Table 2.
Geometric mean concentration ratio between groups for antibodies to pertussis antigens, 1 month after primary vaccination (primary ATP cohort for immunogenicity).
| Group 1 (DTaP-HBV-IPV/Hib) |
Group 2 (DTaP-HBV-IPV + HibA) |
GMC ratio (95% CI)Group 2/Group 1 | |||
|---|---|---|---|---|---|
| Antigen | N | GMC | N | GMC | |
| PT | 146 | 43.6 | 149 | 47.9 | 1.10 (0.92–1.31) |
| FHA | 146 | 107.3 | 149 | 122.6 | 1.14 (0.97–1.35) |
| PRN | 146 | 58.2 | 149 | 46.1 | 0.79 (0.63–0.99) |
PT, pertussis toxoid; FHA, filamentous hemagglutinin; PRN, pertactin.
ATP, according-to-protocol; DTaP-HBV-IPV/Hib, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b (Hib) vaccine; DTaP-HBV-IPV, diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine; HibA, monovalent Hib conjugate vaccine; N, number of participants with available results in each group; GMC, geometric mean concentration; CI, confidence interval.
Note: Bolded values indicate that the non-inferiority criterion (upper limit of the 95% CI of the GMC ratio [Group 2 divided by Group 1] ≤ 1.5) was met.