Table 3.
Non-inferiority of MMR-RIT vaccine compared to MMR II in terms of anti-measles, anti-mumps and anti-rubella seroresponse rates at Day 42 (ATP cohort for immunogenicity).
| SRR (%) |
|||
|---|---|---|---|
| Antibody (prespecified threshold) | MMR-RIT (N = 433) | MMR II (N = 436) | Difference in SRRs (MMR-RIT SRR – MMR II SRR) % (95% CI) |
| Anti-measles (≥200 mIU/mL) | 98.8 | 99.1 | -0.24 (-1.87, 1.32) |
| Anti-mumps (≥10 EU/mL) | 98.4 | 99.5 | -1.16 (-2.90, 0.23) |
| Anti-rubella (≥10 IU/mL) | 99.5 | 99.8 | -0.23 (-1.46, 0.86) |
ATP, according-to-protocol; SRR, seroresponse rate: percentage of participants with concentration equal to or above the prespecified threshold indicated for each assay; N, number of participants with available results; CI, confidence interval.
a
The standardized asymptotic 95% confidence interval was obtained using the Miettinen and Nurminen method.
Bolded values indicate lower limit of the standardized asymptotic 95% confidence interval ≥-5% (i.e., criterion for non-inferiority of MMR-RIT over MMR II in terms of SRRs).