Table 3.
Anti-HBs seroprotection rates and geometric mean antibody titers one month post-dose 3 (ATP immunogenicity cohort).
| ≥ 6.2 mIU/ml |
≥ 10 mIU/ml |
GMT |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Group | Timing | N | n | % | (95% CI) | n | % | (95% CI) | value | (95% CI) |
| R | Screening | 398 | 83 | 20.9 | (17.0; 25.2) | 63 | 15.8 | (12.4; 19.8) | 5.0 | (4.5; 5.7) |
| Post-III | 397 | 397 | 100 | (99.1; 100) | 397 | 100 | (99.1; 100) | 6412.7 | (5732.9; 7173.0) | |
| C | Screening | 251 | 57 | 22.7 | (17.7; 28.4) | 45 | 17.9 | (13.4; 23.2) | 5.4 | (4.7; 6.4) |
| Post-III | 253 | 246 | 97.2 | (94.4; 98.9) | 243 | 96.0 | (92.9; 98.1) | 377.4 | (310.6; 458.7) | |
Group R = All study groups that received RTS,S/AS01 vaccine.
Group C = All study groups that received HBV vaccine.
N = number of subjects with available results.
GMT = geometric mean antibody titer calculated on all subjects.
n/% = number/percentage of subjects with titer ≥ specified value.
95% CI = 95% confidence interval.
Screening = Pre-vaccination, Post III = one month post-dose 3.
ATP = according to protocol.