Phase I/II, Randomized, Double-blind, Placebo-controlled, Dosage Selection (10e5.5 or 10e6.25 FFU of Each Constituent Serotype Per 0.5 mL) 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.

Trial Profile

Phase I/II, Randomized, Double-blind, Placebo-controlled, Dosage Selection (10e5.5 or 10e6.25 FFU of Each Constituent Serotype Per 0.5 mL) 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.

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 27 Feb 2017

At a glance

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

    • 01 Oct 2010 Planned end date changed from 1 Aug 2010 to 1 Dec 2010 as reported by ClinicalTrials.gov.
    • 23 Jul 2010 Actual initiation date (14 Jul 2010) added as reported by Clinical Trials Registry - India.
    • 23 Jul 2010 Status changed from not yet recruiting to recruiting as reported by Clinical Trials Registry - India.
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