A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

PHASE3CompletedINTERVENTIONAL
Enrollment

17,935

Participants

Timeline

Start Date

June 30, 2021

Primary Completion Date

August 27, 2025

Study Completion Date

August 27, 2025

Conditions
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
Interventions
BIOLOGICAL

ExPEC9V

ExPEC9V will be administered as an IM injection.

OTHER

Placebo

Matching placebo will be administered as an IM injection.

Trial Locations (373)

333

Chang Gung Memorial Hospital Linkou Branch, Taoyuan District

632

Optimal Clinical Trials, Rosedale

704

National Cheng Kung University Hospital, Tainan City

813

Kaohsiung Veterans General Hospital, Kaohsiung City

1011

Optimal Clinical Trials, Auckland

2025

Middlemore Clinical Trials, Papatoetoe

2145

Westmead Hospital, Sydney

2305

John Hunter Hospital, New Lambton

2650

Hvidovre Hospital, Hvidovre

2730

Gentofte Hospital, Herlev

2900

Aalborg Universitetshospital Nord, Hellerup

3010

Lakeland Clinical Trials, Rotorua

Hosp. Gral. Univ. Dr. Balmis, Alicante

3110

P3 Research Ltd, Tauranga

3112

Tauranga Urology Research Limited, Bay of Plenty

3118

Culloden Research Ltd, Papamoa

3200

Lakeland Clinical Trials, Hamilton

3220

Barwon Health - University Hospital Geelong, Geelong

3400

Nordsjaellands Hospital - Hillerod, Hilleroed

4000

Sjællands University hospital, Roskilde

4001

Saint Andrew's War Memorial Hospital, Brisbane

4068

AusTrials Pty Ltd, Taringa

4101

Mater Medical Centre South Brisbane, South Brisbane

4103

SIBAmed GmbH & Co. KG, Leipzig

4121

AusTrials Pty Ltd, Tarragindi

4122

P3 Research Ltd, Hastings

4414

P3 Research Ltd, Palmerston North

5000

CMAX Clinical Research, Melbourne

5010

P3 Research - Lower Hutt, Lower Hutt

5011

Adelaide Medical Solutions, Woodville

5018

Lakeland Clinical Trials, Upper Hutt

5032

P3 Research Limited Kapiti, Wellington

5074

GP Surgery - Campbelltown, Campbelltown

5096

McIntyre Medical Center, Para Hills West

5097

Bene Aged Care - Italian Village, St Agnes

5108

North West Medical Center, Salisbury

5230

Odense Universitetshospital, Odense M

6242

Capatial & Coast District Health Board, Wellington

6961

Fiona Stanley Hospital, Palmyra DC

7011

Southern Clinical Trials Ltd, Nelson

8003

Hosp. Del Mar, Barcelona

8013

Canterbury Urology Research Trust, Christchurch

Southern Clinical Trials Ltd, Christchurch Central

8028

Consorci D'Atenció Primària de Salut Barcelona Esquerra, Barcelona

8308

Korea University Guro Hospital, Seoul

8430

CAP Dr. Vicenç Papaceit ABS LA ROCA, La Roca del Vallès

9016

P3 Research Ltd, Dunedin

10016

Manhattan Medical Research, New York

10330

King Chulalongkorn Memorial Hospital, Bangkok

Thai Red Cross Aids Research Centre, Bangkok

10400

Ramathibodi Hospital, Bangkok

Tropical Medicine Hospital, Mahidol University, Bangkok

10467

Montefiore Medical Center, The Bronx

10700

Siriraj Hospital, Bangkok

11407

Hosp. de Jerez de La Frontera, Jerez de la Frontera

13000

Gona s.R.o- Orfinace Harov, Prague

13620

Seoul National University Bundang Hospital, Seongnam-si

13760

Meridian Clinical Research, LLC, Endwell

13901

Meridian Clinical Research, LLC, Binghamton

14004

Hosp Reina Sofia, Córdoba

15355

Korea University Ansan Hospital, Gyeonggi-do

16247

The Catholic university of Korea, St. Vincent's Hospital, Suwon

17007

Hosp. Univ. Dr. Josep Trueta, Girona

17011

Capital Area Research, Camp Hill

18057

Universitaetsmedizin Rostock, Rostock

19611

Reading Hospital, West Reading

20852

Kaiser Permanente, Rockville

21000

CHU Dijon Bourgogne - Hopital Francois Mitterrand, Dijon

21428

Skanes universitetssjukhus, Malmo

22322

Inha University Hospital, Incheon

22601

Selma Medical Associates, Winchester

22911

Charlottesville Medical Research Center, LLC, Charlottesville

23435

IACT - Suffolk Multispecialty Research, Suffolk

23758

Red-Institut für medizinische Forschung und Fortbildung, Oldenburg in Holstein

23858

Praxis Dr. Weimer, Reinfeld

24253

Hallym University Chuncehon Medical Center, Chuncheon

24501

Infectious Disease Associates of Central Virginia, Lynchburg

25187

Helsingborgs lasarett, Helsingborg

26505

Exemplar Research, Inc, Morgantown

27705

Durham VAMC, Durham

27834

ECU Health Vidant Medical Center, Greenville

28006

Hosp. Univ. de La Princesa, Madrid

28046

Hosp. Univ. La Paz, Madrid

28050

Hospital Sanitas La Moraleja, Madrid

28303

Carolina Institute for Clinical Research, Fayetteville

28660

Hosp. Univ. Hm Monteprincipe, Madrid

29004

Hosp. Quirónsalud Málaga, Málaga

29412

Hugh D. Durrence, MD, PC, Charleston

29566

Waterway Familiy Medicine, Little River

30029

CHU Nimes Hopital Caremeau, Nîmes

30033

Atlanta VA Medical Center, Decatur

30100

Ambulance name: Gynekologická ordinace MUDr, Pilsen

30328

Agile Clinical Research Trials, LLC, Atlanta

31904

Columbus Regional Research Institute, Columbus

32005

Complexo Hosp. Univ. de Ourense, Ourense

32055

Multi Specialty Research Associates Inc, Lake City

32607

Florida Medical Research Institute, Gainesville

32720

Accel Research Sites, DeLand

32751

ClinCloud Clinical Research, Maitland

32801

Clinical NeuroScience Solutions Inc, Orlando

32808

Omega Research Consultants, Orlando

33012

Indago Research & Health Center Inc, Hialeah

33024

Pines Care Research Center Inc, Pembroke Pines

33030

Prestige Clinical Research, Homestead

33124

Nova Clinical Research Center, Miami

33126

Finlay Medical Research, Miami

33133

Royal Care Medical Research Corporation, Miami

33134

Advanced Clinical Research Network, Coral Gables

Prestige Clinical Research Center, Inc., Coral Gables

33135

Retreat Medical Research LLC, Miami

Suncoast Research Group, Miami

33144

Dynamic Medical Research, LLC, Miami

33155

Florida International Medical Research, Miami

Health- Life Research Inst, Miami

Office of Dr. Marisela Gonzalez, Miami

33166

Doral Medical Research, Doral

Universal Axon Clinical Research, Doral

33180

Ideal Clinical Research, Adventura

33185

Felicidad Medical Research, Miami

33186

A and R Research Group, Miami

Alpha Science Research, Miami

33511

Clinical Research of Brandon, Brandon

Moore Clinical Reseach - Brandon Clinic, Brandon

33563

Clinical Research of Central Florida, Plant City

33603

Tampa General Hospital, Tampa

33613

Theia Clincial Research, LLC, Tampa

33614

Precision Research Institute, Tampa

St. Joseph's Comprehensive Research Institute, Tampa

33615

Santos Research Center, Tampa

33625

Care Access Research, Tampa

33744

Bay Pines VA Healthcare System, Bay Pines

33755

Florida Medical Center of Clearwater, Clearwater

33756

Innovative Research of West Florida, Incorporated, Clearwater

34209

Nova Clinical Research, LLC, Bradenton

34609

Care Access Research, Spring Hill

35015

Chungnam National University Hospital, Daejeon

35037

Universitaetsklinikum Giessen und Marburg GmbH, Marburg

35976

Lakeview Clinical Research, Guntersville

36312

Hosp. Alvaro Cunqueiro, Vigo

37001

Ordinace Hradebni s.r.o., České Budějovice

37179

BTH Research & Development Clinic, Karlskrona

39465

MediSync Clinical Research, Petal

39811

Zdravi-fit, s.r.o., Protivín

41009

Hosp. Virgen Macarena, Seville

42270

CHU Saint Etienne Hopital Nord, Saint-Priest-en-Jarez

43153

CTC GoCo, Mölndal

43215

Remington Davis Inc, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

44281

Meir Medical Center, Kfar Saba

44691

Comprehensive Internal Medicine, Wooster

45322

Kroger Health, Englewood

45458

Kroger Health, Centerville

46324

Asha Clinical Research-Munster Llc, Hammond

46544

Mishawaka Osteopathic Clinic/MOC Research, Mishawaka

47714

Medisphere Medical Research Center, Llc, Evansville

48073

William Beaumont Hospital, Royal Oak

48202

Henry Ford Hospital, Detroit

50002

Centrum Ockovani a Cestovi Mediciny, Hradec Králové

52621

The Chaim Sheba Medical Center, Ramat Gan

54449

Marshfield Clinic, Marshfield

56601

Progerint s.r.o., Vysoké Mýto

58104

Plains Clinical Research, Fargo

60590

Universitatsklinikum Frankfurt, Frankfurt

60611

Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion, Chicago

60612

Jesse Brown VAMC Department of Surgery, Chicago

University Of Illinois, Chicago

61500

Uromeda, Brno

66100

ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti, Chieti

67226

Cypress Medical Research Center, Wichita

68516

Be Well Clinical Studies, Lincoln

68701

Meridian Clinical Research, LLC, Norfolk

68803

Meridian Clinical Research, LLC, Grand Island

69004

Hopital de La Croix Rousse, Lyon

69495

Centre hospitalier Lyon-Sud, Pierre-Bénite

70072

Tandem Clinical Research, Marrero

70121

Ochsner Medical Center, New Orleans

70362

Universitetssjukhuset Orebro, Örebro

71457

KAMP Medical Research, Inc, Natchitoches

72205

Baptist Health Center For Clinical Research, Little Rock

72400

GYNURO s.r.o, Ostrava-Proskovice

73099

Tekton Research Inc., Yukon

74370

Centre Hospitalier Annecy Genevois, Annecy

75057

EPIC Clinical Research, Lewisville

75092

Sherman Clinical Research, Sherman

75149

SMS Clinical Research LLC, Mesquite

75224

Global Medical Research - Dallas, Dallas

75230

Medical City Dallas, Dallas

75246

North Texas Infectious Diseases Consultants, Dallas

77024

Digestive Health Associates, Houston

77401

Novel Research LLC, Bellaire

77900

PreventaMed, s.r.o., Olomouc

78229

Audie L Murphy Memorial Va Ho, San Antonio

78681

Be Well Clinical Studies, Round Rock

80020

IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S., Barranquilla

83404

Clinical Research Prime, Idaho Falls

Snake River Research, PLLC, Idaho Falls

84020

Lone Peak Family Medicine, Draper

85018

Hope Research Institute, Phoenix

85108

Hope Research Institute, Phoenix

85357

Interspond-Clinical Research Institute of AZ, Sun City West

87042

CHU de Limoges, Limousis

89106

Hope Research Institute, Las Vegas

Sierra Clinical Research, Las Vegas

89109

Excel Clinical Research, Las Vegas

89509

VA Sierra Nevada Health Care System, Reno

90017

American Institute of Research, Los Angeles

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

Southern California Permanente Medical Group, Los Angeles

90048

Comprehensive Urology, Los Angeles

90073

Veterans Affairs Greater Los Angeles HCS, Los Angeles

90621

Sun Urology - Buena Park Office, Buena Park

90806

Long Beach Clinical Trials, LLC, Long Beach

91303

Hope clinical Research LLC, Canoga Park

91767

Empire Clinical Research, LLC, Pomona

Inland Urology Medical Group, Pomona

91773

California Kidney Specialists, San Dimas

91786

San Antonio Regional Hospital, Upland

91911

Velocity Clinical Research, Inc., Chula Vista

91942

California Adult Circumcision - Alvarado La Mesa Urology Center, La Mesa

92120

San Diego Sports Medicine & Family Health Center, San Diego

92123

Medical Associates Research Group, Inc., San Diego

92647

Marvel Clinical Research, Huntington Beach

UC Davis Health System, Sacramento

92663

Hoag Medical Group, Newport Beach

92705

Prestige Medical Group, Santa Ana

93065

Millennium Clinical Trials LLC, Simi Valley

93534

Om Research LLC, Lancaster

94612

Kaiser Permanente Vaccine Study Center, Oakland

95655

VA Sacramento Medical Center, Mather

95821

Northern California Research, Sacramento

97227

Kaiser Permanente, Portland

99004

Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney, Cheney

170001

Asociacion IPS Medicos Internistas de Caldas, Manizales

200040

Huashan Hospital affiliated to Fudan University, Shanghai

210009

Jiangsu Provincial Center for Disease Control and Prevention, Nanjing

211112

Nanjing Medical University, Nanjing

214200

Yixing People's Hospital, Wuxi

215002

Suzhou Municipal Hospital, Suzhou

225300

Taizhou Peoples Hospital, Taizhou

226022

Regency health super specialty hospital, Lucknow

230601

Anhui Provincial Center for Disease Control and Prevention, Hefei

236399

Funan Center for Disease Control and Prevention, Fuyang

237400

Huoqiu County Center For Disease Control and Prevention, Liuan

252432

Centro de Atencion e Investigacion Medica S.A. - CAIMED, Girardot

302006

S. R. Kalla Memorial General Hospital, Jaipur

310003

1st Affiliated Hospital of Zhejiang University Medical College, Hangzhou

360004

Shree Giriraj Multispeciality Hospital, Rajkot

395002

Nirmal Hospital Pvt. Ltd., Surat

395009

BAPS Pramukhswami Hospital, Surat

421203

Asian Institute Of Medical Science, Mumbai

500001

Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc, Villavicencio

507001

CAIMED Acacias, Meta

510120

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

510260

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

570015

Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research, Mysuru

590010

KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC), Belagavi

610041

West China School of Medicine/West China Hospital, Sichuan University, Chengdu

660003

Fundacion Centro de Investigaciones Clinicas IPS Cardiomet, Pereira

700014

Nil Ratan Sircar Medical College and Hospital, Kolkata

856010

Centro de Atencion e Investigacion Medica S.A. - CAIMED, Casanare

1100776

Indraprastha Apollo Hospital, New Delhi

1408522

Tokyo Shinagawa Hospital, Shinagawa City

3928510

Japanese Red Cross Society Suwa Hospital, Suwa-Shi

5016062

Matsunami General Hospital, Hashima-gun

5340024

Kyobashi Sugimoto Clinic, Osaka

5530003

Japan Community Health Care Organization Osaka Hospital, Osaka

5650814

Suita Tokushukai Hospital, Suita-Shi

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

7500061

Shimonoseki City Hospital, Shimonoseki-shi

7692393

National Hospital Organization Shikoku Cancer Center, Sanuki

7747629

Samson Assuta Ashdod University Hospital, Ashdod

8000295

Japan Community Health care Organization Kyushu Hospital, Kitakyushu

8191104

Inoue Hospital, Itoshima

8700039

Abe Diabetes Clinic, Ōita

8701195

Almeida Memorial Hospital, Ōita

9010493

Nanbu Tokushukai Hospital, Shimajiri-Gun

9112001

Hadassah Medical Center, Jerusalem

90806-2766

Atlantic Urology Medical Group, Long Beach

06510

Yale University, New Haven

33144-4273

Continental Research, Miami

02111

Floating Hospital For Children at Tufts Medical Center, Boston

02132-4927

West Roxbury Veterans Affairs Medical Center, West Roxbury

08844

I.D. Care, Inc., Hillsborough

07666

Holy Name Medical Center, Teaneck

22003-7347

Clinical Alliance for Research and Education, Annandale

T4P 1K4

CARe Clinical Ltd, Calgary

CARe Clinical Ltd, Red Deer

T6G121

University of Alberta, Edmonton

V6Z2C7

Vancouver ID Research and Care Centre Society, Vancouver

P3E 5J1

Health Sciences North, Greater Sudbury

N1H 1B1

Dawson Road Family Health Team, Guelph

N7T 4X3

Bluewater Clinical Research Group Inc., Sarnia

K0C2K0

Winchester District Memorial Hospital, Winchester

G2J 0C4

Alpha Recherche Clinique, Québec

G3K 2P8

Alpha Recherche Clinique, Québec

080001

Clinica de la Costa, Barranquilla

Unknown

Centro de Investigaciones y Proyectos en Neurociencias CIPNA, Barranquilla

Fundacion Cardiovascular de Colombia, Floridablanca

Centro de Atencion e Investigacion Medica S.A. - CAIMED, Helechos

252 41

Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi, Dolní Břežany

262 03

Res Medica, Nový Knín

323 00

MUDr. Mita Rosenberg, Pilsen

274 01

Nemocnice Slany, Slaný

07747

Universitatsklinikum Jena, Jena

04179

Familienmedizinisches Zentrum Radowsky, Leipzig

00144

Istituto Nazionale Tumori Regina Elena, Roma

00189

Azienda Ospedaliera Sant Andrea, Rome

674 0063

Akashi Medical Center, Akashi Shi

807-0051

Fukuoka Shinmizumaki Hospital, Fukuoka

811-0213

Fukuoka Wajiro Hospital, Fukuoka

040 8611

Hakodate Goryoukaku Hospital, Hakodate

006-8555

Teine Keijinkai Hospital, Hokkaido

820-8501

Aso Co.,Ltd Iizuka Hospital, Iizuka

811-3112

Kano Hospital, Kasuya-gun

211-8510

Kanto Rosai Hospital, Kawasaki

800-0057

Shinkomonji hospital, Kitakyushu

852-8511

JRC Nagasaki Genbaku Hospital, Nagasaki

572-8567

Kyoujinkai Clinic Komatsu, Neyagawa

836-0861

Omuta City Hospital, Omuta-Shi

856-8562

National Hospital Organization Nagasaki Medical Center, Ōmura

006-0812

Teine Maeda Urology Clinic, Sapporo

0060816

Teine Urological Clinic, Sapporo

806-8501

Japan Community Health care Organization Kyushu Hospital, Yahatanishi-ku

750-0041

Shimonoseki City Hospital, Yamaguchi

222-0036

Yokohama Rosai Hospital, Yokohama

245-8575

National Hospital Organization Yokohama Medical Center, Yokohama

2333 ZA

Leiden University Medical Center, Leiden

5406 PT

Ziekenhuis, Uden

3508 GA

The Julius Center - Utrecht Science Park - Stratenum, Utrecht

0600

Southern Clinical Trials Totara Clinical Research, Auckland

0626

Southern Clinical Trials Ltd, Auckland

602 812

Dong-A University Hospital, Busan

501-757

Chunnam National University Hospital, Gwangju

03181

Kangbuk Samsung Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

07441

Hallym University Sacred Heart Hospital, Seoul

07985

Ewha Womans University Mokdong Hospital, Seoul

220-701

WonJu Severance Christian Hospital, Wŏnju

08036

Hosp Clinic de Barcelona, Barcelona

08907

Hosp. Univ. de Bellvitge, Barcelona

07120

Hosp. Univ. Son Espases, Palma de Mallorca

08208

Corporacio Sanitari Parc Tauli, Sabadell

582 13

CTC Ebbepark, Linkoaping

171 64

ClinSmart Sweden AB, Solna

752 37

ClinSmart Sweden AB, Uppsala

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

CV9 1EU

Atherstone Surgery, Atherstone

OX16 9AD

Banbury Cross Health Center, Banbury

CH62 6EE

FutureMeds Bridle Clinic, Birkenhead

B21 0RY

FutureMeds-Soho UK, Birmingham

FY3 8NR

Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

BS10 5NB

North Bristol NHS Trust, Bristol

BS2 8BJ

University Hospitals Bristol NHS Trust, Bristol

EX2 5DW

Royal Devon & Exeter NHS Foundation Trust, Exeter

OX29 4QB

Eynsham Medical Centre, Eynsham

TS14 7DJ

The Garth Surgery, Guisborough

LE1 5WW

University Hospitals Of Leicester Nhs Trust, Leicester

SE5 9RS

King's College Hospital NHS Foundation Trust, London

M13 9WL

Manchester Royal Infirmary, Manchester

M23 9LT

The NIHR Manchester Clinical Research Facility, Manchester

TS4 3BW

South Tees Hospitals NHS Foundation Trust, Middlesbrough

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

PL6 8DH

Plymouth University Hospitals Trust, Plymouth

CF37 2DR

Ashgrove Surgery, Pontypridd

BH15 4JQ

The Adam Practice, Poole

S10 2 JF

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

ST16 3SR

Midlands Partnership NHS Foundation Trust, Stafford

TS19 8PE

North Tees Furturemeds, Stockton-on-Tees

WF1 4DG

Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital, Wakefield

OX12 9BN

Church Street Practice, Wantage

OX28 6JS

Windrush Medical Practice, Witney

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY