Phase I Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Tolerability of a Single Administration (10e6.25 FFU of Each Constituent Serotype Per 0.5 ml) of Live Attenuated Tetravalent (G1-G4) Bovine-human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Adult Males.

Trial Profile

Phase I Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Tolerability of a Single Administration (10e6.25 FFU of Each Constituent Serotype Per 0.5 ml) of Live Attenuated Tetravalent (G1-G4) Bovine-human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Adult Males.

Completed
Phase of Trial: Phase I

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Bovine rotavirus vaccine reassortant (Primary)
  • Indications Rotavirus infections
  • Focus Adverse reactions
  • Most Recent Events

    • 01 Apr 2014 Results published in the Vaccine.
    • 07 Jun 2011 Actual end date (May 2010) added as reported by ClinicalTrials.gov.
    • 29 Jun 2010 Status changed from not yet recruiting to completed as reported by Clinical Trials Registry - India record.
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