NCT04010448View on ClinicalTrials.gov

A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India

PHASE3RecruitingINTERVENTIONAL
Enrollment

8,200

Participants

Timeline

Start Date

October 10, 2019

Primary Completion Date

December 15, 2025

Study Completion Date

December 15, 2025

Conditions
Rotavirus Infection of Children
Interventions
BIOLOGICAL

TV P2-VP8

90 µg of the TV P2-VP8 vaccine IM plus oral placebo administered on study days 1, 29 and 57

BIOLOGICAL

Rotarix

Rotarix® PO plus IM placebo administered on study days 1, 29 and 57

Trial Locations (1)

Unknown

RECRUITING

Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

SK Bioscience Co., Ltd.

INDUSTRY

lead

PATH

OTHER