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Clinical Trial Summary

This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.


Clinical Trial Description

The hypothesis is that a three dose series of BRV-PV administered orally to healthy Indian infants, with the initial dose given at 6-8 weeks of age and followed by vaccinations at monthly intervals, will significantly reduce the incidence of severe rotavirus gastroenteritis (SRVGE). Duration of follow-up is until aged 2 years of each enrolled child. The study is powered to detect vaccine efficacy significantly greater than 10% (95% confidence interval lower bound > 10%) if the true vaccine efficacy is 50% or higher. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02133690
Study type Interventional
Source Serum Institute of India Pvt. Ltd.
Contact
Status Completed
Phase Phase 3
Start date May 2014
Completion date March 2017

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