OTHER CTRI/2015/12/006428.

Trial name or title	"Randomized open label study to compare immunogenicity and safety of ROTAVAC® and ROTARIX® rotavirus vaccine"
Methods	Randomized, parallel‐group, active controlled trial
Participants	Number: 464 Description: Healthy infants, age 6 ‐ 8 weeks
Interventions	1. 3 doses ROTAVAC®: 0.5 mL single dose containing NLT 105.0 FFU of live rotavirus116E 2. 2 doses RV1: Each 1‐mL dose contains a suspension of at least 106.0 median Cell Culture Infective Dose (CCID50) Schedule: 4‐week interval between doses
Outcomes	1. Immunogenicity (GMTs) 2. Safety solicited for 7 days 3. SAEs throughout the study period
Starting date	December 2015 Completion: not stated
Contact information	Dr Binod Sah, binod3161@bharatbiotech.com
Notes	Location: India Registration number: CTRI/2015/12/006428 Source of funding: Bharat Biotech