Table 2.
Non-inferiority of MMR-RIT vaccine compared to MMR II in terms of anti-measles, anti-mumps and anti-rubella adjusted geometric mean antibody concentrations at Day 42 (ATP cohort for immunogenicity).
| Adjusted GMC |
|||
|---|---|---|---|
| Antibody | MMR-RIT (N = 432) | MMR II (N = 435) | Adjusted GMC ratio (MMR-RIT GMC/MMR II GMC) Ratio (95% CI) |
| Anti-measles (mIU/mL) | 1790.2 | 1781.5 | 1.00 (0.91, 1.11) |
| Anti-mumps (EU/mL) | 113.5 | 107.8 | 1.05 (0.96, 1.16) |
| Anti-rubella (IU/mL) | 76.1 | 74.6 | 1.02 (0.93, 1.11) |
ATP, according-to-protocol; GMC, geometric mean concentration; N, number of participants with both pre- and post-vaccination results available; CI, confidence interval.
The two-sided 95% CI for the adjusted GMC ratio was obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group as fixed effect, gender, age and country groups as continuous effects, and the pre-vaccination log-transformed concentration as regressor.
Bolded values indicate lower limit of the two-sided 95% confidence interval ≥0.67 (i.e., criterion for non-inferiority of MMR-RIT over MMR II in terms of GMCs).