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% 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. Conclusions: PRV reduced hospitalizations and ED visits within each region in REST. Results were consistent across regions and across the overall study cohort. © 2007 International Society of Infectious Diseases.
Vesikari, T., Itzler, R., Matson, D. O., Santosham, M., Christie, C. D. C., Coia, M., … Heaton, P. (2007, December). Efficacy of a pentavalent rotavirus vaccine in reducing rotavirus-associated health care utilization across three regions (11 countries). International Journal of Infectious Diseases. https://doi.org/10.1016/S1201-9712(07)60019-8