Neonatal Immunization with a Novel Vaccine Against Rotavirus

Rotavirus continues to be a major cause of gastroenteritis globally, but vaccine efficacy is suboptimal because of cost, availability, and concerns about the safety of neonatal immunization. The novel RV3-BB vaccine contains rotavirus strain RV3, which was isolated from the stools of asymptomatic infants. Infection with this naturally attenuated strain has been reported to prevent severe gastroenteritis for up to 3 years. To assess the efficacy and safety of neonatal or infant vaccination with RV3-BB, investigators enrolled 1513 Indonesian infants, all of whom received four doses of vaccine or placebo (at 0–5 days, 8–10 weeks, 14–16 weeks, and 18–20 weeks); use of placebo was judged acceptable because rotavirus vaccination is not in the Ind…