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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 04 May 2017

At a glance

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

    • 13 Mar 2017 Status changed from active, no longer recruiting to completed.
    • 05 Nov 2015 Planned End Date changed from 1 May 2017 to 1 Apr 2017, as reported by ClinicalTrials.gov record.
    • 05 Nov 2015 Planned primary completion date changed from 1 May 2016 to 1 Jan 2016, as reported by ClinicalTrials.gov record
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