A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers

PHASE3TerminatedINTERVENTIONAL
Enrollment

11,194

Participants

Timeline

Start Date

November 20, 2020

Primary Completion Date

June 14, 2023

Study Completion Date

June 14, 2023

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

RSV MAT

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

DRUG

Placebo

One dose of placebo (lyophilized sucrose reconstituted with NaCl solution) administered intramuscularly in the non-dominant arm at Day 1.

Trial Locations (159)

333

GSK Investigational Site, Taoyuan District

500

GSK Investigational Site, Changhua

833

GSK Investigational Site, Kaohsiung City

1000

GSK Investigational Site, Manila

1001

GSK Investigational Site, Panama City

1008

GSK Investigational Site, Manila

1010

GSK Investigational Site, Grafton Auckland

1425

GSK Investigational Site, Buenos Aires

1701

GSK Investigational Site, Papatoetoe Auckland

2112

GSK Investigational Site, Johannesburg

2117

GSK Investigational Site, Soweto

3000

GSK Investigational Site, Leuven

3080

GSK Investigational Site, Seoul

3100

GSK Investigational Site, Sylhet

3168

GSK Investigational Site, Clayton

3220

GSK Investigational Site, Geelong

3600

GSK Investigational Site, Genk

4101

GSK Investigational Site, South Brisbane

4114

GSK Investigational Site, Cavite

4215

GSK Investigational Site, Southport

5800

GSK Investigational Site, Córdoba

6009

GSK Investigational Site, Nedlands

6021

GSK Investigational Site, Wellington

7096

GSK Investigational Site, Panama City

8500

GSK Investigational Site, Kortrijk

9000

GSK Investigational Site, Ghent

9100

GSK Investigational Site, Sint-Niklaas

10041

GSK Investigational Site, Taipei

10330

GSK Investigational Site, Bangkok

10449

GSK Investigational Site, Taipei

13760

GSK Investigational Site, Houston

20122

GSK Investigational Site, Milan

20142

GSK Investigational Site, Milan

20154

GSK Investigational Site, Milan

20162

GSK Investigational Site, Milan

20520

GSK Investigational Site, Turku

21101

GSK Investigational Site, San Pedro Sula

28007

GSK Investigational Site, Madrid

28023

GSK Investigational Site, Aravaca

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28100

GSK Investigational Site, Novara

28222

GSK Investigational Site, Madrid

28400

GSK Investigational Site, Madrid

28660

GSK Investigational Site, Boadilla Del Monte Madrid

28850

GSK Investigational Site, TorrejOn Ardoz Madrid

28905

GSK Investigational Site, Getafe

29004

GSK Investigational Site, Málaga

29010

GSK Investigational Site, Málaga

29603

GSK Investigational Site, Marbella

29607

GSK Investigational Site, Greenville

29708

GSK Investigational Site, Hendersonville

31000

GSK Investigational Site, Chihuahua City

32401

GSK Investigational Site, Panama City

33000

GSK Investigational Site, Bordeaux

33100

GSK Investigational Site, Tampere

33174

GSK Investigational Site, Miami

34295

GSK Investigational Site, Montpellier

35205

GSK Investigational Site, Birmingham

36305

GSK Investigational Site, Dothan

36608

GSK Investigational Site, Mobile

37126

GSK Investigational Site, Verona

40447

GSK Investigational Site, Taichung

41013

GSK Investigational Site, Seville

41014

GSK Investigational Site, Seville

42601

GSK Investigational Site, Daegu

45322

GSK Investigational Site, Englewood

46017

GSK Investigational Site, Valencia

46702

GSK Investigational Site, Valencia

47012

GSK Investigational Site, Valladolid

48013

GSK Investigational Site, Bilbao

48201

GSK Investigational Site, Detroit

48604

GSK Investigational Site, Saginaw

50042

GSK Investigational Site, Medellín

50200

GSK Investigational Site, Chiang Mai

58260

GSK Investigational Site, Morelia

59100

GSK Investigational Site, Prato

59804

GSK Investigational Site, Missoula

63100

GSK Investigational Site, Clermont-Ferrand

64460

GSK Investigational Site, Monterrey

64570

GSK Investigational Site, Monterrey

67100

GSK Investigational Site, Kokkola

68000

GSK Investigational Site, Oaxaca City

68516

GSK Investigational Site, Lincoln

68701

GSK Investigational Site, Norfolk

68803

GSK Investigational Site, Grand Island

69495

GSK Investigational Site, Pierre-Bénite

70124

GSK Investigational Site, Bari

70433

GSK Investigational Site, Covington

70458

GSK Investigational Site, Slidell

70508

GSK Investigational Site, Lafayette

75050

GSK Investigational Site, Arlington

75093

GSK Investigational Site, Plano

75149

GSK Investigational Site, Mesquite

75231

GSK Investigational Site, Dallas

75679

GSK Investigational Site, Paris

76028

GSK Investigational Site, Burleson

76086

GSK Investigational Site, Weatherford

76104

GSK Investigational Site, Fort Worth

76248

GSK Investigational Site, Keller

76550

GSK Investigational Site, Lampasas

76800

GSK Investigational Site, San Juan del Río

77008

GSK Investigational Site, Houston

77058

GSK Investigational Site, Houston

77573

GSK Investigational Site, League City

78200

GSK Investigational Site, San Luis Potosí City

78503

GSK Investigational Site, McAllen

78626

GSK Investigational Site, Georgetown

78705

GSK Investigational Site, Austin

83221

GSK Investigational Site, Blackfoot

83404

GSK Investigational Site, Idaho Falls

83686

GSK Investigational Site, Nampa

83687

GSK Investigational Site, Nampa

85006

GSK Investigational Site, Phoenix

85712

GSK Investigational Site, Tucson

87102

GSK Investigational Site, Albuquerque

90057

GSK Investigational Site, Los Angeles

90127

GSK Investigational Site, Palermo

90220

GSK Investigational Site, Oulu

91506

GSK Investigational Site, Burbank

98124

GSK Investigational Site, Messina

110111

GSK Investigational Site, Bogotá

GSK Investigational Site, Medellín

250001

GSK Investigational Site, Chía

411043

GSK Investigational Site, Pune

412216

GSK Investigational Site, Vadu Budruk Pune

441108

GSK Investigational Site, Nagpur

570015

GSK Investigational Site, Mysore

575001

GSK Investigational Site, Mangalore

700017

GSK Investigational Site, Kolkata

760002

GSK Investigational Site, Barranquilla

760042

GSK Investigational Site, Cali Colombia

90035001

GSK Investigational Site, Porto Alegre

C1141ACG

GSK Investigational Site, Ciudad AutOnoma de Buenos Aire

C1425EFD

GSK Investigational Site, Ciudad AutOnoma de Buenos Aire

T4000IHE

GSK Investigational Site, San Miguel de Tucumán

Unknown

GSK Investigational Site, Matlab

GSK Investigational Site, Santo Domingo Este

GSK Investigational Site, Comayagua

95070-560

GSK Investigational Site, Caxias do Sul

26030-380

GSK Investigational Site, Nova Iguaçu

14048-900

GSK Investigational Site, RibeirAo PretoSP

97105-900

GSK Investigational Site, Santa Maria

15090-000

GSK Investigational Site, São José do Rio Preto

B3K 6R8

GSK Investigational Site, Halifax

K7L 2V7

GSK Investigational Site, Kingston

H3T 1C5

GSK Investigational Site, Montreal

G1V 4G2

GSK Investigational Site, Québec

00290

GSK Investigational Site, Helsinki

0801

GSK Investigational Site, Panama City

0184

GSK Investigational Site, Pretoria

0152

GSK Investigational Site, Soshanguve

08308

GSK Investigational Site, Seoul

08028

GSK Investigational Site, Barcelona

08035

GSK Investigational Site, Barcelona

08950

GSK Investigational Site, Barcelona

09006

GSK Investigational Site, Burgos

0105

GSK Investigational Site, Taipei

EH16 4SA

GSK Investigational Site, Edinburgh

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04605159 - A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers | Biotech Hunter | Biotech Hunter