Dataset from Immunogenicity and Safety Study of Two Different Formulations of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, Rotarix in Healthy Infants

The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK
Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when
administered as a two-dose primary vaccination in healthy infants aged 6-10 weeks at dose
one, with no previous history of rotavirus illness or vaccination.

While the lyophilized formulation of the HRV vaccine was licensed in India in February 2008,
this study is conducted to generate additional clinical data for the liquid formulation of
the HRV vaccine in India, as recommended by New Drug Advisory Committee on Vaccines
(NDAC-Vaccines) of Drug Controller General of India (DCGI).