Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger

PHASE3CompletedINTERVENTIONAL
Enrollment

6,586

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2020

Conditions
Severe Rotavirus Gastroenteritis
Interventions
BIOLOGICAL

Rotavirus vaccine (BRV-PV)

Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9, or placebo, will be administered at 4 week intervals between doses (with a window of -1 to +4 weeks). The first administration will occur at 6-8 weeks of age.

BIOLOGICAL

Placebo

Trial Locations (1)

Unknown

Madarounfa Health District, Madarounfa

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Medecins Sans Frontieres, Netherlands

OTHER

collaborator

Serum Institute of India Pvt. Ltd.

INDUSTRY

collaborator

FORSANI (Forum Santé Niger)

UNKNOWN

collaborator

Ministère de la Santé Publique, Niger

UNKNOWN

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

lead

Epicentre

OTHER

NCT02145000 - Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger | Biotech Hunter | Biotech Hunter