A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants.

•Pentavalent reassortant rotavirus vaccine (BRV-PV) was tested for lot-to-lot consistency in Indian infants.•The vaccine demonstrated safety profile similar to licensed Rotarix®.•Lot-to-lot consistency in the immunogenicity of BRV-PV was demonstrated in terms of GMC ratios of IgA antibodies.•The immune responses between the pooled BRV-PV arms and Rotarix® were comparable.