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