Objective.—To determine the safety and relative efficacy of two reassortant rhesus rotavirus
vaccines over two rotavirus seasons. Design.—A prospective, double-masked, placebo-
controlled trial. Setting.—Twenty-three centers in the United States. Participants.—A total of
1006 healthy infants between 4 and 26 weeks of age were enrolled, and 898 received three
doses of vaccine or placebo. Main Outcome Measures.—Reactogenicity was determined by
comparing the incidence of fever, diarrhea, and/or vomiting for 5 days after each dose of …