RotaTeq: Phase III data

In the Asian portion of a double-blind Phase III trial in 2,036 infants ages 4-12 weeks, RotaTeq was 48.3% effective in preventing severe rotavirus gastroenteritis at nearly 2 years of follow up. Specifically, 38 cases of severe rotavirus gastroenteritis were reported during >1,197 person-years of follow up for the vaccine group vs. 71 cases in >1,156 person-years for placebo.

In the African portion of the trial in 5,468 infants ages 4-12 weeks, RotaTeq was 39.3% effective in preventing severe rotavirus gastroenteritis at nearly 2 years of follow up. Specifically, 79 cases of disease were reported during >2,611 person-years of follow up for the vaccine group vs. 129 cases in >2,586 person-years for placebo. Infants received oral RotaTeq or placebo at around 6, 10 and 14 weeks of age in addition to routine vaccinations. Data were published in The Lancet. ...