The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.
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Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination
Timeframe: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination
Timeframe: During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)
Number of Subjects With Any Unsolicited AEs
Timeframe: During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)
Number of Subjects With Any Serious Adverse Events (SAEs)
Timeframe: Throughout the study period (from Day 1 up to Month 7 or Month 8)