Table 2.
Noninferiority of MMR-RIT (Pooled Lots) Over MMR II in Terms of Anti-Measles, Anti-Mumps, and Anti-Rubella SRRs and Adjusted GMCs and Acceptable Immunoresponse of MMR-RIT (Pooled Lots) on Day 42 (According-to-Protocol Cohort for Immunogenicity)a
| Parameter | MMR-RITb | MMR II | Difference in SRRs (Pooled MMR-RIT SRR − MMR II SRR)c or Adjusted GMC Ratio (Pooled MMR-RIT GMC/MMR II GMC)d |
|---|---|---|---|
| SRR (% [95% CI]) | |||
| Anti-measles | 98.2 (97.6 to 98.6) | 98.0 (97.0 to 98.7) | 0.18 (−0.68 to 1.25) |
| Anti-mumps | 98.4 (97.9 to 98.8) | 97.6 (96.5 to 98.4) | 0.81 (−0.10 to 1.96) |
| Anti-rubella | 97.3 (96.7 to 97.9) | 98.5 (97.6 to 99.1) | −1.15 (−2.00 to −0.15) |
| Adjusted GMCs (95% CI) | |||
| Anti-measles | 3165.2 | 3215.4 | 0.98 (0.93 to 1.05) |
| Anti-mumps | 76.4 | 73.0 | 1.05 (0.99 to 1.11) |
| Anti-rubella | 52.5 | 60.0 | 0.87 (0.83 to 0.92) |
Abbreviations: CI, confidence interval; SRR, seroresponse rate (defined as the percentage of initially seronegative participants with a concentration above seroresponse)
aThe adjusted GMC is the geometric mean antibody concentration from an analysis of variance model on log-transformed concentrations with treatment group and country as factors; the threshold for each antibody was 200 mIU/mL for anti-measles, 10 EU/mL for anti-mumps, and 10 IU/mL for anti-rubella. The numbers of participants for whom both prevaccination and postvaccination results were available were 3248 (MMR-RIT) and 1137 (MMR II) for anti-measles, 3187 (MMR-RIT) and 1107 (MMR II) for anti-mumps, and 3245 (MMR-RIT) and 1135 (MMR II) for anti-rubella.
bAcceptable immunoresponse to MMR-RIT was demonstrated if the lower limit of the 95% CI for the SSR in the MMR-RIT group (pooled lots) was ≥90% for anti-measles, anti-mumps, and anti-rubella.
cStandardized asymptotic 95% CI.
dThe 95% CI for the adjusted GMC ratio (analysis of variance model: adjustment for country—pooled variance with >2 groups). Values in bold indicate that noninferiority criteria were met: the lower limit of the 95% CI for the difference in SRRs (pooled MMR-RIT − MMR II) was −5% or higher, and the lower limit of the 95% CI for the adjusted GMC ratio (pooled MMR-RIT/MMR II) was ≥0.67.