Table 3.

Anti-measles, anti-mumps, and anti-rubella seroresponse rates and geometric mean antibody concentrations at Day 42 when MMR-RIT and MMR II were administered alone (according-to-protocol cohort for immunogenicity, sub-cohort 2).

	SRR (%)
	MMR-RIT (N = 736)	MMR II (N = 283)	Difference in SRR (MMR-RIT SRR minus MMR II SRR) % (97.5% CI)a
anti-measles	100.0	99.3	0.71 (0.02, 2.97)
anti-mumps	100.0	100.0	0.00 (−0.68, 1.75)
anti-rubella	100.0	100.0	0.00 (−0.68, 1.75)
	Adjusted GMCs
	MMR-RIT (N = 729)*	MMR II (N = 280)*	Adjusted GMC ratio (MMR-RIT GMC over MMR II GMC) % (97.5% CI)b
anti-measles	3600.3	3504.3	1.03 (0.96, 1.10)
anti-mumps	167.7	174.6	0.96 (0.87, 1.06)
anti-rubella	99.3	98.6	1.01 (0.95, 1.07)

N, number of participants with both pre- and post-vaccination results available. * Except for anti-mumps, for which MMR-RIT (N = 732) and MMR II (N = 282).

SRR, seroresponse rate: percentage of participants with antibody concentration greater than or equal to the seroresponse threshold for each assay (200 mIU/mL, 10 EU/mL, and 10 IU/mL for anti-measles, anti-mumps, and anti-rubella antibodies, respectively).

Adjusted GMC, geometric mean antibody concentration adjusted for country and pre-vaccination concentration.

^aStandardized asymptotic 97.5% confidence interval.

^b97.5% confidence interval obtained using an ANCOVA model.

Bold values indicate non-inferiority criterion met. Non-inferiority criterion for SRR: lower limit of the two-sided 97.5% CI for the group difference in SRRs at D42 (MMR-RIT SRR minus MMR II SRR) ≥-5%. Non-inferiority criterion for GMCs: lower limit of the two-sided 97.5% CI for the adjusted GMC ratio at D42 (MMR-RIT GMC over MMR II GMC) ≥0.67.