Objectives Between 2001–2004, 70,301 healthy infants 6 to 12 week-old were enrolled in 11 countries in the Rotavirus Efficacy and Safety Trial (REST) to receive three oral doses of the pentavalent rotavirus vaccine, RotaTeq, containing the five most common human rotavirus serotypes G1, G2, G3, G4, and P1A, or placebo. Active surveillance for hospitalizations and emergency department (ED) visits for acute gastroenteritis (AGE) was conducted 7, 14, and 42 days after each dose and then every 6 weeks for up to two years. Here we report the rate reduction for rotavirus-associated hospitalizations and ED visits in all infants receiving ⩾1 dose.

Methods Rotavirus AGE (RVGE) was defined as forceful vomiting and/or ⩾3 watery or looser-than-normal stools within a 24-hour period and detection of rotavirus by ELISA and PCR assay. Analyses were performed using Poisson regression in all subjects who received ⩾1 dose.

Results The mean length of follow-up after the first dose was 314.5 days in recipients of RotaTeq and 314.4 days in placebo recipients. The rate reduction for hospitalizations and ED visits for G1-4 RVGE occurring after the first dose was 91.9% [95% CI: 88.0 to 94.5] in recipients of RotaTeq. Results for individual serotypes are summarized in the table.

Conclusion RotaTeq consistently decreased the rates of hospitalizations and ED visits for rotavirus AGE caused by each of the five most common human rotavirus serotypes observed in REST.