Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-Dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines.

Trial Profile

Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-Dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines.

Withdrawn prior to enrolment
Phase of Trial: Phase I/II

Latest Information Update: 30 May 2014

At a glance

  • Drugs Bovine rotavirus vaccine reassortant (Primary)
  • Indications Rotavirus infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Shantha Biotechnics
  • Most Recent Events

    • 02 Feb 2010 Status changed from not yet recruiting to withdrawn prior to recruitment, as per ClinicalTrials.gov record.
    • 26 Jun 2009 Planned initiation date changed from 1 Mar 2009 to 1 Sep 2009 as reported by ClinicalTrials.gov.
    • 26 Jun 2009 Planned end date changed from 1 Apr 2010 to 1 Sep 2010 as reported by ClinicalTrials.gov.
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