Table 2. Seroprotection/seropositivity rates at each blood sampling time point (ATP immunogenicity cohorts*).
| Study | Group | D %SP |
T %SP |
PT %S+ |
FHA %S+ |
PRN %S+ |
HBs %SP |
Polio-1 %SP |
Polio-2 %SP |
Polio-3 %SP |
Hib %SP |
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
031 n = 141 |
DTPa-HBV-IPV/Hib | Post 2 | 100 | 100 | 100 | 100 | 99.3 | 96.4 | 100 | 97.6 | 99.2 | 93.5 |
| Pre 3 | 86.4 | 96.4 | 95.7 | 100 | 86.4 | 95.7 | 94.4 | 91.9 | 80.3 | 92.8 | ||
| Post 3 | 100 | 100 | 100 | 100 | 99.3 | 98.6 | 100 | 100 | 100 | 100 | ||
|
054 n = 177 |
DTPa-HBV-IPV/Hib | Post 2 | 97.1 | 100 | 100 | 100 | 100 | 98.3 | 98.8 | 95.0 | 99.4 | 93.7 |
| Pre 3 | 84.0 | 94.4 | 98.1 | 100 | 95.5 | 96.9 | 89.3 | 84.5 | 95.3 | 90.1 | ||
| Post 3 | 100 | 100 | 100 | 100 | 100 | 98.9 | 100 | 100 | 100 | 100 | ||
|
060 n = 80 |
DTPa-HBV-IPV/Hib | Post 2 | 96.2 | 100 | 97.5 | 98.7 | 96.1 | 98.2 | 100 | 97.1 | 94.3 | 89.9 |
| Pre 3 | NT | NT | NT | NT | NT | NT | NT | NT | NT | NT | ||
| Post 3 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | ||
|
094 n = 228 |
DTPa-HBV-IPV/Hib | Post 2 | NT | NT | NT | NT | NT | 94.8 | NT | NT | NT | 88.3 |
| Pre 3 | 71.0 | 92.4 | 84.2 | 99.1 | 91.0 | 89.7 | NT | NT | NT | 79.5 | ||
| Post 3 | 100 | 100 | 100 | 100 | 98.6 | 99.1 | 99.5 | 98.5 | 97.9 | 99.1 | ||
|
014/015 n = 314 |
DTPa-HBV-IPV/Hib + MenC-TT | Post 2 | NT | NT | NT | NT | NT | 95.3 | NT | NT | NT | 95.5 |
| Pre 3 | NT | NT | NT | NT | NT | 94.2 | NT | NT | NT | 87.4 | ||
| Post 3 | NT | NT | NT | NT | NT | 99.0 | NT | NT | NT | 100 | ||
|
Esposito n = 275 |
DTPa-HBV-IPV/Hib + PCV13 | Post 2 | 92.8 | 94.2 | 99.6 | 100 | 100 | 93.8 | 99.5 | 95.6 | 99.5 | 87.0 |
| Post 3 | 100 | 97.6 | 100 | 100 | 100 | 98.4 | 100 | 100 | 100 | 99.6 | ||
| n = 279 | DTPa-HBV-IPV/Hib +PCV7 | Post 2 | 96.3 | 92.5 | 100 | 100 | 100 | 93.1 | 99.6 | 96.6 | 98.9 | 90.3 |
| Post 3 | 100 | 93.8 | 100 | 100 | 100 | 98.8 | 100 | 100 | 100 | 98.2 | ||
| Durando n = 43 | DTPa-HBV-IPV/Hib | Post 3 | 100 | 100 | NT | NT | NT | 97.7 | 100 | 100 | 100 | 100 |
| n = 151 | DTPa-HBV-IPV/Hib + PCV7 | Post 3 | 100 | 100 | NT | NT | NT | 99.3 | 100 | 100 | 100 | 100 |
N, number of subjects in ATP cohorts for immunogenicity (total vaccinated cohort for study 060). For Study 094 post-dose-2 blood samples were collected by only 2 centers for testing of anti-PRP and anti-HBs antibodies. NT, blood samples not taken at this time point in the indicated study. SP, seroprotection. For D and T ≥0.1 IU/ml, HBs ≥10 mIU/ml, poliovirus types 1, 2, 3 ≥1:8, Hib ≥0.15μg/ml. S+, seropositivity, for PT, FHA, and PRN ≥5EL.U/ml. *Analysis on the Total vaccinated cohort for study DTPa-HBV-IPV-060.