Table 1. Number of Subjects in Relevant Study Cohorts.
| |
Total |
|
Australian Study |
|
US Immunogenicity Cohorta |
|
Pooled |
|||
|---|---|---|---|---|---|---|---|---|---|---|
| Group | HibMenCY-TT | Hib-OMP | HibMenCY-TT | Hib-OMP | HibMenCY-TT | Hib-OMP | ||||
|
Enrolled in the fourth dose phase |
1648 |
|
626 |
206 |
|
618 |
198 |
|
1244 |
404 |
|
Fourth dose total vaccinated cohort |
1645 |
|
625 |
204 |
|
618 |
198 |
|
1243 |
402 |
|
Reasons for exclusion from ATP cohort: |
|
|
|
|
|
|
|
|
|
|
| Administration of forbidden vaccine |
|
|
0 |
0 |
|
4 |
0 |
|
4 |
0 |
| Study vaccine dose administered contrary to protocol |
|
|
11 |
2 |
|
54 |
13 |
|
65 |
15 |
| Ineligibility for persistence analysisb |
|
|
0 |
0 |
|
46 |
8 |
|
46 |
8 |
| Essential safety data missing |
|
|
11 |
4 |
|
0 |
0 |
|
11 |
4 |
| Inappropriate age at fourth dose |
|
|
3 |
0 |
|
1 |
0 |
|
4 |
0 |
| Administration of forbidden medication |
|
|
0 |
0 |
|
1 |
0 |
|
1 |
0 |
| Infection related to vaccinec |
|
|
0 |
0 |
|
1 |
0 |
|
1 |
0 |
| Noncompliance with blood sampling schedule |
|
|
28 |
5 |
|
49 |
23 |
|
77 |
28 |
| Essential serological data missing |
|
|
17 |
11 |
|
72 |
22 |
|
89 |
33 |
| Data errord |
|
|
1 |
0 |
|
1 |
0 |
|
2 |
0 |
| Fourth dose ATP cohort for immunogenicity | 1257 | 554 | 182 | 389 | 132 | 943 | 314 | |||
a For the US cohort, pneumococcal conjugate vaccine (Prevnar™, Pfizer Inc.) was a concomitant vaccine, in accordance with local recommendations.
b Subjects excluded from according-to-protocol cohort for immunogenicity (primary phase) unless reason for exclusion was noncompliance with protocol-defined serum sampling windows or lack of availability of immunogenicity results at post-dose 3 time point.
c One subject in the HibMenCY-TT group developed varicella infection before administration of varicella vaccine.
d Obvious incoherence between pre- and post-fourth dose vaccination data.
Note: the number of subjects excluded for a specific reason does not take into account subjects already excluded because of reasons presented previously.