PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 15:39:14 GMT) CTRI Number CTRI/2009/091/001080 [Registered on: 28/06/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study A clinical Trial to study the safety, immunogenicity and tolerability of a tetravalent rotavirus vaccine in Indian infants. Scientific Title of Phase I/II, randomized, double-blind, placebo-controlled, dosage selection (10e5.5 or 10e6.25 FFU Study 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. Secondary IDs if Any Secondary ID Identifier NCT01061658 ClinicalTrials.gov SBL/BRV-TV/Form1/PhI/2009/0100 Protocol Number SBL/BRV-TV/Form1/PhI/2009/0100 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr. Gagandeep Kang Trial Coordinator (multi-center study) Designation Affiliation Address Department of Gastrointestinal Sciences, Christian Medical College Vellore TAMIL NADU 632004 India Phone 0416-2282052 Fax 0416-2282486 Email
[email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr. Raman Rao Query) Designation Affiliation Shantha Biotechnics Limited Address VP, R&D, 4th Floor, Vasantha Chambers, Fateh Maidan Road, Basheer Bagh Hyderabad ANDHRA PRADESH 500004 India Phone 040-66301800 Fax 040-23234133 Email
[email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr.