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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Infections, Rotavirus

Treatments

Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00139347

444563/024

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

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.