NIMENRIXâ¢ - GlaxoSmithKline

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PART II: SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION Drug Substance NIMENRIX ® is composed of the purified capsular polysaccharides of Neisseria meningitidis serogroups A, C, W-135 and Y, each conjugated to tetanus toxoid. CLINICAL TRIALS The immunogenicity of one dose of NIMENRIX ® has been evaluated in more than 8,000 subjects aged ≥12 months. Vaccine efficacy was inferred from the demonstration of immunologic non-inferiority (based mainly on comparing proportions with rabbit complement serum bactericidal assay (rSBA) titres at least 1:8) to licensed meningococcal vaccines. Immunogenicity was measured by using rSBA or human complement serum bactericidal assay (hSBA) which are biomarkers for protective efficacy against meningococcal serogroups A, C, W-135 and Y. October 22, 2014 Page 16 of 29
Table 4 Study demographics and trial design Study # Study Objectives Trial design No. of study subjects § Mean age in Years (Range) 12-23 months Men ACWY-TT -039 Men ACWY-TT -081 Men ACWY-TT -035 Men ACWY-TT -071 Men ACWY-TT -071 Immunogenicity and safety compared to Meningococcal C-CRM 197 conjugate (MenC-CRM) vaccine and concomitant administration with measles-mumps-rubellavaricella vaccine (MMRV) Immunogenicity and safety compared to MenC-CRM Lot-to-lot consistency; immunogenicity and safety compared to ACWY-PS and concomitant administration with influenza virus vaccine Immunogenicity and safety compared to quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MENACTRA ® ) Immunogenicity and safety compared to quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MENACTRA ® ) Men Immunogenicity, safety, ACWY-TT- and reactogenicity 085 compared to ACWY-PS Open, randomized, controlled, multicentre 2-10 years Open, randomized, controlled, multicentre 10-55 years Partially doubleblinded, randomized, controlled, multicentre Observer-blinded, randomized, controlled, multicentre Observer-blinded, randomized, controlled, multicentre > 55 years Open, randomized, controlled Total=972 NIMENRIX ® =366 Co-admin =361 MMRV=121 MenC-CRM =124 Total=395 NIMENRIX ® =296 MenC-CRM =99 Total=1284 NIMENRIX ® =885 ACWY-PS=294 Co-admin=105 Total =951 NIMENRIX ® =637 MENACTRA ® =314 Total =951 NIMENRIX ® =637 MENACTRA ® =314 Total = 260 NIMENRIX ® = 194 ACWY-PS= 66 § Number of subjects in according-to-protocol (ATP) cohort for immunogenicity or persistence 14.6 months (12-19 months) 5.6 (2-10) 35.5 (18-55) 16.3 (10-25) 16.3 (10-25) 63.9 (56-103) Gender Male/ Female 507/465 191/204 710/574 464/487 464/487 178/82 Study results Immunogenicity in toddlers aged 12-23 months In the clinical study MenACWY-TT-039, the immune response to vaccination with either NIMENRIX ® or a licensed meningococcal C-CRM 197 conjugate (MenC-CRM) vaccine was evaluated. October 22, 2014 Page 17 of 29
Page 1 and 2: PRODUCT MONOGRAPH NIMENRIX ® Menin
Page 3 and 4: NIMENRIX ® Meningococcal polysacch
Page 5 and 6: Febrile Illness As with other vacci
Page 7 and 8: Table 1 Study MenACWY-TT-039: Perce
Page 9 and 10: Adolescents aged 10-25 years In Stu
Page 11 and 12: Post-Market Adverse Drug Reactions
Page 13 and 14: when measured by assays using eithe
Page 15: Composition After reconstitution, 1
Page 19 and 20: Table 6 Study MenACWY-TT-081: Perce
Page 21 and 22: The response to the four meningococ
Page 23 and 24: Table 9 Immune response (rSBA) 1 mo
Page 25 and 26: REFERENCES 1. Baxter, R., Baine, Y.
Page 27 and 28: IMPORTANT: PLEASE READ PART III: CO
Page 29: IMPORTANT: PLEASE READ MORE INFORMA

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