A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control

PHASE3CompletedINTERVENTIONAL
Enrollment

3,962

Participants

Timeline

Start Date

February 7, 2023

Primary Completion Date

January 15, 2025

Study Completion Date

January 15, 2025

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

RSVPreF3 vaccine

No intervention is administered in this extension study. Participants received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of RSVPreF3 vaccine except in RSV MAT-011 study, where some participants received a second dose as well.

OTHER

Control

No intervention is administered in this extension study. Participants received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of any control (placebo, Tdap or influenza vaccine).

Trial Locations (138)

333

GSK Investigational Site, Taoyuan District

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

2013

GSK Investigational Site, Soweto Gauteng

2112

GSK Investigational Site, Johannesburg

3000

GSK Investigational Site, Leuven

3100

GSK Investigational Site, Sylhet

3168

GSK Investigational Site, Clayton

4101

GSK Investigational Site, South Brisbane

4215

GSK Investigational Site, Southport

5800

GSK Investigational Site, Córdoba

6002

GSK Investigational Site, Wellington

7099

GSK Investigational Site, Panama City

9000

GSK Investigational Site, Ghent

9100

GSK Investigational Site, Sint-Niklaas

10041

GSK Investigational Site, Taipei

10330

GSK Investigational Site, Bangkok

15706

GSK Investigational Site, Santiago de Compostela

20154

GSK Investigational Site, Milan

20520

GSK Investigational Site, Turku

21101

GSK Investigational Site, San Pedro Sula

22143

GSK Investigational Site, Hamburg

28006

GSK Investigational Site, Madrid

28007

GSK Investigational Site, Madrid

28023

GSK Investigational Site, Aravaca

28034

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28100

GSK Investigational Site, Pori

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

29603

GSK Investigational Site, Marbella

29607

GSK Investigational Site, Greenville

29708

GSK Investigational Site, Hendersonville

30159

GSK Investigational Site, Hanover

33000

GSK Investigational Site, Bordeaux

33100

GSK Investigational Site, Tampere

36608

GSK Investigational Site, Mobile

39531

GSK Investigational Site, Biloxi

40447

GSK Investigational Site, Taichung

41013

GSK Investigational Site, Seville

41014

GSK Investigational Site, Seville

45322

GSK Investigational Site, Englewood

46017

GSK Investigational Site, Valencia

46020

GSK Investigational Site, Valencia

46702

GSK Investigational Site, Valencia

47012

GSK Investigational Site, Valladolid

47574

GSK Investigational Site, Goch

48013

GSK Investigational Site, Bilbao

48201

GSK Investigational Site, Detroit

48604

GSK Investigational Site, Saginaw

50200

GSK Investigational Site, Chiang Mai

55116

GSK Investigational Site, Mainz

59100

GSK Investigational Site, Prato

60100

GSK Investigational Site, Seinäjoki

67100

GSK Investigational Site, Kokkola

68701

GSK Investigational Site, Norfolk

69500

GSK Investigational Site, Bron

70124

GSK Investigational Site, Bari

70433

GSK Investigational Site, Covington

70458

GSK Investigational Site, Slidell

75093

GSK Investigational Site, Plano

75679

GSK Investigational Site, Paris

76012

GSK Investigational Site, Keller

76028

GSK Investigational Site, Keller

76051

GSK Investigational Site, Keller

76086

GSK Investigational Site, Weatherford

76104

GSK Investigational Site, Fort Worth

76550

GSK Investigational Site, Lampasas

77008

GSK Investigational Site, Houston

78705

GSK Investigational Site, Austin

83686

GSK Investigational Site, Nampa

83702

GSK Investigational Site, Nampa

85015

GSK Investigational Site, Phoenix

85712

GSK Investigational Site, Tucson

87107

GSK Investigational Site, Albuquerque

90057

GSK Investigational Site, Los Angeles

90220

GSK Investigational Site, Oulu

91506

GSK Investigational Site, Burbank

97070

GSK Investigational Site, Würzburg

98104

GSK Investigational Site, Seattle

98124

GSK Investigational Site, Messina

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

Unknown

GSK Investigational Site, Matlab

GSK Investigational Site, Santo Domingo Este

GSK Investigational Site, Comayagua

GSK Investigational Site, Seoul

26030-380

GSK Investigational Site, Nova Iguaçu

14051-140

GSK Investigational Site, RibeirAo PretoSP

97105-900

GSK Investigational Site, Santa Maria

15090-000

GSK Investigational Site, São José do Rio Preto

V3S 2N6

GSK Investigational Site, Surrey

V6Z 2T1

GSK Investigational Site, Vancouver

B3K 6R8

GSK Investigational Site, Halifax

B2N 1L2

GSK Investigational Site, Truro

K7L 2V7

GSK Investigational Site, Kingston

N5W 6A2

GSK Investigational Site, London-Ontario

N7T 4X3

GSK Investigational Site, Sarnia

M9W 4L6

GSK Investigational Site, Toronto

J6E 6A9

GSK Investigational Site, Joliette

H3T 1C5

GSK Investigational Site, Montreal

H9R 4S3

GSK Investigational Site, Montreal

J7J 2K8

GSK Investigational Site, Montreal

G1V 4G2

GSK Investigational Site, Québec

G1W 4R4

GSK Investigational Site, Québec

J1L 0H8

GSK Investigational Site, Sherbrooke

050034

GSK Investigational Site, Medellín

02230

GSK Investigational Site, Espoo

00100

GSK Investigational Site, Helsinki

00290

GSK Investigational Site, Helsinki

00930

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

07079

GSK Investigational Site, Panama City

0801

GSK Investigational Site, Panama City

0184

GSK Investigational Site, Pretoria

0152

GSK Investigational Site, Soshanguve

425-707

GSK Investigational Site, Ansan

08308

GSK Investigational Site, Seoul

08035

GSK Investigational Site, Barcelona

09006

GSK Investigational Site, Burgos

0105

GSK Investigational Site, Taipei

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT05705440 - A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control | Biotech Hunter | Biotech Hunter