OTHER NCT01061658.

Trial name or title	"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"
Methods	"Randomized, Placebo Control, Safety Study, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator)"
Participants	Number: 90 (target) Description: healthy infants of either sex, 6 to 8 weeks of age at time of enrolment
Interventions	1. Live attenuated tetravalent (G1 ‐ G4) bovine‐human reassortant rotavirus vaccine 2. Placebo
Outcomes	1. Reactogenicity 2. Adverse events 3. Shedding of vaccine rotavirus in stool samples 4. Seroconversion rate 5. Sero‐response rate 6. GMT of serum IgA antibody against rotavirus
Starting date	1 July 2010 Completion: not stated
Contact information	Gagandeep Kang, MD PhD, gkang@cmcvellore.ac.in
Notes	Location: India Registration number: NCT01061658 Source of funding: Shantha Biotechnics Limited