A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

PHASE3CompletedINTERVENTIONAL
Enrollment

25,236

Participants

Timeline

Start Date

July 21, 2021

Primary Completion Date

July 21, 2023

Study Completion Date

July 21, 2023

Conditions
Respiratory Syncytial VirusesLower Respiratory Tract Disease
Interventions
BIOLOGICAL

Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF

Participants will receive a single IM injection of an RSV vaccine.

BIOLOGICAL

Placebo

Participants will receive a single IM injection of matching placebo.

Trial Locations (272)

110

Taipei Medical University, Taipei

116

Taipei Municipal Wanfang Hospital, Taipei

250

Madibeng Centre for Research, Brits

300

The Aurum Institute Rustenburg Clinical Research Site, Rustenburg

1010

Optimal Clinical Trials, Auckland

1401

CRISMO Bertha Gxowa Research Centre, Johannesburg

1501

Worthwhile Clinical trials, Johannesburg

1619

Clinresco Centres Pty Ltd, Johannesburg

1739

DJW Research, Krugersdorp

2059

Paratus Clinical Kanwal Clinic, Kanwal

2113

Newtown Clinical Research, Newtown

2230

Espoon rokotetutkimusklinikka, Espoo

2450

Northside Health, Coffs Harbour

2617

Paratus Clinical Canberra Clinic, Bruce

3010

Lakeland Clinical Trials, Rotorua

3110

P3 Research Ltd, Tauranga

3200

Lakeland Clinical Trials, Hamilton

3410

P3 Research Ltd, Havelock North

4101

Mater Hospital Brisbane, South Brisbane

4414

P3 Research Ltd, Palmerston North

5018

Lakeland Clinical Trials, Upper Hutt

5032

P3 Research Limited Kapiti, Paraparaumu

5241

Synergy Biomed Research Institute (SBRI), East London

6021

P3 Reaearch Wellington, Wellington

7011

Southern Clinical Trials Tasman, Main Road Stoke

7130

Synexus Helderberg Clinical Research Centre, Cape Town

7500

TREAD Research Tygerberg Hospital, Cape Town

7530

TASK Central, Cape Town

Tiervlei Trial Centre, Cape Town

7626

Be Part Yoluntu Centre, Western Cape

7646

Paarl Research Centre, Paarl

7700

Allergy Immunology Unit, Cape Town

8013

Southern Clinical Trials, Christchurch, Christchurch

9301

Iatros International, Bloemfontein

Josha Research, Bloemfontein

9460

Welkom Clinical Trial Centre, Welkom

10002

National Taiwan University Hospital, Taipei

10017

Synexus Clinical Research US Inc, Manhattan

10027

Harlem Hospital Center, New York

10117

OU Innomedica, Tallinn

10128

Center for Clinical and Basic Research, Tallinn

10312

Richmond Behavioral Associates, Staten Island

10330

King Chulalongkorn Memorial Hospital, Pathumwan

10400

Royal Thai Army, Afrims, Bangkok

The Vaccine Trial Center(VTC), Faculty of Tropical Medicine, Bangkok

10455

CHEAR Center, LLC, The Bronx

10700

Siriraj Hospital, Bangkok

11217

Taipei Veterans General Hospital, Taipei

11490

Tri-Service General Hospital, Taipei

13760

Meridian Clinical Research, LLC, Endwell

Regional Clinical Research, Inc., Endwell

14618

Finger Lakes Clinical Research, Rochester

15243

Preferred Primary Care Physicians Research, Pittsburgh

15401

Preferred Primary Care Physicians Research, Uniontown

20520

Turun rokotetutkimusklinikka, Turku

20850

Optimal Research, Rockville

21075

Centennial Medical Group, Elkridge

22601

Amherst Family Practice, PC, Winchester

22911

Charlottesville Medical Research Center, LLC, Charlottesville

23507

Clinical Research Associates of Tidewater, Norfolk

23606

Health Research of Hampton Roads, Inc, Newport News

24541

Spectrum Medical, Inc, Danville

27103

Accellacare Research of Cary, Winston-Salem

27401

Medication Management LLC, Greensboro

27518

Accellacare Research of Cary, Cary

27609

Accellacare Research of Cary, Raleigh

27612

Wake Research Associates, Raleigh

27704

M3-Emerging Medical Research, Durham

28100

Porin rokotetutkimusklinikka, Pori

28112

Monroe Biomedical Research, Monroe

28277

American Health Network, LLC, Charlotte

28401

PMG Research of Wilmington, LLC, Wilmington

Trial Management Associates, LLC, Wilmington

29303

Spartanburg Medical Research, Spartanburg

VitaLink Research Spartanburg, Spartanburg

29340

Velocity Clinical Research, Inc., Gaffney

29464

Coastal Carolina Research Center, Mt. Pleasant

PMG Research of Charleston, LLC, Mt. Pleasant

30281

Clinical Research Atlanta, Stockbridge

30328

Synexus Clinical Research US Inc, Atlanta

30331

Atlanta Center for Medical Research, Atlanta

31024

Accel Research Sites, Eatonton

31406

Meridian Clinical Research, LLC, Savannah

32127

Progressive Medical Research, Port Orange

32132

Velocity Clinical Research, Inc., Edgewater

32205

Westside Center for Clinical Research, Jacksonville

32216

Jacksonville Center For Clinical Research, Jacksonville

32720

Avail Clinical Research, LLC, DeLand

32801

Clinical NeuroScience Solutions Inc, Orlando

32806

Headlands Research Orlando, Orlando

Synexus Clinical Research US Inc, Orlando

32934

Optimal Research, Melbourne

33009

Velocity Clinical Research, Hallandale Beach, Hallandale

33100

Tampereen rokotetutkimusklinikka, Tampere

33134

Clinical Research of South Florida, an AMR Company, Coral Gables

Prestige Clinical Research Center, Inc., Coral Gables

33135

Suncoast Research Group, Miami

33161

Healthcare Clinical Data Inc., North Miami

33162

Harmony Clinical Research Inc, North Miami Beach

33165

New Horizon Research Center, Miami

33173

Suncoast Research Associates, LLC, Miami

33186

Clinical Site Partners, LLC, Miami

33305

Chang Gung Memorial Hospital- Linkou, Taoyuan

33321

DBC Research, Tamarac

33409

Palm Beach Research Center, West Palm Beach

33461

Altus Research, Inc, Lake Worth

33462

JEM Research LLC, Atlantis

33709

Sandhill Research, St. Petersburg

33781

Synexus Clinical Research US Inc, Pinellas Park

33803

Accel Research Sites, Lakeland

33912

AMR Fort Myers Clinical Physiology Associates, an AMR company, Fort Myers

34748

Compass Research LLC, Leesburg

35205

Central Research Associates, Inc., Birmingham

35211

Synexus Clinical Research US Inc, Birmingham

35216

Achieve Clinical Research, LLC, Birmingham

35802

Optimal Research, Huntsville

36608

Coastal Clinical Research, Inc, Mobile

37203

Clinical Research Associates Inc, Nashville

37620

PMG Research of Bristol, Bristol

37920

VGR & NOCCR - Knoxville, Knoxville

39531

MedPharmics - Biloxi, Biloxi

40002

Srinagarind Hospital, Khon Kaen

40202

University of Louisville, Louisville

40447

China Medical University Hospital, Taichung

40509

Central Kentucky Research Associates, Inc., Lexington

43212

Synexus Clinical Research US Inc, Columbus

44122

Rapid Medical Research, Cleveland

44311

Synexus Clinical Research US Inc, Akron

45236

Synexus Clinical Research US Inc, Cincinnati

45242

Velocity Clinical Research, Cincinnati

46383

Buynak Clinical Research, Valparaiso

47714

Medisphere Medical Research Center, Llc, Evansville

50106

Clinical Research Centre, Tartu

50200

Maharaj Nakorn Chiang Mai hospital Faculty of Medicine, Muang

50266

The Iowa Clinic, P.C., West Des Moines

55423

Synexus Clinical Research US Inc, Richfield

57049

Meridian Clinical Research - Dakota Dunes, Dakota Dunes

59701

Mercury Street Medical Group, PLLC, Butte

60100

Seinäjoen rokotetutkimusklinikka, Seinäjoki

60602

Synexus Clinical Research US Inc, Chicago

61614

Optimal Research, Peoria

61822

Christie Clinic, Champaign

63141

Sundance Clinical Research, St Louis

Synexus Clinical Research US Inc, St Louis

64114

The Center for Pharmaceutical Research (CPR), Kansas City

65109

Jefferson City Medical Group Family, Jefferson City

66219

Johnson County Clin-Trials, Lenexa

67010

Heartland Research Associates, LLC, Augusta

67100

Kokkolan rokotetutkimusklinikka, Kokkola

67114

Heartland Research Associates, LLC, Newton

67207

Heartland Clinical Research, Wichita

68134

Meridian Clinical Research - Omaha, Omaha

68144

Synexus Clinical Research US Inc, Omaha

68701

Meridian Clinical Research, LLC, Norfolk

70065

Medpharmics, LLC, Kenner

70112

Tulane University School of Medicine, New Orleans

70119

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company, New Orleans

70508

Medpharmics, LLC, Lafayette

70601

Centex Studies, Inc., Lake Charles

71201

Clinical Trials of America, Monroe

72205

Baptist Health Center For Clinical Research, Little Rock

73072

Lynn Institute of Norman, Norman

73099

Tekton Research Inc., Yukon

73112

Lynn Health Science Institute, Oklahoma City

75093

Research Your Health, Plano

75231

Synexus Clinical Research US Inc, Dallas

75246

North Texas Infectious Diseases Consultants, Dallas

77017

Vilo Research Group Inc, Houston

77081

Texas Center for Drug Development Inc, Houston

77375

DM Clinical Research, Tomball

Martine Diagnostic Clinic, Tomball

78229

Clinical Trials of Texas Inc, San Antonio

Synexus Clinical Research US Inc, San Antonio

78240

Tekton Research Inc., San Antonio

78613

Advanced Clinical Research, Cedar Park

78705

Central Texas Clinical Research, Austin

Optimal Research, Austin

78745

Tekton Research Inc., Austin

Tekton Research Inc., Beaumont

80014

Synexus Clinical Research US Inc, Aurora

80033

Paradigm Clinical Research Centers, Inc., Wheat Ridge

80501

Tekton Research Inc., Longmont

80528

Tekton Research Inc., Fort Collins

80756

Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City

83642

Advanced Clinical Research, Boise

84041

Synexus Clinical Research US Inc, Layton

84088

Advanced Clinical Research, West Jordan

84123

Synexus Clinical Research US Inc, Murray

85020

Central Phoenix Medical Clinic, Phoenix

85224

Synexus Clinical Research US Inc, Chandler

85283

Clinical Research Consortium Arizona, Tempe

85379

Medpharmics, LLC, Phoenix

85381

Hope Research Institute, Peoria

85741

Synexus Clinical Research US Inc, Tucson

87102

Medpharmics, LLC, Albuquerque

89052

Synexus Clinical Research US Inc, Henderson

89119

Clinical Research Consortium, an AMR company, Las Vegas

90220

Oulun rokotetutkimusklinikka, Oulu

90703

Synexus Clinical Research US Inc, Cerritos

91303

Hope clinical Research LLC, Canoga Park

91942

Velocity Clinical Research, San Diego, La Mesa

91978

Encompass Clinical Research, Spring Valley

92083

Synexus Clinical Research US Inc, Vista

92108

Optimal Research, San Diego

92220

Rancho Paseo Medical Group, Banning

96001

Paradigm Clinical Research Centers, Inc., Redding

97504

Clinical Research Institute of Southern Oregon, P.C., Medford

97527

Clinical Research Institute of Southern Oregon, P.C., Grants Pass

222200

Donghai County Center for Disease prevention and Control, Lianyungang

224435

Funing County Center for Disease Control and Prevention, Yancheng

224554

Binhai County Center for Disease Control and Prevention, Yancheng

623832

Synexus Polska Sp z o o Oddzial w Warszawie, Warsaw

919111

eStudySite, Chula Vista

2260734

CENRESIN, Quilota

3465586

Centro de Investigacion del Maule, Talca

8331143

Centro de Estudios Clínicos e Investigación Médica (CeCim), Santiago

46617-2808

The South Bend Clinic Center for Research, South Bend

04240

Central Maine Medical Center, Lewiston

02886

Omega Medical Research, Warwick

29621-2062

Synexus Clinical Research US Inc, Anderson

69304-000

UFRR - Universidade Federal de Roraima, Boa Vista

36010 570

CMIP - Centro Mineiro de Pesquisa Ltda, Juiz de Fora

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

15090 000

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base, São José do Rio Preto

01228-900

CPQuali Pesquisa Clinica LTDA ME, São Paulo

V1Y 1Z9

Okanagan Clinical Trials, Kelowna

L7R 1E2

LMC Clinical Research dba Manna Research Inc. Burlington, Burlington

M4G 3E8

LMC Clinical Research Inc. (Bayview), Toronto

M9W 4L6

LMC Clinical Research dba Manna Research Inc. Toronto, Toronto

G6W 0M5

LMC Clinical Research dba Manna Research Inc. Quebec City, Lévis

H9R 4S3

LMC Clinical Research dba Manna Research Inc. Montreal, Pointe-Claire

G1N 4V3

DIEX Recherche Quebec Inc., Québec

J6E 2B4

DIEX Recherche Joliette Inc., Saint-Charles-Borromée

J1L 0H8

DIEX Recherche Sherbrooke Inc, Sherbrooke

G6P 6P6

DIEX Recherche Victoriaville Inc., Victoriaville

00100

Etelä-Helsingin rokotetutkimusklinikka, Helsinki

00930

Itä-Helsingin rokotetutkimusklinikka, Helsinki

04400

Järvenpään rokotetutkimusklinikka, Järvenpää

0600

Southern Clinical Trials Totara Clinical Research, Auckland

0626

Southern Clinical Trials, Waitemata, Auckland

42-202

Synexus Polska Sp. z o.o. Oddzial w Czestochowie, Częstochowa

80-382

Synexus Polska Sp. z o.o. Oddzial w Gdansku, Gdansk

81 537

Synexus Scm Sp Z o o Oddzial Gdynia, Gdynia

40 040

Synexus Polska Sp z o o Oddzial w Katowicach, Katowice

90 127

Synexus Polska Sp z o o, Lodz

20 362

KO MED Centra Kliniczne LUBLIN, Lublin

60-702

Synexus Polska Sp. z.o.o. Oddzial w Poznaniu, Poznan

24-100

KO MED Centra Kliniczne Pulawy, Puławy

60 185

Centrum Medyczne Pratia Poznan, Skorzewo

28 200

KO-MED Centra Kliniczne Staszow, Staszów

50 381

Synexus Polska Sp z o o Oddzial we Wroclawiu, Wroclaw

22 400

KO MED Centra Kliniczne Zamosc, Zamość

06530

TASK Central, George

0122

Stanza Clinical Research Centre : Mamelodi, Mamelodi East

0001

Global Clin Trials Pretoria, Pretoria

Unknown

Synexus Watermeyer, Pretoria

Synexus Scotland Clinical Research Centre, Glasgow

01475

REIMED Vosloorus, Vosloorus

B15 2SQ

Synexus Midlands Clinical Research Centre, Birmingham

B21 9RY

FutureMeds Soho Health Centre, Birmingham

BD9 6RJ

Bradford Royal Infirmary, Bradford

CH62 6EE

FutureMeds Bridle Clinic, Bromborough

CF15 9SS

Synexus Wales Clinical Research Center, Cardiff

PR7 7NA

Synexus Lancashire Clinical Research Centre, Chorley

G51 4TF

Panthera Biopartners, Glasgow

NE46 1QJ

Synexus Hexham General Hospital, Hexham

L22 0LG

Synexus Merseyside Clinical Research Centre, Liverpool

M15 6SX

Synexus Manchester Clinical Research Center, Manchester

M8 5RB

North Manchester General Hospital, Manchester

PR2 9RB

Panthera Biopartners, Preston

RG2 9LH

Panthera Biopartners, Reading

TS19 8PE

University Hospital of North Tees, Stockton-on-Tees

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT04908683 - A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older | Biotech Hunter | Biotech Hunter