A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

13,000

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
RSV InfectionsRSV ImmunisationPreterm Labour
Interventions
DRUG

Vaccine

The active ingredients in RSVpreF are 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B, in a lyophilized dosage form for reconstitution.

OTHER

Placebo

Placebo matched to vaccine but not containing any active ingredients

Trial Locations (5)

1864

Wits Vaccines & Infectious Diseases Analytics (VIDA) Research unit, Soweto

2001

Wits RHI Shandukani CRS, Hillbrow

2093

VIDA Nkanyezi Research Unit, Johannesburg

7700

MRC Unit on Child and Adolescent Health, Rondebosch

0152

Setshaba Research Centre, Soshanguve

All Listed Sponsors
collaborator

World Health Organization

OTHER

collaborator

Bill and Melinda Gates Foundation

OTHER

lead

University of Witwatersrand, South Africa

OTHER