Abstract
INTRODUCTION: In Europe, recommended administration route for vaccines and physicians' preferences vary. OBJECTIVE: The aim of this study was to compare the immunogenicity and safety profile (injection-site and systemic adverse events) of a measles-mumps-rubella vaccine (M-M-RvaxPRO) and a varicella vaccine (Varivax) when given by intramuscular or subcutaneous route. METHODS: A total of 752 healthy children who were 12 to 18 months of age were randomly assigned to receive concomitantly at 2 separate injection sites 1 dose of both vaccines by the same route, either intramuscular or subcutaneous. RESULTS: Six weeks after vaccination, response rates in patients who were initially seronegative were similar for all antigens (intramuscular noninferior to subcutaneous), and geometric mean titers were comparable irrespective of the administration route (Table 1). Similar numbers and types of systemic adverse events were observed in both groups, excepted for varicella/varicella-like rashes, which were less frequent in the intramuscular group. Injection-site reactions were also less frequent for both vaccines in the intramuscular group compared with the subcutaneous group (15.8% and 25.8% of patients for M-M-RvaxPRO and 20.9% and 34.3% for Varivax, respectively), but the safety pattern was comparable between groups. CONCLUSIONS: These results support both intramuscular and subcutaneous administration routes for M-M-RvaxPRO and Varivax. TABLE 1.Response Rates and Geometric Mean Titers of the Measles-Mumps-Rubella and Varicella Vaccines When Given by Different RoutesPer-Protocol AnalysisIntramuscularSubcutaneous n Relative Risk, %GMTs n Relative Risk, %GMTsMeasles, ≥255 mIU/mL34994.32396.436396.12560.6Mumps, ≥10 ELISA Ab U/mL34997.786.436398.189.8Rubella, ≥10 IU/mL32198.197.231898.194.4Varicella ≥5 gpELISA U/mL33688.49.834585.59.2 ≥1.25 gpELISA U/mL33698.59.834599.49.2
Published Version
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