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. 2019 Oct 28;2019(10):CD008521. doi: 10.1002/14651858.CD008521.pub5

RV5 NCT02728869.

Trial name or title "Safety, Reactogenicity and Immunogenicity of Heat‐stable Rotavirus Vaccine (HSRV) in Adults and Infants"
Methods Phase I/II, randomized, single‐blind trial
Participants Number: 100
Description: Healthy infants of either sex, 6 ‐ 8 weeks of age; healthy adults
Interventions 1. Hilleman Labs heat stable pentavalent vaccine
2. RV5
Schedule: 3 doses at 4‐week intervals
Outcomes 3. Any adverse event
4. Serious adverse events
5. Anti‐Rotavirus IgA sero‐response rate
7. Viral shedding
Starting date June 2016
Completion: April 2017
Contact information K Zaman, MBBS, PhD; International Center for Diarrheal Disease Research, Bangladesh
Notes Location: Bangladesh
Registration number: NCT02728869
Source of funding: MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.

BRV: bovine‐human reassortant vaccine; GMT: geometric mean titre; SAE: serious adverse event