Table 2.

Anti-measles, anti-mumps, and anti-rubella seroresponse rates and geometric mean antibody concentrations at Day 42 when MMR-RIT and MMR II were co-administered with DTaP-IPV and VV (according-to-protocol cohort for immunogenicity, sub-cohort 1).

	SRR (%)
	MMR-RIT (N = 697)*	MMR II (N = 249)*	Difference in SRR (MMR-RIT SRR minus MMR II SRR) % (97.5% CI)a
anti-measles	100	100	0.00 (−0.72, 1.98)
anti-mumps	100	100	0.00 (−0.72, 1.97)
anti-rubella	99.9	100	−0.14 (−0.98, 1.84)
	Adjusted GMCs
	MMR-RIT (N = 690)*	MMR II (N = 245)*	Adjusted GMC ratio (MMR-RIT GMC over MMR II GMC) % (97.5% CI)b
anti-measles	4285.0	4333.5	0.99 (0.92, 1.06)
anti-mumps	171.3	188.5	0.91 (0.83, 1.00)
anti-rubella	97.1	94.5	1.03 (0.97, 1.09)

N, number of participants with both pre- and post-vaccination results available. * Except for anti-mumps, for which MMR-RIT (N = 698) and MMR II (N = 250) for SRR, and MMR-RIT (N = 691) and MMR II (N = 248) for GMC.

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 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% for measles, mumps and rubella viruses. 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 for anti-measles, anti-mumps and anti-rubella antibodies.