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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jun 2024

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At a glance

  • Drugs Bovine rotavirus vaccine reassortant (Primary)
  • Indications Gastroenteritis; Rotavirus infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Serum Institute of India

Most Recent Events

  • 05 Jun 2024 Results assessing the relative proportion of enteric pathogens associated with severe gastroenteritis (GE) among children younger than 2 years published in the American Journal of Tropical Medicine and Hygiene
  • 23 Sep 2017 Primary endpoint (Occurrence of Severe Rotavirus Gastroenteritis) has been met, according to results published in the Vaccine Journal.
  • 23 Sep 2017 Complete analysis results published in the Vaccine Journal.

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