Key result
BRV-PV cuts severe rotavirus gastroenteritis by ~36% versus placebo in Indian infants.
Why the study?
Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries, causing significant morbidity, mortality, and economic burden, necessitating evaluation of a new vaccine.
Does the bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) prevent severe rotavirus gastroenteritis in Indian infants?
Comparison
Bovine-human reassortant pentavalent rotavirus vaccine vs placebo
Design
Randomized, double-blind, placebo-controlled Phase III clinical trial
Follow-up
Until children reached two years of age
Authors
Loading...
Supports BRV-PV use in Indian immunization programs; extends pentavalent rotavirus vaccine efficacy data to South Asian infants.
RCT (n=7,500)
Double-blind
1:1
Yes
Does the bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) prevent severe rotavirus gastroenteritis in Indian infants?
Effect estimate: Vaccine efficacy 36% (95% CI 11.7, 53.6)
p-value: p=0.0067
The BRV-PV vaccine is effective, well-tolerated, and safe in preventing severe rotavirus gastroenteritis in Indian infants.
Kulkarni et al. (2017) conducted an RCT in severe rotavirus gastroenteritis (n=7,500). bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) vs. Placebo was evaluated on severe rotavirus gastroenteritis (SRVGE) (Vaccine efficacy 36%, 95% CI 11.7, 53.6, p=0.0067). The bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) demonstrated 36% efficacy (95% CI 11.7-53.6; p=0.0067) against severe rotavirus gastroenteritis in Indian infants.
Synapse has enriched 3 closely related papers on similar clinical questions. Consider them for comparative context: