Efficacy of a pentavalent rotavirus vaccine in reducing rotavirus-associated health care utilization across three regions (11 countries)

SummaryObjectiveTo evaluate the effect of a human-bovine reassortant pentavalent rotavirus vaccine (PRV) on health care encounters in nearly 70 000 subjects randomized in three regions – Europe, the United States, and Latin America/the Caribbean – in the Rotavirus Efficacy and Safety Trial (REST).MethodsHealthy 6- to 12-week-old infants received 3 doses of PRV or placebo at 4- to 10-week intervals. The exact binomial method for ratios of Poisson counts was used to evaluate the effect of PRV on the rate of rotavirus-related hospitalizations and emergency department (ED) visits involving rotavirus G-types 1–4 occurring ≥14 days after the third dose of vaccine for up to 2 years.ResultsIn fully vaccinated infants, reductions in rotavirus-associated hospitalizations and ED visits were 94.7% (95% CI: 90.9, 96.9) in Europe, 94.9% (95% CI: 84.0, 98.9) in the United States, and 90.0% (95% CI: 29.4, 99.8) in the Latin American/Caribbean regions.ConclusionsPRV reduced hospitalizations and ED visits within each region in REST. Results were consistent across regions and across the overall study cohort.