Table 4.

Seroresponse rate and booster response rate to antibodies to the co-administered vaccines at Day 42 (according-to-protocol cohort for immunogenicity, sub-cohort 1).

	MMR-RIT		MMR II		Difference in BRR or SRR (MMR-RIT minus MMR II) % (97.5% CI)a
	N	BRR or SRR (%)	N	BRR or SRR (%)
anti-DT	659	99.7	233	100.0	−0.30 (−1.29, 1.81)
anti-FHA	659	94.1	234	94.4	−0.36 (−3.90, 4.34)
anti-PRN	660	99.5	234	99.6	−0.03 (−1.17, 2.44)
anti-PT	659	97.6	233	96.6	1.01 (−1.54, 4.95)
anti-TT	661	93.9	234	95.7	−1.78 (−5.08, 2.60)
anti-VZV	695	99.7	247	100.0	−0.29 (−1.22, 1.71)

N, number of participants with both pre- and post-vaccination results available (except for anti-VZV, which also includes participants without pre-vaccination results available); DT, diphtheria toxoid; FHA, filamentous hemagglutinin; PRN, pertactin; PT, pertussis toxoid; TT, tetanus toxoid, VZV, varicella zoster virus.

BRR, booster response rate (for anti-DT, -FHA, -PRN, -PT, and -TT antibodies): percentage of participants with a booster response for DT, TT, FHA, PRN, or PT antigens (see definitions of booster response in Patients and Methods).

SRR, seroresponse rate (for anti-VZV only): percentage of participants with antibody concentration above the seroresponse threshold (≥75 mIU/mL).

^aStandardized asymptotic 97.5% confidence interval.

Bold values indicate non-inferiority criterion met. Non-inferiority criteria: lower limit of the two-sided 97.5% CI for the group difference in BRRs or SRRs at D42 (MMR-RIT minus MMR II) ≥-10% for DT, TT, PT, FHA, and PRN antigens and ≥-5% for anti-VZV antibodies.