Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

PHASE3CompletedINTERVENTIONAL
Enrollment

26,675

Participants

Timeline

Start Date

May 25, 2021

Primary Completion Date

April 11, 2022

Study Completion Date

May 31, 2024

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

Placebo

Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 and before Season 2 to the Placebo Group, and before Season 2 to the participants of the RSVPreF3 Group, that are re-randomized to the RSV\_1 dose group.

BIOLOGICAL

RSVPreF3 OA vaccine

RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at Day 1 in the RSVPreF3 group, and before Season 2 to the participants of the RSVPreF3 group that are re-randomized to the RSV\_annual group.

Trial Locations (277)

1010

GSK Investigational Site, Grafton Auckland

1022

GSK Investigational Site, Moloto South

1055

GSK Investigational Site, Middelburg

1459

GSK Investigational Site, Reiger Park

1632

GSK Investigational Site, Tembisa

1818

GSK Investigational Site, Johannesburg

2010

GSK Investigational Site, Darlinghurst

2113

GSK Investigational Site, Johannesburg

2217

GSK Investigational Site, Botany

2450

GSK Investigational Site, Coffs Harbour

2650

GSK Investigational Site, Edegem

2800

GSK Investigational Site, Mechelen

3001

GSK Investigational Site, Tauranga

3120

GSK Investigational Site, Tremelo

3124

GSK Investigational Site, Camberwell

3220

GSK Investigational Site, Geelong

3500

GSK Investigational Site, Linkebeek

3545

GSK Investigational Site, Linkebeek

3570

GSK Investigational Site, Alken

3600

GSK Investigational Site, Genk

4068

GSK Investigational Site, Taringa

4121

GSK Investigational Site, Tarragindi

4130

GSK Investigational Site, Havelock North

4506

GSK Investigational Site, Morayfield

4987

GSK Investigational Site, Linkebeek

5032

GSK Investigational Site, Kapiti

GSK Investigational Site, Palmerston North

5101

GSK Investigational Site, Erpent

6021

GSK Investigational Site, Wellington

6163

GSK Investigational Site, Spearwood

6534

GSK Investigational Site, Linkebeek

6887

GSK Investigational Site, Linkebeek

7700

GSK Investigational Site, Cape Town

8025

GSK Investigational Site, Barcelona

8900

GSK Investigational Site, Ieper

9000

GSK Investigational Site, Ghent

9300

GSK Investigational Site, Aalst

9301

GSK Investigational Site, Newcastle

9690

GSK Investigational Site, Linkebeek

10017

GSK Investigational Site, Jamaica

10023

GSK Investigational Site, Chieri Torino

10117

GSK Investigational Site, Tallinn

GSK Investigational Site, Berlin

10128

GSK Investigational Site, Tallinn

10617

GSK Investigational Site, Tallinn

12627

GSK Investigational Site, Berlin

13100

GSK Investigational Site, Vercelli

13347

GSK Investigational Site, Berlin

13619

GSK Investigational Site, Tallinn

14584

GSK Investigational Site, Bucheon-si Kyunggi-do 14584

14609

GSK Investigational Site, Rochester

15100

GSK Investigational Site, Alessandria

15236

GSK Investigational Site, Pittsburgh

15355

GSK Investigational Site, Ansan

15706

GSK Investigational Site, Santiago de Compostela

16132

GSK Investigational Site, Genova

16508

GSK Investigational Site, Erie

20095

GSK Investigational Site, Hamburg

20157

GSK Investigational Site, Milan

20162

GSK Investigational Site, Milan

20520

GSK Investigational Site, Turku

20854

GSK Investigational Site, Rockville

22143

GSK Investigational Site, Hamburg

22869

GSK Investigational Site, Schenefeld

23502

GSK Investigational Site, Norfolk

26426

GSK Investigational Site, Kangwon-do

27103

GSK Investigational Site, Winston-Salem

27804

GSK Investigational Site, Rocky Mount

28006

GSK Investigational Site, Madrid

28007

GSK Investigational Site, Madrid

28029

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28100

GSK Investigational Site, Pori

28117

GSK Investigational Site, Statesville

28144

GSK Investigational Site, Salisbury

28222

GSK Investigational Site, Madrid

28601

GSK Investigational Site, Hickory

28922

GSK Investigational Site, Alcorcón

29405

GSK Investigational Site, Mt. Pleasant

29621

GSK Investigational Site, Anderson

30159

GSK Investigational Site, Hanover

30328

GSK Investigational Site, Atlanta

31203

GSK Investigational Site, Chihuahua City

31406

GSK Investigational Site, Binghamton

32055

GSK Investigational Site, Lake City

32100

GSK Investigational Site, Belluno

32162

GSK Investigational Site, The Villages

32205

GSK Investigational Site, Jacksonville

32806

GSK Investigational Site, Orlando

32934

GSK Investigational Site, Melbourne

33100

GSK Investigational Site, Tampere

33134

GSK Investigational Site, Coral Gables

33174

GSK Investigational Site, Miami

33409

GSK Investigational Site, West Palm Beach

33781

GSK Investigational Site, Pinellas Park

33912

GSK Investigational Site, Fort Myers

34607

GSK Investigational Site, Weeki Wachee

35205

GSK Investigational Site, Birmingham

35211

GSK Investigational Site, Birmingham

35802

GSK Investigational Site, Huntsville

37024

GSK Investigational Site, Negrar Verona

37530

GSK Investigational Site, León

37912

GSK Investigational Site, Knoxville

38119

GSK Investigational Site, Memphis

40509

GSK Investigational Site, Lexington

41944

GSK Investigational Site, Daegu

42202

GSK Investigational Site, Częstochowa

43212

GSK Investigational Site, Columbus

44124

GSK Investigational Site, Ferrara

44311

GSK Investigational Site, Akron

45236

GSK Investigational Site, Cincinnati

45355

GSK Investigational Site, Essen

45359

GSK Investigational Site, Essen

45459

GSK Investigational Site, Centerville

46015

GSK Investigational Site, Valencia

46544

GSK Investigational Site, Mishawaka

47574

GSK Investigational Site, Goch

47714

GSK Investigational Site, Evansville

51014

GSK Investigational Site, Tartu

51069

GSK Investigational Site, Cologne

53100

GSK Investigational Site, Siena

54907

GSK Investigational Site, Jeonju

55116

GSK Investigational Site, Mainz

55423

GSK Investigational Site, Richfield

56126

GSK Investigational Site, Pisa

58455

GSK Investigational Site, Witten

60100

GSK Investigational Site, Seinäjoki

60313

GSK Investigational Site, Frankfurt

60602

GSK Investigational Site, Chicago

63141

GSK Investigational Site, St Louis

64114

GSK Investigational Site, Kansas City

64570

GSK Investigational Site, Monterrey

65439

GSK Investigational Site, Flörsheim

67042

GSK Investigational Site, El Dorado

67100

GSK Investigational Site, Kokkola

67114

GSK Investigational Site, Newton

67205

GSK Investigational Site, Wichita

67207

GSK Investigational Site, Wichita

68000

GSK Investigational Site, Oaxaca City

68134

GSK Investigational Site, Omaha

69469

GSK Investigational Site, Weinheim

70121

GSK Investigational Site, Bari

72713

GSK Investigational Site, Paide

75234

GSK Investigational Site, Dallas

76070

GSK Investigational Site, Querétaro

76104

GSK Investigational Site, Fort Worth

76248

GSK Investigational Site, Keller

77008

GSK Investigational Site, Houston

77055

GSK Investigational Site, Houston

78209

GSK Investigational Site, San Luis Potosí City

78229

GSK Investigational Site, San Antonio

80131

GSK Investigational Site, Napoli

80339

GSK Investigational Site, München

84041

GSK Investigational Site, Layton

84106

GSK Investigational Site, Murray

85221

GSK Investigational Site, Dachau

85306

GSK Investigational Site, Phoenix

85741

GSK Investigational Site, Tucson

88100

GSK Investigational Site, Catanzaro

88239

GSK Investigational Site, Wangen

89052

GSK Investigational Site, Henderson

90127

GSK Investigational Site, Palermo

90220

GSK Investigational Site, Oulu

90703

GSK Investigational Site, Cerritos

92653

GSK Investigational Site, Laguna Hills

94574

GSK Investigational Site, Wallerfing

97070

GSK Investigational Site, Würzburg

GSK Investigational Site, Mérida

115478

GSK Investigational Site, Moscow

188300

GSK Investigational Site, Gatchina

191119

GSK Investigational Site, StPetersburg

196143

GSK Investigational Site, StPetersburg

196158

GSK Investigational Site, Saint Petersburg

197022

GSK Investigational Site, Saint Petersburg

620137

GSK Investigational Site, Yekaterinburg

650066

GSK Investigational Site, Kemerovo

656043

GSK Investigational Site, Barnaul

T5A 4L8

GSK Investigational Site, Edmonton

V3L 3W4

GSK Investigational Site, New Westminster

V3S 2N6

GSK Investigational Site, Surrey

V6Z 2T1

GSK Investigational Site, Vancouver

V8V 3M9

GSK Investigational Site, Victoria

V8V 4A1

GSK Investigational Site, Victoria

B3J 3G9

GSK Investigational Site, Halifax

B2N 1L2

GSK Investigational Site, Truro

P3C 1X3

GSK Investigational Site, Greater Sudbury

N5W 6A2

GSK Investigational Site, London-Ontario

K1H 8L6

GSK Investigational Site, Ottawa

N7T 4X3

GSK Investigational Site, Sarnia

M9W 4L6

GSK Investigational Site, Toronto

G7H 7Y8

GSK Investigational Site, Chicoutimi

J7J 2K8

GSK Investigational Site, Mirabel

H9R 4S3

GSK Investigational Site, Pointe-Claire

G1W 4R4

GSK Investigational Site, Québec

J6E 2B4

GSK Investigational Site, Saint-Charles-Borromée

G1E 7G9

GSK Investigational Site, Sainte-Foy

J1J 2G2

GSK Investigational Site, Sherbrooke

02230

GSK Investigational Site, Espoo

00100

GSK Investigational Site, Helsinki

00930

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

09599

GSK Investigational Site, Freiberg

01762

GSK Investigational Site, Dippoldiswalde

01279

GSK Investigational Site, Dresden

01705

GSK Investigational Site, Freital

04103

GSK Investigational Site, Leipzig

04347

GSK Investigational Site, Leipzig

00128

GSK Investigational Site, Roma

00168

GSK Investigational Site, Roma

292-0805

GSK Investigational Site, Chiba

732-0053

GSK Investigational Site, Hiroshima

306-0041

GSK Investigational Site, Ibaraki

860-0863

GSK Investigational Site, Kumamoto

901-2393

GSK Investigational Site, Okinawa

530-0001

GSK Investigational Site, Osaka

350-1122

GSK Investigational Site, Saitama

421-0193

GSK Investigational Site, Shizuoka

121-0815

GSK Investigational Site, Tokyo

160-0017

GSK Investigational Site, Tokyo

165-0031

GSK Investigational Site, Tokyo

169-0072

GSK Investigational Site, Tokyo

990-0834

GSK Investigational Site, Yamagata

750-0061

GSK Investigational Site, Yamaguchi

01120

GSK Investigational Site, Mexico City

06760

GSK Investigational Site, Mexico City

03100

GSK Investigational Site, RM Pharmamexico CITY

82-300

GSK Investigational Site, Elblag

80-382

GSK Investigational Site, Gdansk

81-537

GSK Investigational Site, Gdynia

40-040

GSK Investigational Site, Katowice

40-282

GSK Investigational Site, Katowice

40-648

GSK Investigational Site, Katowice

31-501

GSK Investigational Site, Krakow

90-127

GSK Investigational Site, Lodz

91-363

GSK Investigational Site, Lodz

05-500

GSK Investigational Site, Piaseczno

60-702

GSK Investigational Site, Poznan

02-672

GSK Investigational Site, Warsaw

03-291

GSK Investigational Site, Warsaw

96-500

GSK Investigational Site, Warsaw

50-381

GSK Investigational Site, Wroclaw

53-673

GSK Investigational Site, Wroclaw

400-711

GSK Investigational Site, Incheon

06351

GSK Investigational Site, Seoul

07441

GSK Investigational Site, Seoul

08308

GSK Investigational Site, Seoul

135-720

GSK Investigational Site, Seoul

137-701

GSK Investigational Site, Seoul

442-723

GSK Investigational Site, Suwon Gyeonggi-do

08023

GSK Investigational Site, Barcelona

08025

GSK Investigational Site, Barcelona

08036

GSK Investigational Site, Barcelona

08430

GSK Investigational Site, Barcelona

08500

GSK Investigational Site, Barcelona

08540

GSK Investigational Site, Barcelona

08907

GSK Investigational Site, Barcelona

CH63 9JP

GSK Investigational Site, Bebington

BT7 2EB

GSK Investigational Site, Belfast

B15 2SQ

GSK Investigational Site, Birmingham

BA15 1DQ

GSK Investigational Site, Bradford on Avon Wiltsh

CF15 9SS

GSK Investigational Site, Cardiff

NN17 2UR

GSK Investigational Site, Corby

OX29 4QB

GSK Investigational Site, Eynsham

ML4 3NJ

GSK Investigational Site, Glasgow

NE461QJ

GSK Investigational Site, Hardwick

NE46 1QJ

GSK Investigational Site, Hexham

PR7 7NA

GSK Investigational Site, Lancashire

L22 0LG

GSK Investigational Site, Liverpool

M15 6SX

GSK Investigational Site, Manchester

BR5 3QG

GSK Investigational Site, Orpington

GSK Investigational Site, Romford

OX4 1XB

GSK Investigational Site, Oxford

PE8 6PL

GSK Investigational Site, Peterborough

CV32 4RA

GSK Investigational Site, Royal Leamington Spa

IP24 2HY

GSK Investigational Site, Thetford Norfolk

OX28 6JS

GSK Investigational Site, Witney

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY