Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro®) and a varicella vaccine (VARIVAX®) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial

Table 3 Response rates to measles, mumps, rubella and varicella at 42 days post vaccination for children initially seronegative to measles, mumps, rubella or varicella in the antigen-specific per-protocol sets

	IM Group N= 374¹		SC Group N= 378¹		Difference (%)³ IM group – SC group [95% CI]
	n ²	Response rate n(%)⁴ [95% CI]	n ²	Response rate n(%)⁴ [95% CI]
Measles (≥ 255 mIU/Ml)	349	329 (94.3) [91.3; 96.5]	363	349 (96.1) [93.6; 97.9]	-1.89 [-5.28; 1.29]
Mumps (≥ 10 ELISA Ab units/ml)	349	341 (97.7) [95.5; 99.0]	363	356 (98.1) [96.1; 99.2]	-0.33 [-2.67; 2.00]
Rubella (≥ 10 IU/ml)	321	315 (98.1) [96.0; 99.3]	318	312 (98.1) [95.9; 99.3]	-0.02 [-2.42; 2.43]
Varicella (≥ 5 gpELISA units/ml)	336	297 (88.4) [84.5; 91.6]	345	295 (85.5) [81.3; 89.0]	2.93 [-2.18; 8.06]

(IM group, both vaccines administered by the intramuscular route; SC group, both vaccines administered by the subcutaneous route; ELISA, enzyme-linked immunosorbent assay; Ab, antibody; gpELISA, glycoprotein antigen-based enzyme-linked immunosorbent assay.)
¹Number of vaccinated subjects
²Number of subjects initially seronegative to measles (<255 mIU/ml), mumps (<10 ELISA Ab units/ml), rubella (<10 IU/ml) or varicella (<1.25 gpELISA units/ml) contributing to each per-protocol set
³Stratified by region
⁴Number and percentage of subjects

ISSN: 1741-7015