Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants

NCT02133690 Phase 3 COMPLETED

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

Details

Lead sponsor	Serum Institute of India Pvt. Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	7500
Start date	2014-05
Completion	2017-03

Conditions

• Rotavirus Gastroenteritis

Interventions

• Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)
• Placebo

Primary outcomes

• occurrence of Severe Rotavirus Gastroenteritis — Up to 2 years of age of participants
  Laboratory confirmed cases of severe rotavirus gastroenteritis occurring in infants receiving the complete vaccination regimen occurring from 14 days after the third vaccine dose until 122 cases are accrued, or until all participating infants reach two years of age (per protocol analysis).

Countries

India