Table 2.

Summary of response rates and geometric mean concentrations (GMCs) after dose-1.

		MMRVAMP (N = 698)		MMRV (N = 702)
Antibody	Parameter	n	Result	n	Result	Risk Difference† / GMT Ratio‡(95% CI)
Measles	% ≥255 mIU/mL	629	96.7%	621	98.9%	−2.2 (−4.0, −0.6)
	GMC		3426.5		3719.5	0.9 (0.8, 1.0)
Mumps	% ≥10 mumps Ab units/mL	618	98.2%	610	97.2%	1.0 (−0.7, 2.8)
	GMC		112.1		114.0	1.0 (0.9, 1.1)
Rubella	% ≥10 IU/mL	608	98.8%	593	99.3%	−0.5 (−1.8, 0.7)
	GMC		81.8		80.7	1.0 (0.9, 1.1)
VZV	% ≥5 gpELISA units/mL	586	97.3%	589	93.0%	4.2 (1.8, 6.8)
	GMC		17.3		14.4	1.2 (1.1, 1.3)

^†The 2-sided 95% CI is calculated using the Miettinen and Nurminen unconditional asymptotic method. The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the pre-specified criterion (5.0 percentage points for measles, mumps, and rubella or 10.0 percentage points for VZV). This indicates that the difference is statistically significantly less than the pre-specified clinically relevant decrease of 5.0 or 10.0 percentage points in proportions at the 1-sided α = 0.025 level.

^‡The 2-sided 95% CI is based on the natural log-transformed titers and the t-distribution. The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on fold-difference, excluding a decrease of 1.5-fold or more. This indicates that fold difference is statistically significantly less than the pre-specified clinically relevant decrease of 1.5-fold on fold difference at the 1-sided α = 0.025 level.

N = Number of subjects vaccinated in the vaccination group at Dose-1.

n = Number of subjects with seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.

Seronegative antibody titer - measles: <255 mIU/mL; mumps: <10 mumps Ab units/mL; rubella: <10 IU/mL; VZV: <1 .25 gpELISA units/mL.

VZV = varicella-zoster virus.

CI = Confidence interval.