Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

850

Participants

Timeline

Start Date

February 22, 2021

Primary Completion Date

September 6, 2022

Study Completion Date

September 9, 2022

Conditions
Rotavirus Vaccine
Interventions
BIOLOGICAL

RV3-BB

1.0 mL of the thawed rotavirus vaccine to be administered orally at birth, 6 weeks and 10 weeks of age

BIOLOGICAL

Trivalent P2-VP8

0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at approximately 6, 10 and 14 weeks of age

BIOLOGICAL

Rotarix

1.5 mL of the liquid vaccine containing the RIX4414 strain of human rotavirus vaccine to be administered orally at 6 weeks and 10 weeks of age.

BIOLOGICAL

RV3-BB birth dose

1.0 mL of the thawed rotavirus vaccine to be administered orally at birth.

BIOLOGICAL

Trivalent P2-VP8 Booster dose

0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at 14 weeks of age

Trial Locations (2)

2003

Wits RHI Shandukani Research Centre, Johannesburg

2013

Vaccine and Infectious Diseases Analytics (VIDA) - formerly known as Respiratory and Meningococcal Pathogens Research Unit (RMPRU), Johannesburg

Sponsors
All Listed Sponsors
collaborator

SK Bioscience Co., Ltd.

INDUSTRY

collaborator

Murdoch Childrens Research Institute

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Bill and Melinda Gates Foundation

OTHER

lead

PATH

OTHER