Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial.

•A randomized, double-blind, placebo-controlled trial was conducted in healthy Chinese infants.•Efficacy and safety of a pentavalent rotavirus vaccine (RV5) were assessed.•Efficacy against rotavirus gastroenteritis of any-severity caused by any serotype was 69.3%.•Efficacy against severe rotavirus gastroenteritis caused by any serotype was 78.9%.•RV5 was efficacious and generally well-tolerated in Chinese infants.