Rotavirus Vaccines Clinical Trial
Official title:
Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
The primary objective of this study is to determine if the GSK Biologicals' human rotavirus
(HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on
immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the
20-point Vesikari scoring system [Ruuska, 1990]) caused by the circulating wild-type RV
strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until
Visit 5.
The primary objective will be reached if the lower limit of the 95% confidence interval (CI)
on vaccine efficacy is >0%.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
The study will have three groups: Rotarix 3-Dose Group, Rotarix 2-Dose Group and Placebo Group. Three-dose immunisation will be administered in healthy infants at approximately 6, 10, and 14 weeks of age. Routine EPI vaccinations will be administered concomitantly with the study vaccines. This study will also evaluate immunogenicity and safety relative to the placebo. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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