Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.

Inclusion criteria:

• Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

Exclusion criteria:

• Allergic reaction to vaccine components;
• clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
• immunocompromised.