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LIVE POLIO IRUS VACCINES

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344<br />

Efficacy-Laboratory Evidence<br />

tion. There could therefore be no bias in the<br />

clinical interpretation of symptoms that were<br />

reported.<br />

Two blood specimens drawn at about 80-day<br />

intervals as shown in Table 2 were collected from<br />

each participant. These were sent to the laboratory<br />

with a label that identified their origin and<br />

sequence by code number. The specimens in<br />

any one pair were always tested on the same day<br />

in the same run. But, when these pairs were<br />

actually tested, the original identifying labels had<br />

been replaced by a scrambled and random numbering<br />

system that made it impossible for the<br />

testing personnel to identify any one specimen as<br />

to its individual origin, its set origin, or its<br />

sequence within any one given set.<br />

Two public health nurses were employed to<br />

offer a generalized public health nursing service<br />

to the participants for the duration of the<br />

study. The public health nurses visited each participant's<br />

home to complete the family and individual<br />

record forms. They assisted at bleeding<br />

TABLE 3.<br />

OCCURRENCE OF SYMPTOMS BY CLINICAL TYPE AND BY EXPERIMENTAL GROUP DURING THE<br />

CONTROL PERIOD<br />

PERIOD<br />

RESPIRATORY<br />

V<strong>IRUS</strong> PLACEBO<br />

GASTRO-INTESTINAL<br />

(DIARRHEA)<br />

V<strong>IRUS</strong> PLACEBO<br />

FEVER ALONE<br />

V<strong>IRUS</strong> PLACEBO<br />

OTHER<br />

V<strong>IRUS</strong> PLACEBO<br />

CHILDREN()<br />

2/22-2/28<br />

3/ 1*-3/7<br />

3/ 8-3/14<br />

3/15-3/21<br />

3/22-3/28<br />

3/29*-4/4<br />

4/ 5-4/11<br />

4/12-4/18<br />

4/19-4/22<br />

1<br />

2<br />

2<br />

2<br />

2<br />

2<br />

1<br />

2<br />

1 1<br />

5<br />

1(3)<br />

2(4)<br />

1 (<br />

Totals<br />

7 5<br />

6 3<br />

1 0<br />

1] 3<br />

ADULTS(2)<br />

2/22-2/28<br />

3/ 1*-3/7<br />

3/ 8-3/14<br />

3/15-3/21<br />

3/22-3/28<br />

3/29*-4/4<br />

4/ 5-4/11<br />

4/12-4/18<br />

4/19-4/22<br />

1<br />

3<br />

1<br />

1(6)<br />

1(6)<br />

Totals<br />

1 4<br />

1 0<br />

0 1<br />

2 0<br />

* Indicates feeding dates.<br />

(1) Total children in virus group, 60; total in placebo group, 51.<br />

(2) Total adults in virus group, 53; total in placebo group 55.<br />

(3) Pyelitis.<br />

(4) One rash; one case of allergy.<br />

(5) Rash.<br />

(6) Abortion.

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