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
Phase of Trial: Phase III
Latest Information Update: 23 Sep 2017
At a glance
- Drugs Bovine rotavirus vaccine reassortant (Primary)
- Indications Gastroenteritis; Rotavirus infections
- Focus Registrational; Therapeutic Use
- Sponsors Serum Institute of India
- 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.
- 13 Mar 2017 Status changed from active, no longer recruiting to completed.