Table 2.
Results of the inferential analyses for HBV, PHiD-CV, HRV and pertussis vaccine antigens administered as three priming doses during infancy (according to protocol immunogenicity cohort).
| Objective | Endpoint | Criteria | Antigen | Value | (95% CI) | Criterion met? |
|---|---|---|---|---|---|---|
| Primary objective | ||||||
| Non-inferiority group R vs group C | Anti-HBs ≥10mIU/ml | UL of 2-sided 95% CI for difference (HBV minus RTS,S/AS01) is <5% | HBsAg | −3.95 | (−7.12; −2.16) | Yes |
| Secondary objectives | ||||||
| Non-inferiority of group C1 over group R1 | IgG GMC ratio | UL of 2-sided 95% CI for ratio is <2 for each pneumococcal vaccine serotype | 1 | 1.15 | (0.95; 1.39) | Yes |
| 4 | 1.20 | (0.97; 1.48) | Yes | |||
| 5 | 1.27 | (1.06; 1.52) | Yes | |||
| 6B | 1.17 | (0.83; 1.65) | Yes | |||
| 7F | 1.12 | (0.94; 1.33) | Yes | |||
| 9V | 1.32 | (1.08; 1.63) | Yes | |||
| 14 | 0.99 | (0.77; 1.27) | Yes | |||
| 18C | 1.81 | (1.38; 2.38) | No | |||
| 19F | 1.21 | (0.89; 1.65) | Yes | |||
| 23F | 1.12 | (0.81; 1.55) | Yes | |||
| Non-inferiority of group C2 over group R2 | IgA GMC ratio | UL of 2-sided 95% CI for ratio is <2 | HRV | 1.11 | (0.76; 1.61) | Yes |
| Non-inferiority group R over group C | GMC ratio | UL of 2-sided 95% CI for ratio is <2 | PT | 1.08 | (0.97; 1.20) | Yes |
| FHA | 1.08 | (0.97; 1.21) | Yes | |||
| PRN | 1.10 | (0.98; 1.22) | Yes |
95% CI – 95% confidence interval; UL– upper limit of the 95% CI; GMC – geometric mean antibody concentration, RTS,S/AS01 –malaria vaccine, HBsAg – hepatitis B surface antigen, HRV – human rotavirus vaccine, PT – pertussis toxoid, FHA – filamentous haemagglutinin, PRN – pertactin, PHiD-CV – 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine.