Trial Profile

A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 01 Dec 2018

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At a glance

Drugs Bovine rotavirus vaccine reassortant (Primary) ; Hib-DTaP-hepatitis B vaccine; Poliovirus vaccine; Rotavirus vaccine
Indications Rotavirus infections
Focus Pharmacodynamics; Registrational

09 Nov 2018 Results assessing safety and immunogenecity published in the Vaccine.
27 Sep 2018 According to a PATH media release, ROTASIIL achieved World Health Organization's (WHO's) prequalification Based on data from this and another study CTP700300192.
03 Oct 2017 Status changed from active, no longer recruiting to completed.

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