Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants

PHASE2CompletedINTERVENTIONAL
Enrollment

534

Participants

Timeline

Start Date

November 5, 2019

Primary Completion Date

July 23, 2020

Study Completion Date

May 14, 2021

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

RSV MAT 60 µg

One single dose of RSV MAT 60 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

BIOLOGICAL

RSV MAT 120 µg

One single dose of RSV MAT 120 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

DRUG

Placebo

One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Trial Locations (32)

1010

GSK Investigational Site, Auckland

2013

GSK Investigational Site, Soweto

3168

GSK Investigational Site, Melbourne

4101

GSK Investigational Site, South Brisbane

6021

GSK Investigational Site, Wellington

13790

GSK Investigational Site, Johnson City

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Majadahonda (Madrid)

29004

GSK Investigational Site, Málaga

29600

GSK Investigational Site, Marbella

32401

GSK Investigational Site, Panama City

39503

GSK Investigational Site, Gulfport

42055

GSK Investigational Site, Saint-Etienne

45322

GSK Investigational Site, Englewood

63100

GSK Investigational Site, Clermont-Ferrand

63141

GSK Investigational Site, St Louis

70006

GSK Investigational Site, Metairie

75093

GSK Investigational Site, Plano

76104

GSK Investigational Site, Fort Worth

77702

GSK Investigational Site, Beaumont

83687

GSK Investigational Site, Nampa

85015

GSK Investigational Site, Phoenix

87102

GSK Investigational Site, Albuquerque

90057

GSK Investigational Site, Los Angeles

90255

GSK Investigational Site, Huntington Park

B3K 6R8

GSK Investigational Site, Halifax

G1V 4G2

GSK Investigational Site, Québec

00290

GSK Investigational Site, Helsinki

0801

GSK Investigational Site, Panama City

08035

GSK Investigational Site, Barcelona

09006

GSK Investigational Site, Burgos

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY