A Phase I/II Study of the All In One Liquid Formulation of a Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) to Sequentially Evaluate the Safety and Tolerability of a Single Dose in Healthy Adult Volunteers Followed by Evaluation of the Safety, Tolerability and Immunogenicity (Dose Response) of a Three Administration Series in Healthy Infants in India.

Trial Profile

A Phase I/II Study of the All In One Liquid Formulation of a Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) to Sequentially Evaluate the Safety and Tolerability of a Single Dose in Healthy Adult Volunteers Followed by Evaluation of the Safety, Tolerability and Immunogenicity (Dose Response) of a Three Administration Series in Healthy Infants in India.

Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Aug 2016

At a glance

  • Drugs Bovine rotavirus vaccine reassortant (Primary) ; Rotavirus W179-9 vaccine
  • Indications Rotavirus infections
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 31 Jul 2013 Status changed from recruiting to completed as reported by Clinical Trials Registry - India record.
    • 09 Aug 2012 New trial record
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