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

Objective: To 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). Methods: Healthy 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. Results: In fully vaccinated infants, reductions in rotavirus-associated hospitalizations and ED visits were 94.7% (95% Cl: 90.9, 96.9) in Europe, 94.9% (95% Cl: 84.0, 98.9) in the United States, and 90.0% (95% Cl: 29.4, 99.8) in the Latin American/Caribbean regions. Conclusions: PRV reduced hospitalizations and ED visits within each region in REST Results were consistent across regions and across the overall study cohort. (c) 2007 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.