Table 4.
Geometric Mean Concentrations (GMCs) for Varicella-Zoster Virus (VZV) Antibodies, and Baseline-Adjusted GMCs and GMC Ratios for Antibodies to Hepatitis A Virus and PCV7 Pneumococcal Serotypes at Day 42 (According-to-Protocol Cohort for Immunogenicity)
| Antibody | MMRII |
MMR-RIT-1 |
MMR-RIT-2 |
MMR-RIT-3 |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| N | GMC (95% CI) | N | GMC (95% CI) | N | GMC (95% CI) | N | GMC (95% CI) | ||||
| VZV | 246 | 256 (240; 272) | 245 | 246 (229; 263) | 238 | 235 (217; 254) | 240 | 256 (240; 272) | |||
| MMRII |
MMR-RIT-1 |
MMR-RIT-2 |
MMR-RIT-3 |
||||||||
| N | Adjusted GMC | N | Adjusted GMC | Adjusted GMC ratioa (95% CI) | N | Adjusted GMC | Adjusted GMC ratioa (95% CI) | N | Adjusted GMC | Adjusted GMC ratioa (95% CI) | |
| Hepatitis A virus | 124 | 42.0 | 117 | 33.9 | 0.81 (0.64; 1.02) | 112 | 39.2 | 0.93 (0.74; 1.18) | 111 | 39.5 | 0.94 (0.74; 1.19) |
| S.PNEU-4 | 116 | 3.68 | 122 | 3.69 | 1.00 (0.82; 1.24) | 125 | 3.78 | 1.03 (0.84; 1.26) | 124 | 3.26 | 0.89 (0.72; 1.09) |
| S.PNEU-6B | 111 | 6.50 | 117 | 5.86 | 0.90 (0.75; 1.09) | 122 | 5.87 | 0.90 (0.75; 1.09) | 123 | 5.81 | 0.89 (0.74; 1.07) |
| S.PNEU-9V | 120 | 7.32 | 121 | 6.65 | 0.91 (0.76; 1.08) | 125 | 7.23 | 0.99 (0.83; 1.17) | 127 | 5.80 | 0.79 (0.64; 0.94) |
| S.PNEU-14 | 118 | 7.87 | 127 | 8.91 | 1.13 (0.95; 1.35) | 127 | 8.29 | 1.05 (0.88; 1.26) | 126 | 7.89 | 1.00 (0.84; 1.20) |
| S.PNEU-18C | 119 | 6.58 | 123 | 6.29 | 0.96 (0.79; 1.15) | 126 | 6.62 | 1.01 (0.84; 1.21) | 126 | 5.98 | 0.91 (0.76; 1.09) |
| S.PNEU-19F | 115 | 2.39 | 122 | 2.41 | 1.01 (0.83; 1.22) | 126 | 2.52 | 1.05 (0.87; 1.27) | 126 | 2.33 | 0.97 (0.80; 1.18) |
| S.PNEU-23F | 113 | 10.21 | 121 | 9.56 | 0.94 (0.76; 1.16) | 127 | 9.69 | 0.95 (0.77; 1.17) | 126 | 8.37 | 0.82 (0.67; 1.01) |
Abbreviations: Adjusted GMC, geometric mean antibody concentration adjusted for baseline antibody concentration; MMR, measles-mumps-rubella; N, Number of subjects with both pre- and post-vaccination results available; 95% CI, 95% confidence interval for the adjusted GMC ratio (ANCOVA model: adjustment for baseline concentration - pooled variance with more than 2 groups); S.PNEU, Streptococcus pneumoniae.
aRatio of MMR-RIT lot: MMRII.