Table 2. Hepatitis A, VZV, and S. pneumoniae antibody responses (per-protocol population) among study subjects.
| Parameter | Group 1 | Group 2 | Estimated risk difference or fold differencea | P valueb | |||||
|---|---|---|---|---|---|---|---|---|---|
| (Concomitant) | (Non-concomitant) | ||||||||
| n = 330 | n = 323 | ||||||||
| n | Observed response | (95% CI) | n | Observed response | (95% CI) | (95% CI) | |||
| Hepatitis A SPR and GMT at 4 weeks postdose 2 with HAV | |||||||||
| SPR (≥10 mIU/mL) | 182 | 100% | (98.0, 100) | 159 | 99.40% | (96.5, 100) | 0.7 (−1.4, 3.8) | <0.001 | |
| GMT | 182 | 4976.6 | (4067.6, 6088.6) | 159 | 6123.2 | (4825.6, 7769.7) | not calculated | ||
| VZV antibody response rate and GMT at 6 weeks postdose 1 with MMRV | |||||||||
| ≥5 gpELISA units/mL | 225 | 93.30% | (89.2, 96.2) | 232 | 98.30% | (95.6, 99.5) | −5.1 (−9.3, −1.4) | 0.013 | |
| GMT | 225 | 14.6 | (13.3, 16.1) | 232 | 16.4 | (15.1, 17.7) | not calculated | ||
| S. pneumoniae antibody responses and GMT at 6 weeks post PCV-7 | |||||||||
| Type 4 | GMT | 246 | 1.8 | (1.6, 2.1) | 247 | 1.6 | (1.4, 1.8) | 1.1 (0.9, 1.3) | <0.001 |
| Type 6B | GMT | 246 | 9.5 | (8.3, 11.1) | 246 | 9.6 | (8.5, 10.8) | 1.0 (0.8, 1.2) | <0.001 |
| Type 9V | GMT | 247 | 3.7 | (3.2, 4.2) | 247 | 4.1 | (3.7, 4.7) | 0.9 (0.8, 1.0) | <0.001 |
| Type 14 | GMT | 248 | 7.7 | (6.8, 8.8) | 247 | 7.4 | (6.5, 8.4) | 1.0 (0.9, 1.2) | <0.001 |
| Type 18C | GMT | 247 | 2.9 | (2.6, 3.3) | 247 | 2.6 | (2.3, 3.0) | 1.1 (0.9, 1.3) | <0.001 |
| Type 19F | GMT | 248 | 4 | (3.5, 4.5) | 248 | 3.8 | (3.3, 4.3) | 1.1 (0.9, 1.2) | <0.001 |
| Type 23F | GMT | 247 | 4.9 | (4.3, 5.6) | 247 | 4.5 | (3.9, 5.1) | 1.1 (1.0, 1.3) | <0.001 |
N, Number of subjects randomized and vaccinated in each group; n, Number of subjects contributing analysis; CI, Confidence interval; SPR, Seropositivity Rate; SPR, seroprotection rate; GMT, geometric mean titer; gpELISA, glycoprotein enzyme-linked immunosorbent assay; VZV, varicella-zoster virus; HAV, hepatitis A vaccine; aEstimated risk differences and fold differences were calculated based on a statistical analysis model adjusting for study center; bComputed based on a similarity (non-inferiority) test to rule out a decrease of ≥10 percentage points (for risk differences) or 2-fold (for fold-difference).