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Withdrawn prior to enrolment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
- 02 Feb 2010 Status changed from not yet recruiting to withdrawn prior to recruitment, as per ClinicalTrials.gov record.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.