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Clinical Trial Summary

The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).


Clinical Trial Description

"The study will have four groups: Group HRV + OPV, Group HRV alone, Group Placebo + OPV and Group Placebo alone. Two-dose immunisation will be administered in healthy infants at approximately 12 and 16 weeks of age. Immunogenicity, reactogenicity and safety relative to the placebo will also be evaluated. Treatment allocation: randomized (2:2:1:1). Routine EPI vaccines should be administered during the study following the EPI recommendation in Bangladesh." ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00139334
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date June 2005
Completion date January 2006

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