Table 5.
Geometric mean antibody concentrations or titers to the co-administered vaccines at Day 42 (according-to-protocol cohort for immunogenicity, sub-cohort 1).
| MMR-RIT |
MMR II |
Adjusted GMC/GMT ratio (MMR-RIT over MMR II) % (97.5% CI)a |
|||
|---|---|---|---|---|---|
| N | Adjusted GMC/GMT |
N | Adjusted GMC/GMT |
||
| anti-PV 1 (ED50) | 669 | 1636.5 | 238 | 1558.4 | 1.05 (0.88, 1.25) |
| anti-PV 2 (ED50) | 653 | 2032.7 | 233 | 2197.3 | 0.93 (0.78, 1.09) |
| anti-PV 3 (ED50) | 590 | 2794.4 | 214 | 2978.8 | 0.94 (0.77, 1.14) |
| anti-FHA (IU/mL) | 684 | 313.7 | 243 | 323.3 | 0.97 (0.88, 1.07) |
| anti-PRN (IU/mL) | 682 | 399.9 | 243 | 417.6 | 0.96 (0.84, 1.09) |
| anti-PT (IU/mL) | 684 | 76.1 | 243 | 73.0 | 1.04 (0.92, 1.18) |
| anti-VZV (mIU/mL) | 695 | 879.7 | 247 | 830.1 | 1.06 (0.95, 1.18) |
N, number of participants with available results; FHA, filamentous hemagglutinin; PRN, pertactin; PT, pertussis toxoid; PV, poliovirus; VZV, varicella zoster virus.
Adjusted GMC/GMT, geometric mean antibody concentration/titer adjusted for pre-vaccination concentration.
a97.5% confidence interval calculated with an ANCOVA model.
Bold values indicate non-inferiority criterion met. Non-inferiority criterion: lower limit of the two-sided 97.5% CI for the adjusted GMC or GMT ratio at D42 (MMR-RIT over MMR II) ≥0.67.