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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

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
  • Most Recent Events

    • 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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