strong> 2006).<br />

Please ensure that all babies of mothers who are HBsAg or HBeAg positive receive:<br />

• hepatitis B vaccine and hepatitis B immunoglobulin at birth; and<br />

• doses of hepatitis B vaccine at six weeks and three and five months.<br />

The baby’s serology must be checked at age five months, at the time of the fourth dose, to<br />

check for immunity/infection. See the <strong>Immunisation</strong> Handbook 2006, Figure 3.3,<br />

page 134 for details (Ministry of <strong>Health</strong> 2006).<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 3


1.4 Ordering <strong>2008</strong> <strong>Schedule</strong> vaccines<br />

All schedule vaccines can be ordered by fax through ProPharma:<br />

• dTap (Boostrix) is available to order<br />

• DTaP-IPV-HepB/Hib (Infanrix®-hexa) is available to order<br />

• PCV7 (Prevenar®) is available to order.<br />

• While no longer recommended for routine use, the MeNZB vaccine can continue to<br />

be accessed from ProPharma (See Sections 2 and 6 for more information on the use<br />

of the MeNZB vaccine) from 1 June <strong>2008</strong>.<br />

• HPV (GARDASIL®) can be ordered by primary care providers from August <strong>2008</strong> and<br />

will be available for school immunisation programmes to order in early 2009.<br />

Please ring ProPharma on 0800 400 101 if you:<br />

• do not have a ProPharma account<br />

• need a fax order form.<br />

1.5 How to claim the immunisation benefit – <strong>Health</strong>PAC Information<br />

See Section 2 Key Points and Sections 3-7 for more detailed information on claiming for<br />

specific vaccines.<br />

For information about claiming from <strong>Health</strong>PAC and error codes and their meanings,<br />

please refer to the Ministry’s Frequently Asked Questions webpage at:<br />

http://www.moh.govt.nz/moh.nsf/indexmh/healthpac-faq-immunisation<br />

For <strong>Health</strong>PAC claim forms, please phone Wickliffe Press on 0800 259 138 and quote<br />

your payee number.<br />

1.6 What to do with unused 2006 schedule vaccines<br />

Hib-HepB vaccine – COMVAX ®<br />

From 1 June <strong>2008</strong>, all unused stock of Hib-HepB vaccine (Comvax®) should be<br />

returned to ProPharma.<br />

Hepatitis B vaccine – HBvaxPRO ®<br />

The hepatitis B vaccine (HBvaxPRO) doses for children should be retained if the<br />

practice is likely to use these vaccines before the expiry date.<br />

Note that the birth dose of hepatitis B is given to those babies born to mothers who<br />

carry the hepatitis B virus (see section 8).<br />

DTaP-IPV – INFANRIX TM -IPV<br />

DTaP-IPV vaccine (Infanrix®-IPV) will continue to be used for the immunisation event at<br />

age four years.<br />

4 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


1.7 <strong>Health</strong> education resources<br />

The Ministry of <strong>Health</strong> immunisation resources will be updated to include all the <strong>2008</strong><br />

changes to the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>. These updated resources can be<br />

ordered through the <strong>Health</strong>Ed website: http://www.healthed.govt.nz.<br />

A new resource has been developed to provide parents and caregivers with further<br />

information on the pneumococcal vaccine (PCV7, Prevenar®). This resource can be<br />

ordered through the <strong>Health</strong>Ed website: http://www.healthed.govt.nz.<br />

1.8 NIR forms<br />

NIR forms are being updated for the <strong>2008</strong> <strong>Schedule</strong> effective from 1 June <strong>2008</strong>.<br />

To reorder NIR forms:<br />

• Phone: (04) 496 2277<br />

• Email: moh@wickliffe.co.nz<br />

• Fax: 0800 802 126.<br />

Please quote the reference number printed on the form with any order made.<br />

1.9 Who to contact if you have questions<br />

Vaccine ordering<br />

<strong>Immunisation</strong> benefit claiming<br />

Reordering NIR forms<br />

Technical Advice<br />

<strong>National</strong> <strong>Immunisation</strong><br />

Programme<br />

Propharma<br />

0800 400 101<br />

<strong>Health</strong>PAC<br />

0800 458 448<br />

www.moh.govt.nz/moh.nsf/indexmh/healthpac-faq-immunisation<br />

moh@wickliffe.co.nz<br />

Fax 0800 802 126<br />

<strong>Immunisation</strong> Advisory Centre (IMAC)<br />

0800 IMMUNE or 0800 466 863<br />

www.immune.org.nz<br />

• <strong>National</strong> <strong>Immunisation</strong> Programme queries:<br />

immunisation@moh.govt.nz<br />

• General immunisation information/ <strong>Immunisation</strong> Handbook 2006:<br />

www.moh.govt.nz/immunisation<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 5


2 Key Points<br />

2.1 dTap (Boostrix TM ) vaccine<br />

For further detailed information about the adult diphtheria, tetanus, adult acellular<br />

pertussis (dTap, Boostrix TM ) vaccine, see section 3 and the Boostrix TM data sheet (refer<br />

to the Medsafe data sheets at:<br />

http://www.medsafe.govt.nz/profs/Datasheet/dsform.asp).<br />

Note: The dTap vaccine is delivered as a school-based (year 7) immunisation<br />

programme in the North Island and Nelson Marlborough DHBs and by primary health<br />

care services in the remainder of the South Island.<br />

Why was dTap introduced<br />

From 1 January <strong>2008</strong>, the dTap (Boostrix TM ) vaccine replaced the dTap-IPV (Boostrix®-<br />

IPV) vaccine on the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> at 11 years of age. From <strong>2008</strong>, all<br />

11-year-old children will have already received the recommended four doses of polio<br />

vaccine in childhood.<br />

Will dTap vaccine be recorded on the <strong>National</strong> <strong>Immunisation</strong> Register<br />

In primary health care situations, dTap vaccine will not be recorded on the <strong>National</strong><br />

<strong>Immunisation</strong> Register (NIR) as 11-year-old students are not in the NIR’s birth cohort.<br />

The School Based Vaccination System (SBVS) has been updated for the introduction of<br />

the dTap vaccine. The SBVS will not provide details of dTap vaccine events to the NIR.<br />

Why should dTap vaccine be delayed until two years after receipt of a tetanusdiphtheria<br />

vaccine (eg, Td vaccine after an injury)<br />

This delay in administering dTap aims to decrease the risk and severity of a local<br />

reaction at the injection site. This precaution may be waived if a pertussis epidemic is<br />

beginning and the student lives in a household with an unimmunised younger sibling or<br />

a pregnant woman.<br />

Students who have received Td vaccinations in the past two years should be referred to<br />

their general practitioner for follow-up and recall. The dTap vaccine should be offered<br />

to these students before they reach 16 years of age.<br />

If the child received a Td vaccine booster three to five years ago, dTap immunisation is<br />

recommended.<br />

6 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


2.2 DTaP-IPV-HepB/Hib (Infanrix®-hexa) vaccine<br />

For further detailed information about Infanrix®-hexa, see section 4, and the Infanrix®hexa<br />

data sheet (refer to the Medsafe data sheets at:<br />

http://www.medsafe.govt.nz/profs/Datasheet/dsform.asp).<br />

Why was DTaP-IPV-HepB/Hib (Infanrix®-hexa) introduced in mid-March <strong>2008</strong><br />

Due to Hib-HepB (Comvax®) vaccine manufacturing problems, New Zealand was not<br />

able to secure further supplies of Comvax® vaccine beyond March <strong>2008</strong>. Stocks of<br />

Comvax® vaccine have run out, and DTaP-IPV-HepB/Hib (Infanrix®-hexa) vaccine is<br />

now available.<br />

Please continue to use your practice’s supply of Comvax® vaccine until it has run out.<br />

Who is eligible for the DTaP-IPV-HepB/Hib (Infanrix®-hexa) vaccine<br />

All babies due for their six-week, three-month or five-month immunisations are eligible<br />

for the Infanrix®-hexa vaccine.<br />

The Ministry of <strong>Health</strong> recommends Infanrix®-hexa also be given to children at five<br />

months of age, replacing DTaP-IPV and HepB (HBvaxPRO). However DTaP-IPV and<br />

HepB vaccines may still be given to five-month-old babies until 1 June <strong>2008</strong>.<br />

A change of vaccine within a primary series is safe and expected to be effective.<br />

The introduction of Infanrix®-hexa vaccine means there will be two injections given at<br />

six weeks and three and five months of age (Prevenar® and Infanrix®-hexa).<br />

How is DTaP-IPV-HepB/Hib (Infanrix®-hexa) administered<br />

Infanrix®-hexa vaccine is administered by intramuscular injection into the thigh.<br />

Note: The Infanrix®-hexa and Prevenar® vaccines should be given in separate limbs<br />

Infanrix®-hexa vaccine must be reconstituted prior to administration as follows.<br />

• Attach the 25-gauge needle to the pre-filled syringe.<br />

• Transfer the syringe’s liquid suspension to the vial containing the Hib pellet.<br />

• Shake the vial well to ensure the Hib pellet is completely dissolved.<br />

• Draw the reconstituted vaccine back into the syringe.<br />

• Attach the 23-gauge needle to the syringe for vaccine administration.<br />

• After reconstitution, the vaccine should be injected promptly.<br />

• However, the vaccine may be kept for up to eight hours at room temperature (21°C).<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 7


DTaP-IPV-HepB/Hib (Infanrix®-hexa) and PCV7 (Prevenar®) – fever management<br />

A higher incidence of fever (> 39.5°C) was reported in infants receiving Infanrix®-hexa<br />

and Prevenar® compared to infants receiving Infanrix®-hexa vaccine alone. (See<br />

section 4.4 for more information.)<br />

How to manage fever<br />

• Give the baby extra fluids to drink (more breastfeeds or water).<br />

• Do not overdress the baby if hot.<br />

• Paracetamol may be given for pain relief before immunisation.<br />

The Hib component of DTaP-IPV-HepB/Hib (Infanrix®-hexa) is different to that of<br />

the Hib-HepB (Comvax®) vaccine. What does this mean for disease protection<br />

The Haemophilus influenzae type b (Hib) component of the Hib-HepB vaccine was<br />

previously used as a schedule vaccine because it offers protection after a single dose –<br />

as early as six weeks of age. The Hib component of the Infanrix®-hexa vaccine does<br />

not offer this early protection.<br />

There is a small risk that Hib disease will re-emerge with this change. However, the<br />

incidence of Hib disease in New Zealand has significantly declined since Hib vaccine<br />

was introduced in 1994, with five to 10 cases occurring every year in unimmunised<br />

children.<br />

Following the vaccine change, Hib disease will be monitored using the existing<br />

surveillance systems.<br />

Can alternatives to DTaP-IPV-HepB/Hib (Infanrix®-hexa) vaccine be given<br />

When a child has a genuine contraindication to a component of the Infanrix®-hexa<br />

vaccine, alternative vaccines may be given (if available) and the immunisation benefit<br />

claimed.<br />

How do I enter DTaP-IPV-HepB/Hib (Infanrix®-hexa) onto the <strong>National</strong><br />

<strong>Immunisation</strong> Register<br />

PMS and NIR upgrades for Infanrix®-hexa are expected from 1 June <strong>2008</strong>.<br />

Before 1 June <strong>2008</strong>, enter Infanrix®-hexa into the Patient Management System (PMS)<br />

as two separate vaccines (two events). Therefore:<br />

• enter Hib-HepB (or HepB) and then enter DTaP-IPV as separate events (as you<br />

currently do with the 2006 <strong>National</strong> Childhood <strong>Immunisation</strong> <strong>Schedule</strong>)<br />

• enter the same Infanrix®-hexa batch number and expiry date into both events’ batch<br />

number and expiry field.<br />

Note: Prior to 1 June <strong>2008</strong>, this will be recorded in your PMS and the NIR as if two<br />

separate vaccinations were given.<br />

8 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


From 1 June <strong>2008</strong>, the NIR will record the Infanrix®-hexa vaccine events as part of the<br />

<strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>.<br />

How do I claim the immunisation benefit for Infanrix®-hexa vaccinations given<br />

<strong>Health</strong>PAC payment systems will not be updated for Infanrix®-hexa until 1 June <strong>2008</strong>.<br />

Before 1 June <strong>2008</strong>, for the six-week, three and five-months events claim as though<br />

DTaP-IPV and Hib-HepB or HepB vaccines were given, that is, record the DTaP-IPV-<br />

HepB/Hib (Infanrix®-hexa) vaccination event as if two separate vaccinations were<br />

given.<br />

From 1 June <strong>2008</strong>, <strong>Health</strong>PAC payment systems will accept claims for the DTaP-IPV-<br />

HepB/Hib (Infanrix®-hexa) vaccine.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 9


2.3 PCV7 (Prevenar®) vaccine<br />

For further detailed information about PCV7 (Prevenar®) and pneumococcal disease,<br />

see section 5 and the Prevenar® data sheet (refer to the Medsafe data sheets at:<br />

http://www.medsafe.govt.nz/profs/Datasheet/dsform.asp).<br />

Why is the PCV7 vaccine being added to the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong><br />

from 1 June <strong>2008</strong><br />

PCV7 vaccine protects young children against the seven most common strains of the<br />

Streptococcus pneumoniae bacteria that cause severe pneumococcal disease. Severe<br />

pneumococcal disease can cause meningitis, blood poisoning and pneumonia. All<br />

babies are at risk of severe pneumococcal disease.<br />

The pneumococcus is the most common bacterial cause of otitis media in children and<br />

a frequent cause of sinusitis and pneumonia in all age groups.<br />

Who is eligible for the PCV7 vaccine<br />

All babies born from 1 January <strong>2008</strong> will be eligible to receive PCV7 vaccine from<br />

1 June <strong>2008</strong>.<br />

What is the PCV7 vaccine schedule<br />

From 1 June <strong>2008</strong>, all new babies beginning their childhood immunisations will be<br />

offered the PCV7 vaccine. These babies will receive four doses of the PCV7 vaccine at<br />

the same time as other <strong>Schedule</strong> vaccines at age six weeks and three, five and<br />

15 months of age (see the <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> table in section 1).<br />

Babies born from 1 January <strong>2008</strong> will receive a catch-up schedule for PCV7 vaccine.<br />

What is the catch-up programme for PCV7 vaccine<br />

A catch-up programme is available for babies born from 1 January <strong>2008</strong>. These<br />

children can receive PCV7 vaccine from 1 June <strong>2008</strong>. (See the PCV7 vaccine schedule<br />

below for the number of doses required for the age of the baby at catch up.)<br />

Table 2.1: PCV7 vaccine catch-up programme<br />

Age of baby at PCV7 dose 1<br />

PCV7 vaccine schedule<br />

6 weeks to 6 months 6 weeks, 3 months, 5 months, 15 months of age OR<br />

3 doses 6 to 8 weeks apart + 1 dose at age 15 months<br />

7 months to 11 months of age* 2 doses 6 weeks apart + 1 dose at age 15 months<br />

12 to 23 months* 2 doses of PCV7 given 6 to 8 weeks apart<br />

* Applies only to babies born from 1 January <strong>2008</strong>.<br />

This catch-up programme is in place because children aged under one year are at<br />

greatest risk of severe pneumococcal disease.<br />

10 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


PCV7 (Prevenar®) and DTaP-IPV-HepB/Hib (Infanrix®-hexa) – fever management<br />

A higher incidence of fever (> 39.5°C) was reported in infants receiving Infanrix®-hexa<br />

and Prevenar® compared to infants receiving Infanrix®-hexa vaccine alone (see section<br />

4.4 for more information).<br />

How to manage fever<br />

• Give the baby extra fluids to drink (more breastfeeds or water).<br />

• Do not overdress the baby if hot.<br />

• Paracetamol may be given for pain relief before immunisation.<br />

Avoid giving PCV7 (Prevenar®) at the same visit as MeNZB vaccine<br />

While no problems are anticipated, either in the immune response or safety, there is no<br />

data to support giving the MeNZB TM vaccine at the same practice visit as Prevenar®.<br />

Therefore, where parents are anxious for their child to receive the MeNZB vaccine<br />

and the doctor agrees, a three-dose course of the MeNZB vaccine could start at six<br />

months of age (doses six weeks apart).<br />

See section 2.4 for more information on the eligibility for the MeNZB vaccine from<br />

1 June <strong>2008</strong>.<br />

How do I enter the PCV7 vaccine on the <strong>National</strong> <strong>Immunisation</strong> Register<br />

From 1 June <strong>2008</strong>, the NIR will record PCV7 vaccine events as part of the <strong>National</strong><br />

<strong>Immunisation</strong> <strong>Schedule</strong> for:<br />

• new babies beginning their immunisations<br />

• babies born from 1 January <strong>2008</strong> on a catch-up schedule.<br />

Note: The above information does not apply to children receiving PCV7 vaccine as part<br />

of the high-risk pneumococcal or pre/post-splenectomy programmes (see section 6 and<br />

Appendix 2). Information for the high risk pneumococcal or pre/post splenectomy<br />

programmes is recorded on the NIR as the ‘Pneumococcal’ programme.<br />

How do I claim the immunisation benefit for the PCV7 vaccine<br />

From 1 June <strong>2008</strong>, immunisation benefit claims for the PCV7 vaccine will be valid if<br />

administered from 1 June <strong>2008</strong>. Note: Any immunisation benefit claims for PCV7<br />

vaccine administered as a schedule vaccine before 1 June <strong>2008</strong> will be rejected.<br />

Note: <strong>Immunisation</strong> benefit claims for the PCV7 vaccine as a schedule vaccine are valid<br />

for babies with a birth date from 1 January <strong>2008</strong>. <strong>Immunisation</strong> benefit claims for the<br />

PCV7 <strong>Schedule</strong> vaccine will be rejected if the vaccine has been administered to babies<br />

with a birth date before 1 January <strong>2008</strong>.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 11


How is PCV7 vaccine expected to benefit New Zealand<br />

The introduction of PCV7 vaccine to the infant immunisation schedule in the United<br />

States has resulted in a decline in severe pneumococcal disease incidence in young<br />

children and a decline in invasive pneumococcal disease (IPD) in unimmunised adults.<br />

In New Zealand in 2006, there were 151 children aged under five years of age with IPD.<br />

By comparing the pneumococcal strains that caused their disease against the seven<br />

strains in the pneumococcal vaccine, ESR predicted that 83% of pneumococcal disease<br />

in children under five years could have been prevented by using the pneumococcal<br />

vaccine.<br />

Is invasive pneumococcal disease notifiable<br />

It is planned that IPD will be added to the list of infectious diseases to be notified by<br />

medical practitioners and by laboratories before the vaccine programme starts in<br />

June <strong>2008</strong>.<br />

Will there be pneumococcal serotype replacement following the introduction of<br />

PCV7 vaccine<br />

In the United States, surveillance results suggest some serotype replacement had<br />

occurred in the three years after the introduction of PCV7 vaccine to infants. However,<br />

the burden of IPD in young children remained lower than in the years before the<br />

introduction of Prevenar®. See section 5.4.<br />

Therefore, ongoing surveillance of IPD in New Zealand will be important to monitor for<br />

any serotype replacement. Longer term, the development of expanded valency<br />

vaccines will be important.<br />

12 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


2.4 MeNZB TM vaccine<br />

From 1 June <strong>2008</strong>, the meningococcal B vaccine special programme will be stopped.<br />

Babies will no longer routinely be offered the MeNZB vaccine.<br />

Why is the MeNZB TM programme stopping from 1 June <strong>2008</strong><br />

The MeNZB vaccine was introduced to control an epidemic of a specific strain of<br />

Group B meningococcus circulating in New Zealand. The programme started in 2004,<br />

and by the end of December 2006, three doses of MeNZB vaccine had been offered<br />

to all children and young people aged six weeks to 19 years in New Zealand. From<br />

January 2007, the MeNZB vaccine has only been available for children under the age<br />

of five years and to individuals at higher risk.<br />

The programme will be discontinued from 1 June <strong>2008</strong> for the following reasons.<br />

• The incidence of invasive meningococcal disease has decreased from a high of<br />

651 cases in 2001, when 370 cases were found to have the epidemic strain, to<br />

105 cases in 2007, of whom, 47 individuals were confirmed as having the disease<br />

due to the epidemic strain. The Meningococcal B vaccine special programme has<br />

successfully reduced cases of meningococcal disease.<br />

• It is known from the clinical trials that protection from meningococcal disease may not<br />

be long term, suggesting that the vaccine may be best used to stop an epidemic<br />

rather than for a long-term schedule vaccine.<br />

• Coverage data from the NIR shows that only 58% of infants received the fourth dose<br />

of MeNZB vaccine at the age of 10 months (for children enrolled on the NIR from<br />

1 January 2006 to 1 January <strong>2008</strong>).<br />

• There is no data to support the co-administration of MeNZB vaccine with<br />

Prevenar® vaccine, and therefore the timing of administering the vaccines would<br />

have to be changed. Adding more visits to the immunisation programme to give<br />

three doses of MeNZB after the age of six months is unlikely to be popular with<br />

parents or health providers.<br />

Can children who have started the MeNZB TM course finish it<br />

Yes, a child may complete a course of MeNZB vaccine. Parents and children should<br />

be encouraged to complete the course before 31 December <strong>2008</strong>, although the vaccine<br />

will still be available after that date.<br />

Is the MeNZB TM vaccine still available if parents request it for their child<br />

Yes, if the parent of a child or young person up to 19 years of age requests that the<br />

child receives a course of MeNZB vaccine, and the doctor thinks the child is at risk,<br />

the MeNZB vaccine will still be available and funded. A GP may start the child’s<br />

course of MeNZB without further authorisation, and the immunisation benefit may be<br />

claimed.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 13


Avoid giving MeNZB TM at same visit as the PCV7 (Prevenar®) vaccine<br />

While no problems are anticipated, either in the immune response or safety, there is no<br />

data to support giving the MeNZB TM vaccine at the same practice visit as PCV7<br />

(Prevenar®). Therefore, where parents are anxious for their child to receive the<br />

MeNZB vaccine and the doctor agrees, a three-dose course of the MeNZB vaccine<br />

could start at six months of age (doses six weeks apart).<br />

See sections 2.3 and 5 for more information about the PCV7 (Prevenar®) vaccine.<br />

Is the MeNZB TM vaccine still available for certain occupational groups<br />

Yes, the MeNZB vaccine will still be available for microbiologist and laboratory<br />

workers. See the <strong>Immunisation</strong> Handbook 2006, page 301 (Ministry of <strong>Health</strong> 2006).<br />

Is the MeNZB TM vaccine still available for certain high-risk groups<br />

Yes, the vaccine will still be available for individuals of any age with a high risk of<br />

invasive meningococcal infection and specific conditions (three doses of MeNZB<br />

vaccines at six-week intervals). Specific conditions include:<br />

• actual or functional asplenia (Individuals scheduled for MeNZB vaccine presplenectomy<br />

will need to have completed their MeNZB vaccine course (all three<br />

doses) at least four weeks before the scheduled operation date)<br />

• sickle cell anaemia<br />

• deficiencies of the terminal complement components<br />

• individuals with HIV infection, who may be safely immunised with meningococcal<br />

polysaccharide vaccines.<br />

See the <strong>Immunisation</strong> Handbook 2006, page 302 (Ministry of <strong>Health</strong> 2006).<br />

How effective is the MeNZB TM vaccine<br />

A study looking at the effectiveness of MeNZB vaccine up to the end of December<br />

2006 estimated that the MeNZB vaccine was effective, with an estimated efficacy of<br />

68% (Kelly et al 2007). The estimate will be reassessed using data up to the end of<br />

2007.<br />

Will the MeNZB TM vaccine be recorded on the <strong>National</strong> <strong>Immunisation</strong> Register<br />

after 1 June <strong>2008</strong><br />

It is important to record all MeNZB vaccine doses given those up to 19 years of age.<br />

From 1 June <strong>2008</strong> the <strong>National</strong> <strong>Immunisation</strong> Register will continue to accept<br />

information on MeNZB vaccine doses administered to those up to 19 years of age.<br />

The NIR messaging and scheduling for the MeNZB vaccine will stop for newborns.<br />

14 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


How do I claim for the MeNZB TM vaccine given after 1 June <strong>2008</strong><br />

While no longer recommended for routine use the <strong>Immunisation</strong> Benefit may be claimed<br />

for administration of the MeNZB vaccine, where:<br />

• a doctor assesses there to be an indication of high risk of disease<br />

• parents feel that their child under twenty years of age is at special risk and the doctor<br />

agrees to MeNZB vaccination.<br />

Use claim code IMMB and the applicable indication code.<br />

Will ongoing surveillance of Meningococcal Disease continue<br />

The Ministry of <strong>Health</strong> will continue to monitor meningococcal disease and will consider<br />

reintroducing a meningococcal B immunisation programme if it is needed.<br />

Even though meningococcal B epidemic strain disease rates are low, the disease is still<br />

present. The MeNZB vaccine protects against the strain of meningococcal B causing<br />

the epidemic, but it will not protect against other strains. This is why New Zealanders<br />

should be reminded to watch out for the signs and symptoms of this disease, and seek<br />

medical help immediately if they are concerned. <strong>Health</strong> practitioners need to be aware<br />

of the risk of meningococcal disease in individuals presenting with illness particularly<br />

young children.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 15


2.5 Expansion of the high risk pneumococcal programme for<br />

children under five years of age with a chronic condition<br />

The table below shows the eligibility criteria for the high-risk pneumococcal programme<br />

for children under five years of age from 1 June <strong>2008</strong>.<br />

Table 2.2: Eligibility criteria for high-risk pneumococcal programme<br />

Children aged under five years with the following conditions:<br />

On immunosuppressive or radiation<br />

therapy<br />

Primary immune deficiencies<br />

HIV<br />

Renal failure or nephrotic syndrome<br />

Organ transplants<br />

Cochlear implants or intracranial shunts<br />

With chronic CSF leaks<br />

On corticosteroid therapy for more than two weeks, at<br />

daily dose of prednisone of 2 mg/kg or greater, or a total<br />

daily dosage of 20 mg or more<br />

Children pre or post splenectomy or with functional<br />

asplenia*<br />

Pre-term infants, born at under 28 weeks’ gestation<br />

Chronic pulmonary disease (including asthma<br />

treated with high-dose corticosteroid therapy)<br />

Cardiac disease with cyanosis or failure<br />

Insulin dependent diabetes<br />

Down’s syndrome<br />

* See Appendix 2 – Pre/post Splenectomy <strong>Immunisation</strong> Programme.<br />

Note: See bold text for the additional funded chronic conditions from 1 June <strong>2008</strong>.<br />

Children who meet the criteria are eligible for:<br />

• PCV7 (pneumococcal conjugate, Prevenar®) vaccine<br />

• 23PPV (pneumococcal polysaccharide, Pneumovax®23) vaccine.<br />

See Table 6.2 for the high risk pneumococcal programme immunisation schedule.<br />

Catch-up schedules for children who have already received one or more doses of<br />

pneumococcal vaccine are found in Appendix 1.<br />

How do I enter the high-risk pneumococcal programme vaccines on the <strong>National</strong><br />

<strong>Immunisation</strong> Register (NIR)<br />

Children born prior to 1 January <strong>2008</strong><br />

Children born prior to 1 January <strong>2008</strong> and identified as meeting the eligibility criteria for<br />

the high-risk pneumococcal programme (see Table 6.1) will continue to have their<br />

pneumococcal vaccines (PCV7 and 23PPV) entered onto the NIR using the<br />

pneumococcal programme.<br />

16 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


Children born between 1 January <strong>2008</strong> and 31 May <strong>2008</strong><br />

Children born between 1 January <strong>2008</strong> and 31 May <strong>2008</strong> who have commenced the<br />

high-risk pneumococcal programme would have already been entered on the NIR as<br />

part of the pneumococcal programme (PI). They will continue to receive PCV7 under<br />

this programme, and it will not be scheduled for them under NIR Childhood <strong>Schedule</strong><br />

(CI) <strong>2008</strong>.<br />

Children can receive PCV7 under either CI or PI programmes, with a cross-check<br />

making sure that PCV7 is not scheduled under both.<br />

From 1 June <strong>2008</strong>, these high-risk children will automatically transfer to the CI and their<br />

remaining PCV7 doses will recorded as part of this CI schedule.<br />

When the high-risk child turns two years old and receives 23PPV vaccine, the PI<br />

programme takes over for these children (on the basis of the NIR receiving a 23PPV<br />

vaccine, an indicator of high risk).<br />

Children born from 1 June <strong>2008</strong><br />

PCV7 is included on the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> from 1 June <strong>2008</strong> for all<br />

children. PCV7 doses given to high-risk children born from 1 June <strong>2008</strong> will be<br />

recorded on the CI schedule of the NIR. When the high-risk child turns two years old<br />

and receives 23 PPV vaccine, the PI programme takes over for these children (on the<br />

basis of the NIR receiving a 23 PPV vaccine, an indicator of high risk).<br />

How do I claim for high-risk pneumococcal programme vaccines<br />

The immunisation benefit can be claimed for vaccines given as part of the high-risk<br />

pneumococcal programme for children under five years of age with a chronic condition.<br />

Claim using the codes as follows:<br />

• Vaccine 100 (PCV7) and indication 12 (at risk, no previous history), 13 (at risk,<br />

previous PCV7) or 14 (at risk, previous 23 PPV).<br />

• Or, if the PCV7 vaccine is given at six weeks, three or five months as part of the<br />

usual <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> you may claim as a usual <strong>Schedule</strong> vaccine,<br />

and when the child receives a dose of 23PPV vaccine please claim under the high<br />

risk pneumococcal programme<br />

For further details on the High Risk Pneumococcal Programme for children under five<br />

years of age with chronic medical conditions refer to section 6.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 17


2.6 HPV immunisation programme<br />

More detailed information on the Human Papillomavirus (HPV) <strong>Immunisation</strong><br />

Programme will be provided later in <strong>2008</strong> once discussions with District <strong>Health</strong> Boards<br />

and the Ministry of Education are complete.<br />

What is the HPV <strong>Immunisation</strong> Programme<br />

The HPV <strong>Immunisation</strong> Programme aims to reduce cervical cancer in New Zealand by<br />

protecting girls and young women against HPV infection caused by the HPV types<br />

present in the vaccine. Currently, around 160 New Zealand women each year are<br />

diagnosed with cervical cancer and 60 women per year die from cervical cancer.<br />

Girls and young women aged 12 to 18 years will be offered the HPV vaccine<br />

(Gardasil®) to protect against the two most common infections (HPV types 16 and 18)<br />

that can lead to cervical cancer and the HPV types (6 and 11) that cause most genital<br />

warts.<br />

Who will be eligible for the HPV vaccine<br />

Girls born on or after 1 January 1990 will be eligible for the HPV vaccine. The HPV<br />

immunisation programme will be introduced in stages, beginning with the oldest girls<br />

first.<br />

From 1 September <strong>2008</strong><br />

• Girls aged 17 and 18 years (born in 1990 and 1991) will be able to receive HPV<br />

vaccine from primary care or health clinics.<br />

From 2009<br />

• HPV vaccine will be part of the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> for 12 year old girls<br />

(in primary care and health clinics) and girls in school Year 8, see Table 1.1.<br />

• HPV vaccine will be offered to girls aged 13 to 18 years. Delivery of HPV vaccine to<br />

these girls will be phased over 2009 and 2010. More information about cohort<br />

phasing will follow later in <strong>2008</strong>.<br />

What is the HPV vaccine schedule<br />

Three doses of Gardasil® are given over a six month period.<br />

Number of HPV vaccine schedule<br />

doses<br />

1 st dose<br />

2 nd dose 2 months after the 1 st dose<br />

3 rd dose 6 months after the 1 st dose<br />

(4 months after the 2 nd dose)<br />

18 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


What is HPV infection<br />

HPV is a common virus that is spread through skin to skin contact. Some types of HPV<br />

infection can cause cell changes that may lead to cervical cancer, and these types are<br />

spread through sexual contact. Other strains can cause warts but those strains do not<br />

lead to cancer. Most women who develop HPV infections clear the virus naturally and<br />

do not develop cervical cancer. About four out of five people have HPV infection at<br />

some time in their lives.<br />

There is no treatment for HPV infections, but there is treatment for the health problems<br />

that HPV can cause (such as warts, abnormal changes to cervical cells, and cancers).<br />

What is in the Gardasil® vaccine<br />

The vaccine contains HPV virus-like particles (VLPs) of HPV types 16, 18, 6 and 11.<br />

These particles are proteins from the outer shell of the virus. They are a part of the virus<br />

but are not live and cannot cause infection. The particles mimic the HPV structure so<br />

that the immune system makes antibodies against it. The vaccine does not contain<br />

thiomersal. These recombinant types of vaccine have been used around the world for<br />

about 20 years.<br />

For more vaccine information, see the Gardasil® data sheet (refer to the Medsafe data<br />

sheets at: http://www.medsafe.govt.nz/profs/Datasheet/dsform.asp).<br />

How effective is the HPV vaccine, and how long does it last<br />

Gardasil® vaccine targets the types of HPV responsible for most cases of cervical<br />

cancer (types 16 and 18) and genital warts (types 6 and 11). Clinical trials show<br />

Gardasil® is highly effective in preventing these types of HPV in young women who<br />

have not previously been exposed to them.<br />

So far, ongoing studies show the vaccine protects against HPV infection for five years<br />

after immunisation, and suggest protection will last much longer. Research is continuing<br />

to find out how long protection will last.<br />

Gardasil® does not protect against all types of HPV that can cause cervical cancer.<br />

And, as with any vaccine, Gardasil® may not provide protection for everyone who is<br />

vaccinated.<br />

<strong>National</strong> Cervical Screening Programme<br />

There will be no changes to the <strong>National</strong> Cervical Screening Programme. All women<br />

should have regular cervical smear tests every three years from the age of 20 until they<br />

turn 70 if they have been sexually active.<br />

How safe is the HPV vaccine<br />

Vaccine safety was assessed in five clinical trials (four of which were placebo<br />

controlled); 6,160 subjects received Gardasil® and 4,064 received placebo.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 19


Reported reactions at one to five days post-vaccination included:<br />

• pain at the injection site (81%)<br />

• swelling (24%)<br />

• redness (23%)<br />

• erythema (3%)<br />

• pruritis (3%).<br />

Overall, 94% rated their injection-site adverse experience to be mild or moderate in<br />

intensity.<br />

Ten percent of vaccinees experienced fever. Bronchospasm was reported very rarely.<br />

There have been post-approval reports of fainting (syncope) occurring after vaccination<br />

with Gardasil®. This can follow any vaccination and requires careful observation of the<br />

person being vaccinated for at least 15 minutes after administration.<br />

Other adverse experiences reported during post-approval use have been reported,<br />

however it is difficult to accurately quantify and determine causation. Other reported<br />

adverse experiences include: lymphadenopathy, dizziness, headache, Guillian-Barre<br />

syndrome, nausea, vomiting, arthralgia, myalgia, fatigue, and malaise.<br />

Gardasil has been licensed for use in more than 100 countries, including New Zealand,<br />

Australia, Canada, the United States, and the 27 countries in the European Union<br />

including the United Kingdom.<br />

Will the HPV vaccine be recorded on the <strong>National</strong> <strong>Immunisation</strong> Register<br />

The <strong>National</strong> <strong>Immunisation</strong> Register will record HPV vaccine events given as part of the<br />

HPV <strong>Immunisation</strong> Programme and <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>.<br />

The School Based Vaccination System (SBVS) will be updated for the introduction of<br />

the HPV vaccine. The SBVS will message HPV vaccine information to the NIR.<br />

Further information on how to record HPV vaccine information on the NIR and SBVS<br />

will be provided later in <strong>2008</strong>.<br />

How do I claim the immunisation benefit for the HPV vaccine<br />

Claiming the immunisation benefit for the HPV vaccine will be through the standard<br />

<strong>Health</strong>PAC claiming process. The immunisation benefit will be the same as that paid<br />

for other <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> vaccines.<br />

20 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


2.7 New schedule vaccine presentation and administration<br />

Vaccine Packs Cold chain Vaccine reconstitution Vaccine<br />

administration<br />

Boostrix<br />

Boostrix 10-dose box<br />

contains:<br />

10 x 1 – dose pre-filled syringes<br />

Terumo Luer needles:<br />

10 x 25G x 5/8”, 0.5 mm x<br />

16 mm<br />

10x 23G X 1”, 0.6 mm x 25 mm<br />

(Needles not attached)<br />

Box dimensions = 120 x 90 x<br />

120 mm<br />

Boostrix single dose box<br />

contains:<br />

1 x 1-dose pre-filled syringe<br />

Terumo Luer needles:<br />

1 x 25G x 5/8”, 0.5 mm x 16 mm<br />

1 x 23G x 1”, 0.6 mm x 25 mm<br />

(Needles not attached)<br />

Box dimensions = 50 x 40 x<br />

30 mm<br />

dTap vaccine should be<br />

stored between +2°C to<br />

+8°C.<br />

dTap vaccine should not<br />

be frozen. If frozen, dTap<br />

vaccine should be<br />

discarded.<br />

Upon removal from a<br />

refrigerator, the vaccine is<br />

stable for eight hours at<br />

21°C.<br />

Not required as a pre-filled<br />

syringe<br />

Each 0.5 mL dTap<br />

vaccine is administered<br />

by deep intramuscular<br />

injection to the deltoid.<br />

Infanrix®-<br />

Hexa<br />

Infanrix®-hexa box contains:<br />

10 pre-filled syringes, containing<br />

0.5 mL DTap-IPV-HepB<br />

suspension<br />

10 glass vials, containing the<br />

Hib pellet<br />

Terumo Luer needles:<br />

10 x 25G x 5/8" 0.5 mm x 16<br />

mm<br />

10 x 23G x 1" 0.6 mm x 25 mm<br />

(Needles are not attached)<br />

Box dimensions = 116 x 200 x<br />

51 mm<br />

Infanrix®-hexa vaccine<br />

should be stored between<br />

+2°C and +8°C. Protect<br />

from light.<br />

The Infanrix®-hexa<br />

suspension and the<br />

reconstituted vaccine<br />

should not be frozen.<br />

Discard if frozen.<br />

After reconstitution, the<br />

vaccine should be injected<br />

promptly. However, the<br />

vaccine may be kept for up<br />

to eight hours at room<br />

temperature (21°C).<br />

Attach the 25-gauge needle<br />

to the pre-filled syringe.<br />

Transfer the syringe’s liquid<br />

suspension to the vial<br />

containing the Hib pellet.<br />

Shake the vial well to<br />

ensure the Hib pellet is<br />

completely dissolved.<br />

Draw the reconstituted<br />

vaccine back into the<br />

syringe.<br />

Attach the 23-gauge needle<br />

to the syringe for vaccine<br />

administration.<br />

After reconstitution, the<br />

vaccine should be injected<br />

promptly.<br />

However, the vaccine may<br />

be kept for up to eight<br />

hours at room temperature<br />

(21°C).<br />

Each 0.5 mL dose of<br />

the reconstituted<br />

vaccine is given by<br />

deep intramuscular<br />

injection into the thigh.<br />

Note: Infanrix®-hexa<br />

and Prevenar®<br />

vaccines are given in<br />

separate limbs<br />

Prevenar<br />

Packs of 10 x 1-dose pre-filled<br />

syringes<br />

Box dimensions = 150 x 110 x<br />

50 mm (LxWxH)<br />

Note: Needles are not supplied<br />

with the vaccine<br />

PCV7 vaccine should be<br />

stored between +2°C and<br />

+8°C.<br />

PCV7 vaccine should not<br />

be frozen.<br />

If frozen, PCV7 vaccine<br />

should be discarded.<br />

Not required as a pre-filled<br />

syringe.<br />

Each 0.5mL PCV7 dose<br />

is given intramuscularly.<br />

The preferred injection<br />

sites are:<br />

• the anterolateral<br />

aspect of the thigh<br />

of infants and young<br />

children<br />

• the deltoid muscles<br />

of the upper arm of<br />

older children<br />

Note: Infanrix®-hexa<br />

and Prevenar®<br />

vaccines are given in<br />

separate limbs.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 21


Vaccine Packs Cold chain Vaccine reconstitution Vaccine<br />

administration<br />

Gardasil®<br />

Packs of 10 x 1-dose pre-filled<br />

syringes<br />

Box dimensions = 95 x 87 x<br />

150mm<br />

Note: Needles are not supplied<br />

with the vacccine<br />

Gardasil vaccine should<br />

be stored between +2°C<br />

and +8°C.<br />

Gardasil vaccine should<br />

not be frozen.<br />

Protect Gardasil from light.<br />

Gardasil should be<br />

administered as soon as<br />

possible after being<br />

removed from<br />

refrigeration. Gardasil can<br />

be out of refrigeration at<br />

temperatures, at or below<br />

25°C, for a total time of not<br />

more than 72 hours.<br />

Not required as a pre-filled<br />

syringe<br />

Shake well before use.<br />

Thorough agitation<br />

immediately before<br />

administration is necessary<br />

to maintain suspension of<br />

the vaccine.<br />

After thorough agitation,<br />

Gardasil is a white, cloudy<br />

liquid. Parenteral drug<br />

products should be<br />

inspected visually for<br />

particulate matter and<br />

discolouration prior to<br />

administration. Discard the<br />

product of particulates are<br />

present or if it appears<br />

discoloured.<br />

Each 0.5 mL Gardasil<br />

dose should be<br />

administered<br />

intramuscularly.<br />

The preferred injection<br />

sites are:<br />

• In the deltoid region<br />

of the upper arm<br />

• In the higher<br />

anterolateral area of<br />

the thigh.<br />

22 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


3 dTap (Boostrix) Vaccine and Pertussis<br />

Epidemiology<br />

3.1 dTap (Boostrix TM ) vaccine schedule<br />

From 1 January <strong>2008</strong>, 11 year olds (or school-aged year 7 students) receive one dose<br />

of the adult diphtheria, tetanus, adult acellular pertussis (dTap, Boostrix TM ) vaccine.<br />

Note: dTap vaccine is delivered as a school-based (year 7) immunisation programme in<br />

the North Island and Nelson Marlborough DHBs and by primary health care services in<br />

the remainder of the South Island.<br />

3.2 Rationale for introducing the dTap vaccine<br />

Previous schedule changes<br />

From 1 January <strong>2008</strong>, year 7 students (11 years of age) are offered dTap (Boostrix TM )<br />

vaccine. From <strong>2008</strong> (due to previous schedule changes), all 11-year-old students will<br />

have already received the recommended four doses of polio vaccine in childhood.<br />

Therefore dTap-IPV (Boostrix®-IPV) vaccine is no longer required (see the<br />

<strong>Immunisation</strong> Handbook 2006, chapter 8, page 199 (Ministry of <strong>Health</strong> 2006).<br />

3.3 Pertussis epidemiology<br />

Pertussis-containing vaccine was added to the schedule in 2006 because children at<br />

11 years of age had only received pertussis vaccine in their first year of life. These<br />

children are at risk from pertussis due to:<br />

• variable immunisation coverage<br />

• the whole-cell pertussis vaccine used before 2000 was around 80% effective after<br />

three doses<br />

• a child’s immunity wanes over time.<br />

If immunity is not boosted either with vaccine or natural infection, the population<br />

gradually becomes increasingly susceptible to pertussis infection, and eventually an<br />

epidemic occurs. In New Zealand, the most recent epidemic of pertussis was in 2004/5,<br />

see Figure 3.1. As can be seen in Figure 3.2, in 2004, older children, and many<br />

adolescents and adults developed pertussis – and they are known to have passed the<br />

pertussis infection on to babies and infants.<br />

The acellular pertussis vaccine booster (as dTap, Boostrix TM ) given at age 11 years<br />

provides protection against the disease during adolescence.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 23


Figure 3.1: Notifications of pertussis in New Zealand (all ages), 2001–2007<br />

Pertussis notifications by month Sept 2001 to Sept 2007<br />

650<br />

600<br />

550<br />

500<br />

Number of notifications<br />

450<br />

400<br />

350<br />

300<br />

250<br />

200<br />

4th dose of<br />

pertussis vaccine<br />

at age 4 years<br />

Pertussis vaccine<br />

to 11 year olds<br />

150<br />

100<br />

50<br />

0<br />

Sep-01<br />

Dec-01<br />

Mar-02<br />

Jun-02<br />

Sep-02<br />

Dec-02<br />

Mar-03<br />

Jun-03<br />

Sep-03<br />

Dec-03<br />

Mar-04<br />

Jun-04<br />

Sep-04<br />

Dec-04<br />

Mar-05<br />

Jun-05<br />

Sep-05<br />

Dec-05<br />

Mar-06<br />

Jun-06<br />

Sep-06<br />

Dec-06<br />

Mar-07<br />

Jun-07<br />

Sep-07<br />

Month<br />

Source: ESR monthly surveillance reports<br />

http://www.surv.esr.cri.nz/surveillance/monthly_surveillance.php<br />

Figure 3.2: Age-specific rates of pertussis in New Zealand 2000–2006<br />

Age specific rates of pertussis notifications (expansion of Fig 6.2 page 166 Imm<br />

Handbook) http://www.surv.esr.cri.nz/surveillance/annual_surveillance.php<br />

800<br />

700<br />

600<br />

Rate per 100,000<br />

500<br />

400<br />

300<br />

200<br />

2000<br />

2004<br />

2005<br />

2006<br />

100<br />

0<br />


3.4 dTap (Boostrix TM ) vaccine information<br />

For detailed dTap (Boostrix TM ) vaccine information refer to:<br />

• the Boostrix TM data sheet (refer to the Medsafe data sheets at:<br />

http://www.medsafe.govt.nz/profs/Datasheet/dsform.asp)<br />

• the <strong>Immunisation</strong> Handbook 2006 (Ministry of <strong>Health</strong> 2006).<br />

dTap (Boostrix TM ) vaccine presentation<br />

Pack 10-dose syringe Single-dose syringe<br />

Dimensions (L x W x H) 120 x 90 x 120 mm 50 x 40 x 30 mm<br />

Contents 10 x 1-dose pre-filled syringes 1 x 1-dose pre-filled syringe<br />

Needle size<br />

(gauge and length)<br />

Needle not attached<br />

10 x Terumo Luer:<br />

25G x 5/8”, 0.5 mm x 16 mm<br />

23G X 1”, 0.6 mm x 25 mm<br />

1 s Terumo Luer<br />

25G x 5/8”, 0.5 mm x 16 mm<br />

23G x 1”, 0.6 mm x 25 mm<br />

The 10-dose packs are mainly distributed to school-based programmes. However, if a<br />

GP orders large quantities, then the 10-dose packs will be sent.<br />

Cold chain management<br />

• dTap vaccine should be stored between +2°C to +8°C.<br />

• dTap vaccine should not be frozen. If frozen, dTap vaccine should be discarded.<br />

• Upon removal from a refrigerator, the vaccine is stable for eight hours at 21°C.<br />

dTap vaccine administration<br />

Each 0.5 mL dTap vaccine is administered by deep intramuscular injection to the<br />

deltoid.<br />

dTap vaccine immunogenicity and expected efficacy<br />

Based on the results of immunogenicity studies using dTap, the likely protective effect<br />

of dTap can be inferred by comparing these results to studies of the immunogenicity of<br />

DTaP (Infanrix) and Td vaccine.<br />

Anti-diphtheria and anti-tetanus antibody titres of above 0.01 IU/mL are generally<br />

accepted to be protective against tetanus and diphtheria (Wharton & Vitek 2004). In two<br />

adolescent studies, dTap was highly immunogenic for the diphtheria and tetanus toxoid<br />

components, with all participants having post-vaccination anti-tetanus and antidiphtheria<br />

antibody titres of at least 0.1 IU/mL and 93 to100% with titres of at least 1.0<br />

IU/mL (Minh et al 1999).<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 25


No equivalent serological correlate of protection has been identified for pertussis.<br />

Therefore, the evaluation of the immunogenicity of the pertussis component of dTap<br />

(Boostrix TM ) is based on:<br />

• the ability of Boostrix TM to induce a response to each of the pertussis components<br />

(defined as seroconversion in initially seronegative people or a minimum of two-fold<br />

rise in antibody titre in initially seropositive people)<br />

• the immunogenicity of the pertussis components in the combined vaccine compared<br />

with the monovalent acellular pertussis vaccine in comparative studies<br />

• antibody studies compared with those obtained in infants given Infanrix (DTaP<br />

vaccine, GSK) at three, four and five months, in whom the protective efficacy of<br />

Infanrix against WHO-defined pertussis was 88.7% (95% confidence interval [CI]:<br />

76.6–94.6%) (Schmitt et al 1997).<br />

In the adolescent studies with Boostrix TM , a response of more than 92% was recorded<br />

for each of the pertussis antigens, and 97% of the adolescents were seropositive<br />

30 days after vaccination.<br />

There were no differences between the response to the pertussis components of<br />

Boostrix TM and responses to a monovalent acellular pertussis vaccine. Current expert<br />

opinion therefore suggests that the efficacy of a primary acellular pertussis vaccine can<br />

serve as basis for efficacy of that vaccine when administered as a booster to older age<br />

groups at the same or a lower dose.<br />

The duration of protection against tetanus and diphtheria after Boostrix TM is expected to<br />

be the same as after Td vaccine.<br />

There are so far few published studies of the efficacy of dTap (Boostrix TM ) in preventing<br />

pertussis in adolescent and adult age groups. However, a randomised controlled trial in<br />

the United States of dTap (Boostrix TM , GSK) and a control vaccine enrolled 2781<br />

adolescents and adults aged between 15 and 65 years. Safety, immunogenicity and<br />

efficacy were studied after a single dose of dTap or a control vaccine during a 2½-year<br />

follow-up (Ward et al 2005). During follow-up, there were nine cases of pertussis<br />

fulfilling the primary case definition in the control group and one case of pertussis in the<br />

group that received the acellular pertussis vaccine, giving an overall efficacy of 92%<br />

(95% CI 32–99%) when adjusted for the duration of illness and 89% (95% CI 19–99%)<br />

unadjusted for the duration of illness. During the two years of follow-up, the rate of<br />

pertussis in the control group was 370 cases per 100,000 person-years.<br />

A booster dose of dTap (Boostrix TM ) is expected to protect adolescents against<br />

pertussis. A booster of dTap, if given to the immediate close contacts of newborn<br />

infants, such as to parents, grandparents and health care workers, is expected to<br />

reduce exposure of pertussis to newborn infants and infants not yet adequately<br />

protected through immunisation.<br />

26 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


Expected responses (ER) and adverse events following immunisation with dTap<br />

vaccine<br />

The dTap vaccine was assessed as safe and immunogenic during clinical trials. The<br />

following may be the expected local responses (ERs) following immunisation after<br />

Boostrix TM (CDC 2006):<br />

• pain in 75% of recipients, of which 2% were severe (defined as spontaneously painful<br />

and/or preventing normal everyday activities)<br />

• swelling in 21% (of which 2.5% ≥ 50 mm) at injection site<br />

• redness in 23% (of which 1.7% ≥ 50 mm).<br />

All these local ERs are greater if tetanus vaccine were received from three to less than<br />

five years previously compared with a longer gap. Other expected reactions include:<br />

• limitation of movement<br />

• headaches (in 16%; 0.7% severe)<br />

• body ache<br />

• sore joints.<br />

Expected reactions after Boostrix TM are at least equal to those expected after Td<br />

vaccination. The incidence of clinically significant adverse events after vaccination with<br />

Boostrix TM are as low as those after Td booster.<br />

Rare events after Boostrix TM , in 1/100 to 1/1000 patients, include:<br />

• pruritis<br />

• sweating<br />

• myalgia<br />

• arthrosis<br />

• hypertonia<br />

• lymphadenopathy.<br />

dTap vaccine contraindications<br />

Contraindications to dTap vaccine include: known hypersensitivity to any component of<br />

the vaccine or individuals who have shown signs of hypersensitivity after a previous<br />

administration of diphtheria, tetanus or pertussis vaccines.<br />

3.5 Other recommendations<br />

What if Tetanus-diphtheria vaccine has been given in the past two years<br />

The 11-year-old dTap vaccine should be delayed until two years after receipt of a tetanusdiphtheria<br />

vaccine (for example, Td booster after an injury). This delay in administering<br />

dTap aims to decrease the risk and severity of a local reaction at the injection site. This<br />

precaution may be waived if a pertussis epidemic is beginning and the student lives in a<br />

household with an unimmunised younger sibling or a pregnant woman.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 27


If the student received a Td vaccine booster three to five years ago, dTap immunisation<br />

is recommended.<br />

School-based programmes: referral to GPs<br />

Students who have received a Td vaccine in the past two years should be referred to<br />

their GP for follow-up and recall. The dTap vaccine should be offered to these students<br />

before they reach 16 years of age.<br />

Primary care<br />

Students who have received Td in the past two years should be followed up and<br />

recalled for dTap immunisation before they reach 16 years of age.<br />

Polio vaccine history<br />

Students at age 11 years who have an unknown immunisation history for polio vaccine<br />

or who have received three or less polio vaccine doses should complete a four-dose<br />

series of IPV vaccine from their GP.<br />

Note: The polio vaccine history will not be checked in school programmes.<br />

Incomplete tetanus, diphtheria pertussis vaccination history<br />

Two doses of Td plus one of dTap are recommended, one month apart (see the<br />

<strong>Immunisation</strong> Handbook 2006, Appendix 2, pages 395–6; Ministry of <strong>Health</strong> 2006).<br />

Alternatively, three doses of dTap, one month apart, may be given, although as yet<br />

there are no studies looking at the effectiveness of Boostrix TM used in this way.<br />

See the <strong>Immunisation</strong> Handbook 2006, chapter 6, pages 171–2; Ministry of <strong>Health</strong><br />

2006) for non-funded pertussis vaccine recommendations for other groups.<br />

3.6 <strong>National</strong> <strong>Immunisation</strong> Register and School Based Vaccination<br />

System<br />

The SBVS has been updated for the use of the dTap vaccine in the Year 7 School<br />

<strong>Immunisation</strong> Programme. The SBVS will not provide information of dTap vaccine<br />

events to the NIR.<br />

In primary health care services dTap vaccine will not be recorded on the NIR because<br />

11-year-old students are not in the birth cohort registered on the NIR.<br />

28 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


4 DTaP-IPV-HepB/Hib (INFANRIX ® -hexa)<br />

4.1 Early introduction of DTaP-IPV-HepB/Hib from March <strong>2008</strong><br />

Due to Hib-HepB (Comvax®) vaccine manufacturing problems, New Zealand is not able<br />

to secure further supplies of Comvax® vaccine.<br />

Stocks of Comvax® vaccine have run out, and therefore DTaP-IPV-HepB/Hib<br />

(Infanrix®-hexa) vaccine is now available.<br />

4.2 DTaP-IPV-HepB/Hib vaccine schedule – from 1 June <strong>2008</strong><br />

DTaP-IPV-HepB/Hib vaccine will replace the 2006 schedule vaccine combinations given<br />

at six weeks, three months and five months of age.<br />

The introduction of Infanrix®-hexa vaccine means there will be two injections given at<br />

six weeks and three and five months of age (Prevenar® and Infanrix®-hexa).<br />

A change of vaccine within a primary series is safe and expected to be effective.<br />

Giving alternative vaccines to the DTaP-IPV-HepB/Hib vaccine<br />

When a child has a genuine contraindication to a component of the Infanrix®-hexa<br />

vaccine, alternative vaccines (if available) may be given and the immunisation benefit<br />

claimed.<br />

4.3 Change in type of Hib vaccine<br />

Using Infanrix®-hexa vaccine changes the Hib vaccine component from Hib-PRP-OMP<br />

(polyribosylribitol phosphate outer membrane protein) to Hib-PRP-T (polyribosylribitol<br />

phosphate chemically conjugated to tetanus toxoid).<br />

Hib-PRP-OMP vaccine was previously used as a schedule vaccine because it offers<br />

protection after a single dose – as early as six weeks of age. There is a small risk that<br />

Hib disease will re-emerge with a change to Hib-PRP-T vaccine. However, the<br />

incidence of Hib disease in New Zealand has significantly declined since Hib vaccine<br />

was introduced in 1994, with 5 to 10 cases occurring every year in unimmunised or<br />

incompletely immunised children. Hib disease will be monitored carefully using the<br />

surveillance systems following the change of vaccine to Hib-PRP-T.<br />

4.4 DTaP-IPV-HepB/Hib vaccine information<br />

For detailed DTaP-IPV-HepB/Hib vaccine information, refer to the Infanrix®-hexa<br />

vaccine data sheet (refer to the Medsafe data sheets at:<br />

http://www.medsafe.govt.nz/profs/Datasheet/dsform.asp)<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 29


Pack and needle information<br />

The DTaP-IPV-HepB/Hib vaccine (Infanrix®-hexa) box contains:<br />

• 10 pre-filled syringes, containing 0.5 mL DTap-IPV-HepB suspension<br />

• 10 glass vials, containing the Hib pellet.<br />

Box dimensions = 116 x 200 x 51 mm (L x W x H).<br />

Brand needle size (gauge and length):<br />

• 10 x Terumo Luer 25G x 5/8” 0.5 mm x 16 mm.<br />

• 10 x Terumo Luer 23G x 1” 0.6 mm x 25 mm.<br />

Needles are not attached.<br />

Cold chain management<br />

Infanrix®-hexa vaccine should be stored between +2°C and +8°C. Protect from light.<br />

The DTap-IPV-HepB suspension and the reconstituted vaccine should not be frozen.<br />

Discard if frozen.<br />

After reconstitution, the vaccine should be injected promptly. However, the vaccine may<br />

be kept for up to eight hours at room temperature (21°C).<br />

Infanrix®-hexa vaccine reconstitution<br />

Infanrix®-hexa must be reconstituted prior to use as follows:<br />

• Attach the 25-gauge needle to the pre-filled syringe.<br />

• Transfer the syringe’s liquid suspension to the vial containing the Hib pellet.<br />

• Shake the vial well to ensure the Hib pellet is completely dissolved.<br />

• Draw the reconstituted vaccine back into the syringe.<br />

• Attach the 23-gauge needle to the syringe for vaccine administration.<br />

• After reconstitution, the vaccine should be injected promptly.<br />

• However, the vaccine may be kept for up to eight hours at room temperature (21°C).<br />

DTaP-IPV-HepB/Hib vaccine administration<br />

Each 0.5 mL dose of the reconstituted vaccine is given by deep intramuscular injection<br />

into the thigh. Infanrix®-hexa and Prevenar® vaccines are given in separate limbs.<br />

30 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


DTaP-IPV-HepB/Hib vaccine efficacy<br />

Immunological data<br />

One month after a three-dose primary course of Infanrix®-hexa:<br />

• 98.5 to 100% of infants had antibody titres of ≥ 0.1 IU/mL for both tetanus and<br />

diphtheria<br />

• the response rate for each of the pertussis antigens (pertussis toxoid, filamentous<br />

haemaglutinin and pertactin) was between 97.2 and 99.3%, 95.2 and 100%, and 95.9<br />

and 99.3% respectively<br />

• there are no correlates of protection for the pertussis components. However,<br />

protective efficacy of Infanrix®-hexa may be inferred from the DTaP (Infanrix) trials<br />

where the DTaP vaccine was found to be 88.7% effective against WHO defined<br />

pertussis (21 days of typical paroxysmal cough) (German study). In an Italian study<br />

using Infanrix, an efficacy of 84% was confirmed at 60 months after completion of the<br />

primary series (Italy)<br />

• Hepatitis B component: 98.5 to 100% of infants developed protective antibody titres<br />

of ≥ 10 mIU/mL<br />

• Inactivated poliovirus (IPV) component: the seroprotection rates for each of the three<br />

serotypes (types 1, 2 and 3) were 99.2 to 100%, 94.5 to 99% and 98.8 to 100%<br />

respectively<br />

• Hib: the Geometric Mean Concentration (GMC) of antibodies ranged from 1.52 to<br />

3.53 μg/mL, with 93.5 to 100% of subjects reaching antibody titres of ≥ 0.15 μg/mL<br />

• Hib: the GMCs are lower than that elicited by the separate Hib component but are not<br />

different from those elicited by the licensed DTaP/Hib vaccine.<br />

A recent study from Germany (Kalies <strong>2008</strong>) showed there were no cases of<br />

haemophilus influenzae type b invasive disease following a four-dose hexavalent<br />

vaccine series in a five-year follow-up in Germany. The hexavalent vaccines (including<br />

Infanrix®-hexa) were highly effective 10% in this study.<br />

Post-marketing surveillance has shown that over a two-year follow-up period, the<br />

effectiveness of a three-dose primary series of DTaP/Hib or DTaP-IPV/Hib was 98.8%.<br />

Interference with other vaccines<br />

Data on concomitant administration of Infanrix®-hexa with Prevenar® have shown no<br />

clinically relevant interference in the antibody response to each of the individual<br />

antigens when given as a three-dose primary vaccination.<br />

Premature babies<br />

Limited data in 169 premature infants indicate that Infanrix®-hexa can be given to<br />

premature children. However, a lower immune response may be observed, and the<br />

level of clinical protection remains unknown.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 31


Expected responses and adverse events following immunisation with DTaP-IPV-<br />

HepB/Hib vaccine<br />

In ≥ 10% of vaccine recipients:<br />

• loss of appetite<br />

• irritability<br />

• restlessness<br />

• abnormal crying<br />

• pain, redness and swelling at the injection site<br />

• fever (> 38°C)<br />

• fatigue.<br />

In ≥ 1% and < 10% of vaccine recipients:<br />

• vomiting<br />

• diarrhoea<br />

• local swelling and induration at injection site (≥ 50 mm)<br />

• fever > 39.5°C.<br />

Infanrix®-hexa and Prevenar®<br />

A higher incidence of fever (> 39.5°C) was reported in infants receiving Infanrix®-hexa<br />

and Prevenar® compared to infants receiving Infanrix®-hexa vaccine alone. 1.2% after<br />

the first dose of Infanrix®-hexa and PCV7 compared with 0.6 after Infanrix®-hexa alone.<br />

Of infants with a temperature > 39.5°C after the first dose 4.6 had received Infanrix®hexa<br />

and PCV7 compared with 1.8 with Infanrix®-hexa alone. After the third dose of<br />

Infanrix®-hexa and PCV7 2.4% had a fever > 39.5°C (Tichmann-Schumann, 2005).<br />

How to manage fever<br />

• Give the baby extra fluids to drink (more breastfeeds or water).<br />

• Do not overdress the baby if hot.<br />

• Paracetamol may be given for pain relief prior to immunisation.<br />

DTaP-IPV-HepB/Hib vaccine contraindications<br />

DTaP-IPV-HepB/Hib vaccine should not be administered to subjects with known<br />

hypersensitivity to the active substances or to any of the excipients or residuals or to<br />

subjects having shown signs of hypersensitivity after previous administration of<br />

diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines.<br />

DTaP-IPV-HepB/Hib vaccine is contraindicated if the child has experienced an<br />

encephalopathy of unknown aetiology, occurring within seven days following previous<br />

vaccination with pertussis containing vaccine. In these circumstances, pertussis<br />

vaccination should be discontinued and the vaccination course should be continued with<br />

diphtheria-tetanus, hepatitis B, inactivated polio and Hib vaccines.<br />

32 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


4.5 DTaP-IPV-HepB/Hib vaccine and the <strong>National</strong> <strong>Immunisation</strong><br />

Register<br />

PMS and NIR upgrades for Infanrix®-hexa are expected from 1 June <strong>2008</strong>.<br />

Before 1 June <strong>2008</strong>, enter Infanrix®-hexa into the Patient Management System (PMS)<br />

as two separate vaccines (two events). Therefore:<br />

• enter Hib-HepB (or HepB) and then enter DTaP-IPV as separate events (as you<br />

currently do with the 2006 <strong>National</strong> Childhood <strong>Immunisation</strong> <strong>Schedule</strong>)<br />

• enter the same Infanrix®-hexa batch number and expiry date into both events’ batch<br />

number and expiry field.<br />

Note: Prior to 1 June <strong>2008</strong>, this will be recorded in your PMS and the NIR as if two<br />

separate vaccinations were given.<br />

From 1 June <strong>2008</strong>, the NIR will record DTaP-IPV-HepB/Hib vaccine events as part of<br />

the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>.<br />

4.6 DTaP-IPV-HepB/Hib vaccine and claiming the immunisation<br />

benefit<br />

<strong>Health</strong>PAC payment systems will not be updated for Infanrix®-hexa until 1 June <strong>2008</strong>.<br />

Before 1 June <strong>2008</strong>, for the six-week, three and five-months events claim as though<br />

DTaP-IPV and Hib-HepB or HepB vaccines were given, that is, record the DTaP-IPV-<br />

HepB/Hib (Infanrix®-hexa) vaccination event as if two separate vaccinations were<br />

given.<br />

From 1 June <strong>2008</strong>, <strong>Health</strong>PAC payment systems will accept claims for the DTaP-IPV-<br />

HepB/Hib (Infanrix®-hexa) vaccine.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 33


5 Pneumococcal Conjugate Vaccine (PCV7,<br />

Prevenar ® ) and Pneumococcal Epidemiology<br />

5.1 PCV7 vaccine schedule – from 1 June <strong>2008</strong><br />

From 1 June <strong>2008</strong>, all new babies beginning their childhood immunisations will be<br />

offered PCV7 vaccine. These babies will receive four doses of PCV7 vaccine at the<br />

same time as other <strong>Schedule</strong> vaccines – at six weeks and three, five and 15 months of<br />

age (see the <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> table in section 1).<br />

In addition, from 1 June <strong>2008</strong>, all babies born from 1 January <strong>2008</strong> are eligible to<br />

receive PCV7 vaccine. For these babies, a catch-up schedule applies – see Table 5.1<br />

below.<br />

Table 5.1: PCV7 vaccine schedule<br />

Age of baby at PCV7 dose 1<br />

PCV7 vaccine schedule<br />

6 weeks to 6 months 6 weeks, 3 months, 5 months, 15 months of age three doses 6 to 8<br />

weeks apart + one dose at age 15 months<br />

7 months to 11 months of age* Two doses 6 weeks apart + one dose at age 15 months<br />

12 to 23 months* Two doses of PCV7 given 6 to 8 weeks apart<br />

* Applies only to babies born from 1 January <strong>2008</strong>.<br />

5.2 Pneumococcal disease<br />

Streptococcus pneumoniae (pneumococcus) is a lance shaped gram-positive<br />

diplococcus. It is ubiquitous, with many asymptomatic individuals carrying the organism<br />

in the upper respiratory tract.<br />

There are some 90 identifiable serotypes of S. pneumoniae. Some, more commonly<br />

affect children, while others are of greater significance in adults.<br />

Transmission of the pneumococcus is from person to person, usually by droplet contact.<br />

The emergence of antibiotic-resistant strains of S. pneumoniae has become an<br />

increasing concern both in New Zealand and internationally for the management of IPD.<br />

ESR analysis of S. pneumoniae isolates from invasive pneumococcal disease (IPD) in<br />

2004 found that 16.4% of isolates were resistant to penicillin, and 12.1% were resistant<br />

to cefotaxime. Ninety-eight percent of penicillin-resistant serotypes and 94% of the<br />

serotypes resistant to third-generation cephalosporins would be covered by the PCV7<br />

vaccine (Heffernan et al 2006). This suggests that introduction of the PCV7 vaccine will<br />

reduce disease caused by antibiotic resistant S. pneumoniae isolates.<br />

The spectrum of disease caused by pneumococcal bacteria<br />

Pneumococcal disease can cause otitis media at the mildest (but most frequent) end of<br />

the disease spectrum and pneumococcal meningitis and death at the most severe (but<br />

34 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


less frequent) end of the spectrum (see Figure 5.1). PCV7 vaccine is most effective<br />

against severe pneumococcal disease.<br />

Figure 5.1: Pneumococcal disease spectrum (for use as a guide only)<br />

Disease frequency<br />

Otitis media<br />

Pneumococcal<br />

pneumonia<br />

Pneumococcal<br />

bacteraemia<br />

Pneumococcal<br />

meningitis<br />

PCV 7<br />

effect on<br />

disease<br />

Increasing disease severity<br />

Increasing PCV7 vaccine effectiveness<br />

against disease<br />

The pneumococcus may also cause endocarditis, and, less commonly, sites such as<br />

joints, the peritoneal cavity and the fallopian tubes are affected.<br />

IPD is defined as isolation of Streptococcus pneumoniae from a normally sterile site,<br />

usually blood or cerebrospinal fluid (CSF) but also from pleural tissue or other sterile<br />

sites. The major clinical syndromes of IPD include pneumonia with bacteraemia,<br />

meningitis and bacteraemia without focus.<br />

Non-invasive pneumococcal diseases include otitis media, sinusitis and (nonbacteraemic)<br />

pneumonia.<br />

The incubation period of S. pneumoniae infection is variable but may be as short as one<br />

to three days. Illness usually occurs within one month of acquiring a new serotype in<br />

the upper respiratory tract and does not usually result in prolonged carriage of the<br />

organism.<br />

See the <strong>Immunisation</strong> Handbook 2006, chapter 16: Pneumococcal Disease for more<br />

information (Ministry of <strong>Health</strong> 2006).<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 35


5.3 Epidemiology<br />

Pneumococcal disease occurs throughout the year but is more common in the autumn<br />

and winter months (Kelly et al 2007).<br />

The risk of IPD is much higher in infants and elderly people and more frequent in<br />

individuals with predisposing conditions such as viral upper respiratory tract infections<br />

or underlying conditions such as immune deficiency states. Mortality is highest in<br />

patients with underlying medical conditions.<br />

These conditions include:<br />

• congenital or acquired immune deficiency<br />

• splenic dysfunction or asplenia<br />

• sickle cell anaemia<br />

• Hodgkin’s disease<br />

• human immunodeficiency virus (HIV) infection<br />

• cochlear implants or intracranial shunts<br />

• chronic cerebrospinal fluid leaks<br />

• following organ transplantation.<br />

Other conditions/factors that increase the risk of pneumococcal infection include:<br />

• diabetes mellitus<br />

• congestive heart failure<br />

• chronic pulmonary disease<br />

• renal failure<br />

• pre-term infants<br />

• children attending early childhood services<br />

• Māori and Pacific children.<br />

Patients with CSF leakage due to a fracture at the base of the skull or following a<br />

neurosurgical procedure are at risk of recurrent pneumococcal meningitis.<br />

New Zealand epidemiology<br />

ESR serotyping and antibiotic resistance testing<br />

Pneumococcal invasive disease caused by S. pneumoniae is monitored in New Zealand<br />

through ESR testing of laboratory isolates from cases of invasive disease. All<br />

laboratories send isolates of S. pneumoniae from cases of IPD, that is blood, CSF and<br />

isolates from other usually sterile sites, to ESR for serotyping and antibiotic resistance<br />

testing. It is thought that almost all isolates are sent to ESR, but this will be confirmed<br />

with laboratories in <strong>2008</strong>.<br />

In 2006, ESR received 151 isolates from children under the age of five years with IPD,<br />

and 126 (83.44%) of these were serotypes found in the seven-valent conjugate vaccine<br />

(PCV7).<br />

36 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


New Zealand <strong>Health</strong> Information Service data on hospitalisations<br />

Information is also available from the New Zealand <strong>Health</strong> Information Service (NZHIS)<br />

on hospitalisations for pneumococcal infections associated with meningitis and<br />

septicaemia. However, this information is likely to underestimate the burden of disease<br />

caused by IPD infection because of how the illness is coded on discharge.<br />

From the NZHIS data, Figure 5.2 shows the number of cases from 1999 to 2006<br />

hospitalised with pneumococcal meningitis in children under the age of two years, and<br />

Figure 5.3 shows the number of children hospitalised with pneumococcal septicaemia.<br />

Figure 5.2: Hospitalisations from pneumococcal meningitis in children under two years of age,<br />

1999–2006<br />

Number of cases<br />

40<br />

35<br />

30<br />

25<br />

20<br />

15<br />

10<br />

5<br />

0<br />

1999/00 2000/01 2001/2 2002/3 2003/4 2004/5 2005/6<br />

Year<br />

under 12 months<br />

12–23 months<br />

Source: NZHIS.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 37


Figure 5.3: Hospitalisations from pneumococcal septicaemia in children under two years of<br />

age, 1999–2006<br />

16<br />

14<br />

12<br />

Number<br />

10<br />

8<br />

6<br />

4<br />

2<br />

0<br />

1999/00 2000/01 2001/2 2002/3 2003/4 2004/5 2005/6<br />

Year<br />

septicaemia under 12 months<br />

septicaemia 12–23 months<br />

Source: NZHIS.<br />

New Zealand Paediatric Surveillance Unit study<br />

A two-year study took place, from May 2005 until April 2007, through the New Zealand<br />

Paediatric Surveillance Unit to monitor the number of children under 15 years of age<br />

diagnosed with pneumococcal meningitis (Lennon and Webb 2007).<br />

During the study period, 38 children were identified who fitted the case definition of<br />

confirmed pneumococcal meningitis with either a bacterial culture (34 cases) or PCR<br />

analysis (four cases), a national incidence rate of 2.2 cases per 100,000 per year in<br />

children under the age of 15 years.<br />

Of the 38 children with confirmed pneumococcal meningitis:<br />

• 28 (73.7%) were males<br />

• 33 (86.8%) were children under 24 months of age, an age-specific rate of 15.7 cases<br />

per 100,000 per year in children under the age of two years<br />

• 28 (73.7%) came from the four DHBs of: Auckland, Counties Manukau, Capital and<br />

Coast, and Canterbury<br />

• four died from pneumococcal meningitis, a case fatality rate of 10.5%<br />

• six (17.6%) suffered from a persisting neurodisability.<br />

38 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


Of the 33 children under the age of two years with pneumococcal meningitis:<br />

• 10 were babies aged 0–6 months<br />

• 13 were infants aged 6–11 months<br />

• 10 were young children aged 12–23 months<br />

• 13 were Māori; an annual Māori age-specific rate of 23.6 per 100,000 per year<br />

• seven were Pacific children; an age and ethnicity specific rate of 39.2 per 100,000<br />

year<br />

• 13 were of other ethnicities; a rate of 13.6 per 100,000 per year.<br />

Hearing impairment following pneumococcal meningitis was reported in nine children<br />

out of the 30 where audiology results were available.<br />

The serotype of S. pneumoniae was identified for 31 of 34 culture positive cases. Of<br />

these, 25 of 31 (80.6%) were of the serotypes contained in the PCV7 vaccine.<br />

Information on antimicrobial sensitivity was available for the culture positive cases, and<br />

of these, eight isolates showed reduced penicillin susceptibility, (Minimum Inhibitory<br />

Concentration (MIC) to penicillin ≥ 0.06 mg/L). In addition, four of the isolates with<br />

reduced penicillin susceptibility also demonstrated reduced susceptibility to third<br />

generation cephalosporins (MIC ≥ 0.5 mg/L).<br />

Monitoring the effect of PCV7 vaccine<br />

Following introduction of PCV7 vaccine onto the New Zealand Childhood <strong>Immunisation</strong><br />

<strong>Schedule</strong>, ongoing monitoring of IPD in all age groups will be essential to monitor for<br />

changes in disease serotypes and antimicrobial sensitivity.<br />

It is expected that IPD will be added to the list of infectious diseases to be notified by<br />

medical practitioners and by laboratories before the vaccine programme starts in June<br />

<strong>2008</strong>.<br />

5.4 Effects of introducing pneumococcal vaccine onto the infant<br />

immunisation programme<br />

Pneumococcal conjugate vaccine has been included on the immunisation schedules of<br />

over 14 countries, including the United States, the United Kingdom, Canada and<br />

Australia.<br />

Decline in severe pneumococcal disease incidence in young children and effect<br />

on invasive pneumococcal disease rates in older age groups<br />

Introduction of PCV7 vaccine to the United States infant immunisation schedule has<br />

resulted in a decline in severe pneumococcal disease incidence in young children and a<br />

decline in invasive pneumococcal disease (IPD) in unimmunised adults.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 39


Figure 5.4: Rate of vaccine-type (VT) invasive pneumococcal disease (IPD) before and after<br />

introduction of pneumococcal conjugate vaccine (PCV7), by age group and year;<br />

Active Bacterial Core surveillance, United States, 1998–2003<br />

Source: http://www.cdc.gov/mmwr/PDF/wk/mm5436.pdf<br />

Notes:<br />

* Per 100,000 population.<br />

† For each age group, the decrease in VT IPD rate for 2003 compared with the 1998–1999 baseline is<br />

statistically significant (p


Follow-up reports from the United States Centers for Disease Control and Prevention<br />

(CDC) Active Bacterial Core surveillance estimated that, in 2005, the rates of IPD were<br />

77% lower in children aged under five years compared with 1998/99. This means there<br />

were 13,000 fewer cases of IPD during 2005 (Reingold et al <strong>2008</strong>). Since the vaccine’s<br />

introduction, there has been a shift in IPD serotypes in children aged under five years,<br />

with only 7% of disease caused by PCV7 serotypes in 2005 compared with 80% during<br />

1998/99. Serotype 19A was the most common serotype causing IPD among children in<br />

2005, and the increase in non-vaccine serotypes is estimated to be small compared<br />

with the overall decrease in PCV7 serotype IPD.<br />

A review of data reports that the herd effect of immunising children aged 2–23 months<br />

resulted in decreased IPD in infants too young to be immunised or who had only<br />

received one dose (Center 2007). In those aged 0–90 days, all IPD decreased from<br />

11.8/100,000 live births to 7.2/100,000; and rates of vaccine serotype IPD decreased<br />

significantly from 7.3/100,000 live births to 2.4.100,000 (p < 0.001). In the United States<br />

prior to PCV7 introduction, IPD was higher in blacks, however, the rates are now<br />

similar, and the disparity has been reduced.<br />

In Australia, Prevenar® was introduced for Aboriginal children in 2001, and by 2004, the<br />

incidence of IPD in Aboriginal children less than two years of age was 91.5 per 100,000,<br />

compared with 219.2 cases of IPD per 100,000 children in 2001 (Center 2007).<br />

PCV7 vaccine effects on incidence of otitis media<br />

The conjugate pneumococcal vaccine is recommended to protect against IPD.<br />

However, S. pneumoniae is the most common bacterial cause of otitis media in<br />

children, and therefore, the PCV7 vaccine studies have examined whether the vaccine<br />

has any effect on the incidence of otitis media.<br />

Finnish study<br />

In a Finnish study by Eskola et al (2001), children were followed up between 6.5 and<br />

24 months of age for episodes of otitis media after receiving heptavalent pneumococcal<br />

conjugate vaccine at two, four, six and 12 months of age. It was estimated that the<br />

vaccine reduced the incidence of acute otitis media from any cause by 6% (95% CI: -4<br />

to 16%), and of culture-confirmed pneumococcal episodes by 34% (95% CI: 21 to 45%).<br />

The incidence of acute otitis media from vaccine serotypes was reduced by 57% (95%<br />

CI: 44 to 67%), and there was a 51% reduction in episodes of vaccine related/crossreactive<br />

serotype otitis media. Significant efficacy was shown against vaccine<br />

serotypes 6B, 14 and 23F, whereas efficacy against otitis caused by 19F was poorer.<br />

However, there was an increase of 33% in the number of episodes due to all other<br />

serotypes (non-vaccine and non-related serotypes).<br />

Kaiser Permanente trial<br />

Infants participating in the Kaiser Permanente PCV7 vaccine trial from 1995–1998 were<br />

followed up to 3.5 years post trial (Fireman et al 2003). The 37,868 infants enrolled in<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 41


the double blind trial received either PCV7 vaccine or a control vaccine at two, four and<br />

six months of age, plus a booster at age 12–15 months. Follow-up continued until April<br />

1999, when the study was unblended and the control group children received PCV7<br />

vaccine.<br />

The clinical records of all children were assessed for episodes of otitis media, and after<br />

adjustment of rates of otitis visits for age and season, the effect of PCV7 vaccine was<br />

assessed.<br />

Control children had an average of 1.8 otitis visits per year. Children who received<br />

PCV7 vaccine had:<br />

• a 7.8% (95% CI: 5.4 to 10.1%) reduction in otitis visits<br />

• a 5.4% reduction in antibiotic prescriptions.<br />

Overall, PCV7 vaccine reduced the risk of tympanostomy tubes by 24%.<br />

In the control group, the otitis visits peaked at age 8 to 12 months, and visits were 17%<br />

higher in boys and 50% higher in the influenza season.<br />

Recurrent otitis media<br />

A study of 383 children aged one to seven years examined whether PCV7 vaccine<br />

followed by pneumococcal polysaccharide vaccine was effective in preventing otitis<br />

media in children who had had two or more episodes of otitis media in the two years<br />

before entry to the study (Veenhoven 2003). The median length of follow-up post<br />

vaccination was 18 months.<br />

Results showed no reduction in the number of episodes of acute otitis media in the<br />

pneumococcal vaccine group compared with controls. Although the nasopharyngeal<br />

carriage of pneumococci of vaccine serotypes decreased, there was an increase in the<br />

nasopharyngeal carriage of non-vaccine serotypes.<br />

Pneumococcal conjugate vaccine is not effective in reducing otitis media in young<br />

children with a history of previous otitis media who receive vaccine at ages greater than<br />

one year.<br />

Effects of the pneumococcal conjugate vaccine on the prevention of pneumonia<br />

Streptococcus pneumoniae is a common cause of bacterial pneumonia associated with<br />

both bacteraemia-invasive pneumococcal disease and pneumonia without bacteraemia.<br />

In order to look at the effect of PCV7 on the incidence of pneumonia, following<br />

development of a WHO standard for interpretation of chest radiographs, the X-rays from<br />

children developing pneumonia who participated in the Kaiser Permanente study were<br />

reviewed (Hansen et al 2006).<br />

In this study, the efficacy of PCV7 vaccine against first-episode radiograph-confirmed<br />

pneumonia, calculated by trial radiologists, was 17.7% in the intent-to-treat group and<br />

20.5% in the per protocol (95% CI: 4.4 to 34%).<br />

42 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


Using the WHO standard, the efficacy against first-episode radiograph-confirmed<br />

pneumonia was 25.5% for the intent-to-treat group and 30.3% (95% CI: 10.7 to 45.7%)<br />

for per protocol.<br />

Serotype replacement<br />

Long-term surveillance is necessary to monitor any changes in the Streptococcus<br />

pneumoniae serotypes following introduction of conjugate pneumococcal vaccine to<br />

infants.<br />

Surveillance results suggest some serotype replacement occurs three years after the<br />

introduction of PCV7 vaccine to infants. Therefore surveillance and the development of<br />

expanded valency vaccines are important. Some of the increase in 19A and other nonvaccine<br />

serotypes (NVT) may be due to serotype switching within certain vaccine<br />

strains.<br />

Massachusetts study<br />

In Massachusetts, after PCV7 was introduced, IPD due to NVT increased from 73.7% of<br />

all cases in children under the age of five years in 2001 to 90.6% in 2005 (Hsu et al<br />

2005).<br />

As has been noted in other studies, the number and proportion of NVT serotype 19A<br />

increased over time. In Massachusetts from 2002 to 2005, overall 19A was found in<br />

27% of all IPD in children under the age of five years but had increased in 2005 to be<br />

found in 44% of cases of IPD.<br />

However, the number of cases of IPD due to 19F, a vaccine serotype, remained stable.<br />

Examination of the 19A isolates by multilocus sequence typing (MLST) showed that the<br />

diversity of the 19A types increased over time from five MLST types in 2001/02 to<br />

11 MLST types in 2004/05. Cross protection of the vaccine 19F type for the 19A<br />

appears to be limited.<br />

From 2002 to 2004, the majority of isolates of 19A demonstrated intermediate sensitivity<br />

to penicillin and full sensitivity to ceftriaxone and amoxicillin. However, in 2005 a small<br />

number of isolates of 19A were multi-drug resistant and of a sequence type not<br />

previously identified in Massachusetts.<br />

Alaskan study<br />

A study among Alaskan native children (Singleton et al 2007) showed that in the first<br />

three years after PCV7 was introduced, the rate of IPD in children younger than two<br />

years of age fell from 403.2 per 100,000 between 1995 and 2000 to 134.3 per 100,000<br />

per year between 2001 and 2003.<br />

However, from 2001 to 2006, the rate of IPD in Alaskan native children increased to<br />

244.6 per 100,000 in children under the age of two years, an increase of 82%, mainly<br />

because of the increase in NVT.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 43


Since 2004, the NVT serotypes have increased by 140%. The NVT rate between 1995<br />

and 2000 in children under two years of age was 95 per 100,000 and 228.6 between<br />

2004 and 2006. In the same time period, disease due to the vaccine serotypes has<br />

decreased by 96%, compared with the prevaccine period.<br />

IPD due to serotype 19A was found in 28.3% of IPD in Alaskan native children under<br />

two years of age during the period 2004 to 2006. There was no increase in NVT in nonnative<br />

Alaskan children.<br />

Increase in disease was accompanied by an increase in nasopharyngeal colonisation<br />

with NVT over this time. In particular, 19A increased in all age groups from 0.5% of<br />

colonised persons in the period 1998 to 2000 to 3% in 2003 and 15% in 2004. Overall<br />

41% of all persons were colonised with Streptococcus pneumoniae in 2004.<br />

Effects of introducing PCV7 on nasopharyngeal carriage of pneumococci and<br />

disease due to antibiotic resistant serotypes<br />

In the Alaskan study discussed above, the researchers looked for any change in<br />

disease presentation with the changes to NVT disease. The illnesses among Alaskan<br />

native children due to IPD NVT replacement were similar to IPD cases before PCV7<br />

introduction, except for an increase in the proportion of hospitalised IPD, pneumonia<br />

and empyema.<br />

An increase in empyema associated particularly with serotype 1 has been reported in<br />

other studies, but this type was not found in any of the Alaskan native children under the<br />

age of two years (Singleton et al 2007).<br />

In France, after the introduction of PCV7 onto the routine infant schedule, a study<br />

examined the nasopharyngeal carriage of pneumococci in children age six to 24 months<br />

presenting with acute otitis media (AOM) (Cohen et al 2006).<br />

Over the three years of the study, the proportion of infants receiving one or more doses<br />

of PCV7 increased from 8.2% in year 1 to 61.4% in year 3. The proportion of children<br />

who had received antibiotics in the three months before enrolment in the study<br />

decreased from 51.8% in year 1 to 40.9% in year 3.<br />

Overall, pneumococcal carriage and carriage of PCV7 serotypes decreased over the<br />

three-year period by 16% (p < 0.001). However, there was an increase in non-vaccine<br />

serotypes from 9.6% in year 1 to 15.8% of children in year 3. In addition, the rates of<br />

highly penicillin resistant strains of pneumococci decreased each year from 15.4% in<br />

year 1 to 10.6% in year 2 and 6.7% in year 3.<br />

Children who had received PCV7 vaccine and had not received antibiotics in the three<br />

months before they presented with AOM had the lowest rate of penicillin resistant<br />

strains. In France, implementation of PCV7 vaccine together with a planned reduction<br />

in antibiotic use had an impact of reducing the carriage of penicillin non-susceptible<br />

pneumococci.<br />

44 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


5.5 Immunogenicity and efficacy of pneumococcal conjugate<br />

vaccine<br />

See also the <strong>Immunisation</strong> Handbook 2006, chapter 16, page 316 (Ministry of <strong>Health</strong><br />

2006).<br />

Polysaccharide vaccines are poorly immunogenic in children under the age of two years<br />

because the polysaccharide antigens are T cell-independent.<br />

Covalent coupling of a polysaccharide antigen to an immunogenic protein carrier<br />

converts the polysaccharide to a T cell-dependent antigen. Conversion to a T celldependent<br />

antigen enhances the antibody response and elicits immune memory and<br />

stronger booster responses on re-exposure in infants and young children.<br />

Prevenar®, a 7-valent conjugate pneumococcal vaccine uses CRM 197 , a mutant nontoxic<br />

diphtheria toxin , as the carrier protein. Prevenar® contains the purified<br />

polysaccharides of the capsular antigens of seven Streptococcus pneumoniae<br />

serotypes (4, 9V, 14, 18C, 19F, 23F and 6B) individually conjugated to CRM 197 .<br />

The minimum titre of circulating antibody necessary for protection against IPD and otitis<br />

media has not been determined for any particular serotype. In the Kaiser Permanente<br />

trial (Black et al 2000), over 97% of PCV7 recipients achieved antibody levels of<br />

≥ 0.15 mg/mL for all serotypes after a three-dose primary series (at two, four and six<br />

months of age), and this correlated with the observed protective efficacy against IPD of<br />

97%.<br />

The serum antibody responses to some of the conjugate vaccine types are substantial<br />

after one or two doses, whereas others require completion of three doses. Three doses<br />

of conjugate vaccine in infants induced functional antibodies and a strong, rapid<br />

anamnestic response on boosting with conjugate or polysaccharide vaccine six to<br />

12 months after the primary series (<strong>National</strong> Advisory Committee on <strong>Immunisation</strong><br />

2002).<br />

Efficacy of Prevenar® in special groups<br />

Children with HIV infection<br />

Infants and young children with HIV infection are at greater risk of IPD than children<br />

without HIV infection.<br />

In a randomised controlled trial, 30 infants with HIV infection, aged 56 to 180 days at<br />

entry, received PCV7 vaccine at weeks zero, eight and 16 after enrolment, and<br />

15 infants in the control group received a placebo. Few infants were receiving<br />

antiretroviral therapy at the beginning of the study (Nachman et al 2003).<br />

The safety was monitored and the children followed until the age of two years. The<br />

vaccine was well tolerated, although more severe local reactions were seen in children<br />

who were symptomatic due to HIV infection. The PCV7 vaccine was immunogenic in all<br />

infants receiving PCV7 vaccine, although longevity of the immune response and the<br />

efficacy of the vaccine could not be measured in this small study.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 45


Low birth weight and pre-term infants<br />

In the Kaiser Permanente trial, a large randomised controlled trial of 37,868 infants,<br />

there were 1756 low birth weight (LBW) infants, under 2500 gm, including three with<br />

birth weights under 750 gm (Shinefield et al 2002). There were also 4340 pre-term<br />

infants (PT) born at gestation 32 to < 38 weeks.<br />

The LBW and PT infants were randomised and received either PCV7 or<br />

meningococcal C conjugate vaccine. The vaccine course was started at the time the<br />

infant was discharged home.<br />

In both LBW and PT infants, the PCV7 vaccine was well tolerated, safe and<br />

immunogenic.<br />

5.6 PCV7 vaccine information<br />

For further PCV7 vaccine information, refer to:<br />

• the Prevenar® data sheet (refer to the Medsafe data sheets at:<br />

http://www.medsafe.govt.nz/profs/Datasheet/dsform.asp)<br />

• the <strong>Immunisation</strong> Handbook 2006 (Ministry of <strong>Health</strong> 2006).<br />

PCV7 vaccine presentation<br />

• Pack dimensions = 150 x 110 x 50 mm (L x W x H).<br />

• Packs of 10 x 1-dose pre-filled syringes.<br />

• Needles are not supplied with the vaccine.<br />

Cold chain management<br />

• PCV7 vaccine should be stored between +2°C and +8°C.<br />

• PCV7 vaccine should not be frozen. If frozen, PCV7 vaccine should be discarded.<br />

PCV7 vaccine administration<br />

Each 0.5 mL PCV7 dose is given intramuscularly. The preferred injection sites are:<br />

• the anterolateral aspect of the thigh of infants and young children<br />

• the deltoid muscle of the upper arm of older children.<br />

Prevenar® and Infanrix®-hexa vaccines are administered in separate limbs.<br />

PCV7 vaccine efficacy<br />

See section 5.5.<br />

46 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


Expected responses and adverse events following immunisation with PCV7<br />

vaccine<br />

Local reactions (redness and swelling). In trials 10% of children had erythema after<br />

PCV7 (refer to the <strong>Immunisation</strong> Handbook 2006 page 328).<br />

Rare events (≥ 0.01% and < 0.1%) include:<br />

• febrile seizures<br />

• hypotonic, hyporesponsive episodes.<br />

Very rare events (< 0.01%) include:<br />

• urticaria<br />

• angioneurotis oedema<br />

• erythema multiforme<br />

• hypersensitivity, including anaphylaxis.<br />

Infanrix®-hexa and Prevenar®<br />

A higher incidence of fever (> 39.5°C) was reported in infants receiving Infanrix®-hexa<br />

and Prevenar® compared to infants receiving Infanrix®-hexa vaccine alone. See<br />

section 4.4 for more information.<br />

How to manage fever<br />

• Give the baby extra fluids to drink (more breastfeeds or water).<br />

• Do not overdress the baby if hot.<br />

• Paracetamol may be given for pain relief prior to immunisation.<br />

Interference with other vaccines<br />

Data on concomitant administration of Infanrix®-hexa with Prevenar® have shown no<br />

clinically relevant interference in the antibody response to each of the individual<br />

antigens when given as a three-dose primary vaccination.<br />

Avoid giving MeNZB TM vaccine at same visit as PCV7 (Prevenar®)<br />

While no problems are anticipated, either in the immune response or safety, there is no<br />

data to support giving the MeNZB TM vaccine at the same practice visit as Prevenar®.<br />

Therefore, where parents are anxious for their child to receive the MeNZB vaccine<br />

and the doctor agrees, a three-dose course of the MeNZB vaccine could start at six<br />

months of age (doses six weeks apart).<br />

See section 2.4 for more information on the eligibility for the MeNZB vaccine from<br />

1 June <strong>2008</strong>.<br />

PCV7 vaccine contraindications<br />

Contraindications include:<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 47


• hypersensitivity to any component of the PCV7 vaccine, including diphtheria toxoid<br />

• allergic reaction or anaphylactoid reaction following prior administration of PCV7<br />

vaccine.<br />

5.7 PCV7 vaccine and the <strong>National</strong> <strong>Immunisation</strong> Register – <strong>National</strong><br />

<strong>Immunisation</strong> <strong>Schedule</strong> only<br />

From 1 June <strong>2008</strong>, the NIR will record PCV7 vaccine events as part of the <strong>National</strong><br />

<strong>Immunisation</strong> <strong>Schedule</strong> for:<br />

• new babies beginning their immunisations<br />

• babies born from 1 January <strong>2008</strong> on a catch-up schedule.<br />

Note: The information above does not apply to children receiving PCV7 vaccine as part<br />

of the high-risk pneumococcal or pre/post-splenectomy programmes (see section 6 and<br />

Appendix 2). Information for the high risk pneumococcal or pre/post splenectomy<br />

programmes is recorded on the NIR as the ‘Pneumococcal’ programme.<br />

5.8 PCV7 vaccine and claiming the immunisation benefit –<br />

Childhood <strong>Immunisation</strong> <strong>Schedule</strong> only<br />

Note: The following does not apply to babies or children receiving PCV7 vaccine as part<br />

of the high-risk pneumococcal programme.<br />

• Vaccine administration date – from 1 June <strong>2008</strong>.<br />

• <strong>Immunisation</strong> benefit claims for PCV7 given as a schedule vaccine will be valid if the<br />

vaccine is administered from 1 June <strong>2008</strong>.<br />

• <strong>Immunisation</strong> benefit claims for the PCV7 as a schedule vaccine will be rejected if the<br />

vaccine is administered before 1 June <strong>2008</strong>.<br />

• <strong>Immunisation</strong> benefits for PCV7 as a schedule vaccine are valid for babies with a<br />

birth date from 1 January <strong>2008</strong>. <strong>Immunisation</strong> benefit claims for PCV7 as a schedule<br />

vaccine will be rejected if the vaccine is administered to babies with a birth date<br />

before 1 January <strong>2008</strong>.<br />

48 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


6 Expansion of the High Risk Pneumococcal<br />

Programme for Children under Five Years of Age<br />

with a Chronic Condition<br />

6.1 Addition of new eligible groups<br />

From 1 June <strong>2008</strong>, the high-risk pneumococcal programme will be expanded to include<br />

funding for children under five years with the following chronic conditions:<br />

• pre-term infants, born at under 28 weeks gestation<br />

• chronic pulmonary disease<br />

• cardiac disease with cyanosis or failure<br />

• insulin dependant diabetes<br />

• Down’s syndrome.<br />

Table 6.1 below shows the eligibility criteria for the high-risk pneumococcal programme<br />

for children under five years of age from 1 June <strong>2008</strong>.<br />

Table 6.1: Eligibility criteria for high-risk pneumococcal programme<br />

Children aged under five years with the following conditions:<br />

On immunosuppressive or radiation<br />

therapy<br />

Primary immune deficiencies<br />

HIV<br />

Renal failure or nephrotic syndrome<br />

Organ transplants<br />

Cochlear implants or intracranial<br />

shunts<br />

With chronic CSF leaks<br />

On corticosteroid therapy for more than two weeks, at daily<br />

dose of prednisone of 2 mg/kg or greater, or a total daily<br />

dosage of 20 mg or more<br />

Children pre or post splenectomy or with functional asplenia*<br />

Pre-term infants, born at under 28 weeks’ gestation<br />

Chronic pulmonary disease (including asthma treated with<br />

high-dose corticosteroid therapy)<br />

Cardiac disease with cyanosis or failure<br />

Insulin dependent diabetes<br />

Down’s syndrome<br />

* See Appendix 2 – Pre/post Splenectomy <strong>Immunisation</strong> Programme.<br />

Note: See bold text for the additional funded chronic conditions from 1 June <strong>2008</strong>.<br />

6.2 High risk pneumococcal programme immunisation schedule<br />

Children who meet the criteria are eligible for:<br />

• PCV7 (pneumococcal conjugate, Prevenar®) vaccine<br />

• 23PPV (pneumococcal polysaccharide, Pneumovax®23) vaccine.<br />

See Table 6.2 below (reproduced from the <strong>Immunisation</strong> Handbook 2006: Table 16.6,<br />

page 325; Ministry of <strong>Health</strong> 2006) for the high-risk pneumococcal programme<br />

immunisation schedule.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 49


Table 6.2: <strong>Schedule</strong> for pneumococcal vaccines for children at higher risk of pneumococcal<br />

disease with no prior history of pneumococcal vaccines<br />

Age of child at start<br />

of course<br />

Conjugate pneumococcal vaccine<br />

(PCV7)<br />

Polysaccharide pneumococcal<br />

vaccine (23PPV)<br />

6 weeks to 6 months Three doses PCV7 at least 6–8 weeks<br />

apart, or at same time as the usual<br />

schedule; plus a fourth dose at age<br />

15 months<br />

7–11 months Two doses of PCV7 at least 6–8<br />

weeks apart; plus a third dose at age<br />

15 months<br />

12–59 months Two doses of PCV7 given at 6–8<br />

weeks apart<br />

One dose of 23PPV at age 2 years<br />

and a second dose at age 4–5 years<br />

One dose of 23PPV at age 2 years<br />

and a second dose at age 4–5 years<br />

One dose of 23PPV at age 2 years<br />

and a second dose at age 4–5 years<br />

Older children up to<br />

the age of 16 years<br />

in high risk groups*<br />

One dose of PCV7<br />

One dose of 23PPV 6–8 weeks after<br />

PCV7<br />

Note: Prevenar® is approved by Medsafe only for children up to nine years of age. If a specialist<br />

recommends Prevenar® for older children, informed consent should be obtained.<br />

Catch-up schedules for children who have already received one or more doses of<br />

pneumococcal vaccine are found in Appendix 1.<br />

For children pre or post splenectomy or with functional asplenia, see Appendix 2:<br />

Pre/post Splenectomy <strong>Immunisation</strong> Programme, and for vaccine dosage, see the<br />

<strong>Immunisation</strong> Handbook 2006: Table 16.5, page 323 (Ministry of <strong>Health</strong> 2006).<br />

6.3 Entering high-risk pneumococcal programme vaccines on the<br />

<strong>National</strong> <strong>Immunisation</strong> Register<br />

Children born prior to 1 January <strong>2008</strong><br />

Children born prior to 1 January <strong>2008</strong> and identified as meeting the eligibility criteria for<br />

the high-risk pneumococcal programme (see table 6.1) will continue to have their<br />

pneumococcal vaccines (PCV7 and 23PPV) entered onto the NIR using the<br />

pneumococcal programme.<br />

Children born between 1 January <strong>2008</strong> and 31 May <strong>2008</strong><br />

Children born between 1 January <strong>2008</strong> and 31 May <strong>2008</strong> who have commenced the<br />

high-risk pneumococcal programme would have already been entered on the NIR as<br />

part of the pneumococcal programme (PI).<br />

From 1 June <strong>2008</strong>, these high-risk children will automatically transfer to the NIR<br />

Childhood <strong>Schedule</strong> (CI) and their remaining PCV7 doses will recorded as part of this<br />

CI schedule.<br />

50 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


When the high-risk child turns two years old and receives 23PPV vaccine, the PI<br />

programme takes over for these children (on the basis of the NIR receiving a 23PPV<br />

vaccine, an indicator of high risk).<br />

Children born from 1 June <strong>2008</strong><br />

PCV7 is included on the <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> from 1 June <strong>2008</strong> for all<br />

children. PCV7 doses given to high-risk children born from 1 June <strong>2008</strong> will be recorded<br />

on the CI schedule of the NIR. When the high-risk child turns two years old and receives<br />

23PPV vaccine, the PI programme takes over for these children (on the basis of the NIR<br />

receiving a 23PPV vaccine, an indicator of high risk).<br />

6.4 Claiming for high-risk pneumococcal programme vaccines<br />

The immunisation benefit can be claimed for vaccines given as part of the high-risk<br />

pneumococcal programme for children under five years of age with a chronic condition.<br />

Claim using the codes as follows.<br />

• Vaccine 100 (PCV7) and indication 12 (at risk, no previous history), 13 (at risk,<br />

previous PCV7) or 14 (at risk, previous 23 PPV).<br />

• Or, if the PCV7 vaccine is given at six weeks, three or five months as part of the<br />

usual <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> you may claim as a usual schedule vaccine,<br />

and when the child receives a dose of 23 PPV vaccine please claim under the high<br />

risk pneumococcal programme.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 51


Appendix 1: <strong>Immunisation</strong> Catch-up <strong>Schedule</strong>s<br />

The following tables are for use from 1 June <strong>2008</strong>. These tables replace Appendix 2 of<br />

the <strong>Immunisation</strong> Handbook 2006 (Ministry of <strong>Health</strong> 2006).<br />

1.1 <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong> catch-up schedules<br />

Note: PCV7 is available from 1 June <strong>2008</strong> only for healthy infants born after 1 January<br />

<strong>2008</strong>. See Section 2.2 below for catch-up schedules for infants with chronic medical<br />

conditions who are eligible for funded pneumococcal vaccines.<br />

First dose at 3–5 months<br />

First dose DTaP-IPV-HepB/Hib PCV7<br />

6 week interval DTaP-IPV-HepB/Hib PCV7<br />

6 week interval DTaP-IPV-HepB/Hib PCV7<br />

At age 15 months Hib PCV7 MMR<br />

At age 4 years DTaP-IPV MMR<br />

At age 11 years<br />

dTap<br />

First dose at age 6 months<br />

First dose DtaP-IPV-HepB/Hib PCV7<br />

6 week interval DtaP-IPV-HepB/Hib PCV7<br />

6 week interval DtaP-IPV-HepB/Hib PCV7<br />

At age 15 months Hib PCV7 MMR<br />

At age 4 years DtaP-IPV MMR<br />

At age 11 years<br />

dTap<br />

First dose at 7–11 months<br />

First dose DTaP-IPV-HepB/Hib PCV7<br />

6 week interval DTaP-IPV-HepB/Hib PCV7<br />

6 week interval DTaP-IPV-HepB/Hib<br />

At age 15 months* Hib PCV7 MMR<br />

At age 4 years DTaP-IPV MMR<br />

At age 11 years<br />

dTap<br />

* The fourth dose of Hib vaccine and the third dose of PCV7 should be two months after the prior dose.<br />

However, this should not delay the administration of MMR at 15 months. If the third dose of Hib<br />

vaccine is given at 15 months or older the fourth dose can be omitted.<br />

52 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


First dose at 12–14 months<br />

First dose DTaP-IPV-HepB/Hib MMR<br />

6 week interval* DTaP-IPV-HepB/Hib HepB<br />

6 week interval* DTaP-IPV HepB<br />

At age 4 years DTaP-IPV MMR<br />

At age 11 years<br />

dTap<br />

For children born after 1 January <strong>2008</strong>, two doses of PCV7 should be given at least six<br />

weeks apart. PCV7 should be given as a third injection at a scheduled visit.<br />

* Alternatively, at the third visits, DTaP-IPV-HepB/Hib vaccine may be given.<br />

First dose at 15 months–3 years<br />

First dose DTaP-IPV-HepB/Hib MMR<br />

6 week interval DTaP-IPV HepB<br />

6 week interval DTaP-IPV HepB<br />

At age 4 years DTaP-IPV MMR<br />

At age 11 years<br />

dTap<br />

Children born after 1 January <strong>2008</strong> are eligible for funded PCV7 vaccine from 1 June<br />

<strong>2008</strong>.<br />

For children aged 15–23 months, two doses of PCV7 should be given at least six weeks<br />

apart. PCV7 should be given as a third injection at visits one and two, but can be given<br />

at an additional visit. Alternatively, at the second visit and third visits, a DTaP-IPV-<br />

HepB/Hib and a PCV7 vaccine may be given. For ease of delivery though, additional<br />

doses of hib vaccine beyond 15 months are not required.<br />

For children aged 24–35 months, one dose of PCV7 should be given as a third injection<br />

at a scheduled visit but can be given at an additional visit. Alternatively, at the second<br />

visit, DTaP-IPV-HepB/Hib and a PCV7 vaccine may be given.<br />

First dose at 4 years<br />

First dose DTaP-IPV-Hep/Hib MMR<br />

6 week interval DTaP-IPV Hep B<br />

6 week interval DTaP-IPV Hep B<br />

6 month interval DTaP-IPV MMR<br />

At age 11 years<br />

dTap<br />

Children born after 1 January <strong>2008</strong> are eligible for funded PCV7 vaccines.<br />

For children age 24–48months, one dose of PCV7 should be given as a third injection at<br />

the first visit. Alternatively, at the second visit, DTaP-IPV-HepB/Hib and a PCV7<br />

vaccine may be given.<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 53


First dose at 5–7 years<br />

First dose DTaP-IPV HepB MMR<br />

1 month interval DTaP-IPV HepB<br />

1 month interval DTaP-IPV HepB<br />

6 months interval DTaP-IPV (or Td and IPV > 7 years) MMR<br />

At age 11 years<br />

dTap<br />

First dose at 7 years and older*<br />

First dose dTap* and IPV HepB MMR<br />

1 month interval Td and IPV HepB<br />

1 month interval Td and IPV HepB MMR<br />

10 year interval dTap* and IPV<br />

* dTap may be considered for all three doses of the primary series. See note 9 below.<br />

Notes<br />

1. There is considerable flexibility in these schedules, and the recommended intervals between doses<br />

are not sacrosanct. Vaccines may be given simultaneously and/or the schedule shortened to monthly<br />

intervals if this is deemed necessary to ensure the required numbers of doses are administered.<br />

2. If the schedule is interrupted, it is not necessary to repeat prior doses; simply resume the schedule as<br />

if no dose had been missed.<br />

3. If the immunisation status of a vaccine recipient is uncertain or unknown, then the vaccine provider<br />

should err on the side of giving rather than not giving the vaccine.<br />

4. If a child attends infrequently and failure to return for future immunisation is of concern, it is prudent to<br />

administer as many antigens as possible at the first visit.<br />

5. In the catch-up schedule for children 12–14 months of age, the third hepatitis B vaccine dose may be<br />

moved to a six-month interval if the MMR dose at 15 months coincides with the third catch-up visit and<br />

three injections are not accepted.<br />

6. MMR, Hib and pertussis are given as a priority for children 15 months of age and over because these<br />

diseases pose the greatest immediate risk.<br />

7. MMR should be given either at 15 months, or if the child/adult is older than 15 months, at the first<br />

immunisation visit.<br />

8. A single dose of Hib vaccine administered at 15 months of age and over is sufficient to induce<br />

immunity.<br />

9. After the seventh birthday, Td should be used. The dTap vaccine is given at age 11 years as a<br />

booster. As at <strong>2008</strong>, dTap and dTap-IPV are licensed for distribution for booster doses only.<br />

However, there are expected to be no safety concerns to giving three doses of dTap to previously<br />

unimmunised older children and adults. Therefore, using dTap should be considered for all catch-up<br />

and adult schedules for primary and booster immunisations.<br />

54 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


1.2 High risk pneumococcal immunisation programme catch-up<br />

schedules<br />

Following are recommendations for pneumococcal vaccines for children at higher risk of<br />

pneumococcal disease who have received a dose of a pneumococcal vaccine<br />

previously.<br />

Age of child<br />

Previous dose(s) of any<br />

pneumococcal vaccine<br />

Recommendations<br />

23 months or<br />

under<br />

Any or none As in the <strong>Immunisation</strong> Handbook 2006, chapter 16,<br />

Table 16.6, page 325 (Ministry of <strong>Health</strong> 2006)<br />

24–59 months Four doses of PCV7<br />

vaccine<br />

24–59 months 1–3 doses of PCV7<br />

vaccine<br />

One dose of 23PPV vaccine at 24 months of age, 6–8<br />

weeks after the last dose of PCV7 vaccine; and one<br />

dose of 23PPV vaccine 3–5 years after the first dose<br />

One dose of PCV7 vaccine; one dose of 23PPV<br />

vaccine 6–8 weeks after the last dose of PCV7 vaccine;<br />

and one dose of 23PPV vaccine 3–5 years after the first<br />

dose<br />

24–59 months 1 dose of 23PPV Two doses of PCV7 vaccine, 6–8 weeks apart,<br />

beginning at 6–8 weeks after the dose of 23PPV<br />

vaccine; one dose of 23PPV vaccine 3–5 years after<br />

the first dose of 23PPV vaccine<br />

24–59 months No previous dose of PCV7<br />

or 23PPV vaccine<br />

Two doses of PCV7 vaccine 6–8 weeks apart; one<br />

dose of 23PPV vaccine 6–8 weeks after the last dose of<br />

PCV7 vaccine; and one dose of 23PPV vaccine 3–5<br />

years after the first dose of 23PPV vaccine<br />

PCV7 – 7 valent-conjugate pneumococcal vaccine (Prevenar®)<br />

23 PPV – 23 valent polysaccharide pneumococcal vaccine (Pneumovax®23)<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 55


Appendix 2: Pre/Post Splenectomy <strong>Immunisation</strong><br />

Programme<br />

The following groups are eligible for the pre/post splenectomy immunisation<br />

programme:<br />

• Children (0–16 years) pre* or post splenectomy or with functional asplenia.<br />

• Adults pre* or post splenectomy.<br />

These groups are eligible for the following funded vaccines.<br />

Eligibility criteria<br />

Children (0–16 years)<br />

pre* or post<br />

splenectomy or with<br />

functional asplenia<br />

Adults pre*- or postsplenectomy<br />

Funded vaccine (trade<br />

name)<br />

PCV7 (Prevenar®)<br />

23PPV (Pneumovax®23)<br />

Meningococcal ACYW135<br />

(Menomune®)<br />

Meningococcal B<br />

(MeNZB)<br />

Hib (Hiberix)<br />

23PPV (Pneumovax®23)<br />

Meningococcal ACYW135<br />

(Menomune®)<br />

Meningococcal B<br />

(MeNZB)<br />

Hib (Hiberix)<br />

Vaccine schedule<br />

See the <strong>Immunisation</strong> Handbook 2006, Table<br />

16.5, page 323, PCV7 vaccine schedule.<br />

See the <strong>Immunisation</strong> Handbook 2006, Table<br />

16.5, page 323, 23PPV vaccine schedule.<br />

Five-yearly 23PPV boosters are also funded.<br />

One dose<br />

Five-yearly Meningococcal ACYW135 boosters<br />

are also funded if still indicated (ie, risk)<br />

If the first dose is given at age ≥ 6 months: three<br />

doses 6 weeks apart.<br />

If the first dose is given age 6 weeks to 5 months<br />

give three doses at 6 weeks apart and a fourth<br />

dose at age 10 months.<br />

One dose<br />

Five-yearly boosters are also funded<br />

One dose<br />

Five-yearly Meningococcal ACYW135 boosters<br />

are also funded if still indicated (ie, risk)<br />

Three doses 6 weeks apart<br />

One dose<br />

* Where possible the vaccines should be administered at least 14 days before splenectomy – with the<br />

exception of MeNZB, where the vaccine course should be completed at least four weeks before<br />

splenectomy.<br />

Claiming for the Pre/Post Splenectomy <strong>Immunisation</strong> Programme vaccines<br />

PCV7 should be claimed as noted in the section 6.4, that is using the codes Vaccine<br />

100 (PCV7) and indication 12 (at risk, no previous history), 13 (at risk, previous PCV7)<br />

or 14 (at risk, previous 23PPV).<br />

56 <strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet


The remaining pre/post-splenectomy vaccines should be claimed using their usual claim<br />

code (IMMB for MeNZB TM , IMOA for the others) and usual vaccine code and indication<br />

11 (pre/post-splenectomy).<br />

For more details refer to the Ministry’s Frequently Asked Questions webpage at:<br />

http://www.moh.govt.nz/moh.nsf/indexmh/healthpac-faq-immunisation<br />

<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 57


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<strong>2008</strong> <strong>National</strong> <strong>Immunisation</strong> <strong>Schedule</strong>: <strong>Health</strong> <strong>Provider</strong> Booklet 59

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