Dataset from A Phase III, Observer-blind, Randomized, Multi-country Study to Assess the Reactogenicity and Safety of the Porcine Circovirus (PCV) Free Liquid Formulation of GSK's Oral Live Attenuated Human Rotavirus (HRV) Vaccine as Compared to the Lyophilized Formulation of the GSK's HRV Vaccine, When Administered as a 2-dose Vaccination in Infants Starting at Age 6-12 Weeks

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.