A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers

PHASE3TerminatedINTERVENTIONAL
Enrollment

384

Participants

Timeline

Start Date

August 3, 2021

Primary Completion Date

May 30, 2023

Study Completion Date

May 30, 2023

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

RSV MAT

Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.

DRUG

Placebo

Single dose of placebo, administered intramuscularly in the non-dominant arm, at Day 1.

Trial Locations (35)

2013

GSK Investigational Site, Soweto Gauteng

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Madrid

28660

GSK Investigational Site, Boadilla Del Monte Madrid

28850

GSK Investigational Site, TorrejOn Ardoz Madrid

29004

GSK Investigational Site, Málaga

35205

GSK Investigational Site, Birmingham

36305

GSK Investigational Site, Dothan

36608

GSK Investigational Site, Mobile

59100

GSK Investigational Site, Prato

59804

GSK Investigational Site, Missoula

70433

GSK Investigational Site, Covington

70458

GSK Investigational Site, Slidell

70508

GSK Investigational Site, Lafayette

75093

GSK Investigational Site, Plano

76012

GSK Investigational Site, Arlington

76051

GSK Investigational Site, Grapevine

76086

GSK Investigational Site, Weatherford

76104

GSK Investigational Site, Fort Worth

77008

GSK Investigational Site, Houston

77573

GSK Investigational Site, League City

78705

GSK Investigational Site, Austin

85015

GSK Investigational Site, Phoenix

98124

GSK Investigational Site, Messina

570015

GSK Investigational Site, Mysuru

751019

GSK Investigational Site, Bhubaneswar

95070-560

GSK Investigational Site, Caxias do Sul

14048-900

GSK Investigational Site, RibeirAo PretoSP

97105-900

GSK Investigational Site, Santa Maria

B3K 6R8

GSK Investigational Site, Halifax

H3T 1C5

GSK Investigational Site, Montreal

00290

GSK Investigational Site, Helsinki

06129

GSK Investigational Site, Perugia

0801

GSK Investigational Site, Panama City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04980391 - A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers | Biotech Hunter | Biotech Hunter