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

January 9, 2025 updated by: Janssen Research & Development, LLC

Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With 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

The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes.

Study Overview

Status

Recruiting

Conditions

Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Intervention / Treatment

Detailed Description

Invasive extraintestinal pathogenic Escherichia coli disease (IED) is defined as an acute illness consistent with systemic bacterial infection, which is microbiologically confirmed either by the isolation and identification of Escherichia coli (E. coli) from blood or any other sterile body sites, or by the isolation and identification of E. coli from urine in a participant with urosepsis and no other identifiable source of infection. ExPEC9V (JNJ-78901563, primary compound number: VAC52416) is a 9-valent vaccine candidate in development for active immunization for the prevention of IED in adults 60 years of age and older. Although IED affects all ages, adults aged greater than or equal to (>=) 60 years have an increased risk of developing IED, including bacteremia and sepsis, which can be community-acquired, hospital-acquired or healthcare associated. As the mechanism of action of conjugate vaccines in the prevention of invasive disease is not expected to be affected by antibiotic resistance mechanisms, that is, resistance mechanisms are not linked to O-polysaccharide structures, the sponsor has no reason to expect a difference in outcome of efficacy between antimicrobial-resistant and susceptible O-serotypes. This study incorporates an inferentially seamless group-sequential design. This study consists of a Screening Phase (selected screening procedures may be performed up to 8 days prior to vaccination on Day 1), Randomization, Vaccination Phase (Day 1) and Follow-up Phase (up to 4 years post-vaccination). The total study duration is approximately up to 6 years 9 months. Key safety assessments include serious adverse events (SAEs), solicited and unsolicited adverse events (AEs), physical examination, and vital signs.

Study Type

Interventional

Enrollment (Estimated)

19800

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Study Contact
Phone Number: 844-434-4210
Email: Participate-In-This-Study@its.jnj.com

Study Locations

Australia
- - Brisbane, Australia, 4001
    - Suspended
    - Saint Andrew's War Memorial Hospital
  - Campbelltown, Australia, 5074
    - Completed
    - GP Surgery - Campbelltown
  - Geelong, Australia, 3220
    - Recruiting
    - Barwon Health - University Hospital Geelong
  - Melbourne, Australia, 5000
    - Completed
    - CMAX Clinical Research
  - New Lambton, Australia, 2305
    - Suspended
    - John Hunter Hospital
  - Palmyra DC, Australia, 6961
    - Recruiting
    - Fiona Stanley Hospital
  - Para Hills West, Australia, 5096
    - Completed
    - McIntyre Medical Center
  - Salisbury, Australia, 5108
    - Completed
    - North West Medical Center
  - South Brisbane, Australia, 4101
    - Completed
    - Mater Medical Centre South Brisbane
  - St Agnes, Australia, 5097
    - Completed
    - Bene Aged Care - Italian Village
  - Sydney, Australia, 2145
    - Recruiting
    - Westmead Hospital
  - Taringa, Australia, 4068
    - Completed
    - AusTrials Pty Ltd
  - Tarragindi, Australia, 4121
    - Completed
    - AusTrials Pty Ltd
  - Woodville, Australia, 5011
    - Completed
    - Adelaide Medical Solutions
Canada
- - Quebec, Canada, G3K 2P8
    - Recruiting
    - Alpha Recherche Clinique
  - Quebec, Canada, G2J 0C4
    - Recruiting
    - Alpha Recherche Clinique
- Alberta
  - Calgary, Alberta, Canada, T4P 1K4
    - Recruiting
    - CARe Clinical Ltd
  - Edmonton, Alberta, Canada, T6G121
    - Completed
    - University of Alberta
  - Red Deer, Alberta, Canada, T4P 1K4
    - Recruiting
    - CARe Clinical Ltd
- British Columbia
  - Vancouver, British Columbia, Canada, V6Z2C7
    - Suspended
    - Vancouver ID Research and Care Centre Society
- Ontario
  - Guelph, Ontario, Canada, N1H 1B1
    - Suspended
    - Dawson Road Family Health Team
  - Sarnia, Ontario, Canada, N7T 4X3
    - Recruiting
    - Bluewater Clinical Research Group Inc.
  - Sudbury, Ontario, Canada, P3E 5J1
    - Suspended
    - Health Sciences North
  - Winchester, Ontario, Canada, K0C2K0
    - Recruiting
    - Winchester District Memorial Hospital
China
- - Chengdu, China, 610041
    - Recruiting
    - West China School of Medicine/West China Hospital, Sichuan University
  - Fuyang, China, 236399
    - Suspended
    - Funan Center for Disease Control and Prevention
  - Guangzhou, China, 510120
    - Recruiting
    - The First Affiliated Hospital of Guangzhou Medical University
  - Guangzhou, China, 510260
    - Recruiting
    - The Second Affiliated Hospital of Guangzhou Medical University
  - Hangzhou, China, 310003
    - Recruiting
    - 1st Affiliated Hospital of Zhejiang University Medical College
  - Hefei, China, 230601
    - Suspended
    - Anhui Provincial Center for Disease Control and Prevention
  - Liuan, China, 237400
    - Suspended
    - Huoqiu County Center For Disease Control and Prevention
  - Nanjing, China, 211112
    - Recruiting
    - Nanjing Medical University
  - Nanjing, China, 210009
    - Suspended
    - Jiangsu Provincial Center for Disease Control and Prevention
  - Shanghai, China, 200040
    - Recruiting
    - Huashan Hospital Affiliated to Fudan University
  - Suzhou, China, 215002
    - Recruiting
    - Suzhou Municipal Hospital
  - Taizhou, China, 225300
    - Suspended
    - Taizhou Peoples Hospital
  - Wuxi, China, 214200
    - Suspended
    - Yixing People's Hospital
Colombia
- - Barranquilla, Colombia, 080001
    - Recruiting
    - Clinica De La Costa
  - Barranquilla, Colombia, 80020
    - Recruiting
    - IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
  - Barranquilla, Colombia
    - Suspended
    - Centro de Investigaciones y Proyectos en Neurociencias CIPNA
  - Casanare, Colombia, 856010
    - Suspended
    - Centro de Atencion e Investigacion Medica S.A. - CAIMED
  - Floridablanca, Colombia
    - Suspended
    - Fundación Cardiovascular de Colombia
  - Girardot, Colombia, 252432
    - Suspended
    - Centro de Atencion e Investigacion Medica S.A. - CAIMED
  - Helechos, Colombia
    - Recruiting
    - Centro de Atencion e Investigacion Medica S.A. - CAIMED
  - Manizales, Colombia, 170001
    - Suspended
    - Asociacion IPS Medicos Internistas de Caldas
  - Meta, Colombia, 507001
    - Suspended
    - CAIMED Acacias
  - Pereira, Colombia, 660003
    - Suspended
    - Fundacion Centro de Investigaciones Clinicas IPS Cardiomet
  - Villavicencio, Colombia, 500001
    - Suspended
    - Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc
Czechia
- - Brno, Czechia, 61500
    - Recruiting
    - Uromeda
  - Ceske Budejovice, Czechia, 37001
    - Recruiting
    - Ordinace Hradebni s.r.o.
  - Dolni Brezany, Czechia, 252 41
    - Suspended
    - Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi
  - Hradec Kralove, Czechia, 50002
    - Recruiting
    - Centrum Ockovani a Cestovi Mediciny
  - Novy Knin, Czechia, 262 03
    - Recruiting
    - Res Medica
  - Olomouc, Czechia, 77900
    - Recruiting
    - PreventaMed, s.r.o.
  - Ostrava-Proskovice, Czechia, 72400
    - Recruiting
    - GYNURO s.r.o
  - Plzen 1, Czechia, 323 00
    - Completed
    - MUDr. Mita Rosenberg
  - Plzeň, Czechia, 30100
    - Recruiting
    - Ambulance name: Gynekologická ordinace MUDr
  - Praha 3, Czechia, 13000
    - Recruiting
    - Gona s.R.o- Orfinace Harov
  - Protivin, Czechia, 39811
    - Recruiting
    - Zdravi-fit, s.r.o.
  - Slany, Czechia, 274 01
    - Recruiting
    - Nemocnice Slany
  - Vysoke Myto, Czechia, 56601
    - Suspended
    - Progerint s.r.o.
Denmark
- - Hellerup, Denmark, 2900
    - Recruiting
    - Aalborg Universitetshospital Nord
  - Herlev, Denmark, 2730
    - Recruiting
    - Gentofte Hospital
  - Herlev, Denmark, 2730
    - Suspended
    - Gentofte Hospital
  - Hilleroed, Denmark, 3400
    - Recruiting
    - Nordsjaellands Hospital - Hillerod
  - Hvidovre, Denmark, 2650
    - Recruiting
    - Hvidovre hospital
  - Odense M, Denmark, 5230
    - Recruiting
    - Odense Universitetshospital
  - Roskilde, Denmark, 4000
    - Recruiting
    - Sjællands University hospital
France
- - Dijon, France, 21000
    - Recruiting
    - CHU Dijon Bourgogne - Hopital Francois Mitterrand
  - Limousis, France, 87042
    - Recruiting
    - CHU de Limoges
  - Lyon, France, 69004
    - Recruiting
    - Hopital de la croix rousse
  - Nîmes, France, 30029
    - Recruiting
    - CHU Nimes Hopital Caremeau
  - Pierre Benite cedex, France, 69495
    - Recruiting
    - Centre Hospitalier Lyon-Sud
  - Saint-Priest en Jarez, France, 42270
    - Recruiting
    - CHU Saint Etienne Hopital Nord
Germany
- - Frankfurt, Germany, 60590
    - Recruiting
    - Universitätsklinikum Frankfurt
  - Jena, Germany, 07747
    - Recruiting
    - Universitätsklinikum Jena
  - Leipzig, Germany, 04179
    - Recruiting
    - Familienmedizinisches Zentrum Radowsky
  - Leipzig, Germany, 4103
    - Suspended
    - SIBAmed GmbH & Co. KG
  - Marburg, Germany, 35037
    - Recruiting
    - Universitaetsklinikum Giessen und Marburg GmbH
  - Oldenburg in Holstein, Germany, 23758
    - Recruiting
    - Red-Institut für medizinische Forschung und Fortbildung
  - Reinfeld, Germany, 23858
    - Recruiting
    - Praxis Dr. Weimer
  - Rostock, Germany, 18057
    - Recruiting
    - Universitaetsmedizin Rostock
India
- - Belagavi, India, 590010
    - Recruiting
    - KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)
  - Jaipur, India, 302006
    - Recruiting
    - S. R. Kalla Memorial General Hospital
  - Kolkata, India, 700014
    - Recruiting
    - Nil Ratan Sircar Medical College and Hospital
  - Lucknow, India, 226022
    - Recruiting
    - Regency health super specialty hospital
  - Mumbai, India, 421203
    - Recruiting
    - Asian Institute Of Medical Science
  - Mysuru, India, 570015
    - Recruiting
    - Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research
  - New Delhi, India, 1100776
    - Recruiting
    - Indraprastha Apollo Hospital
  - Rajkot, India, 360004
    - Recruiting
    - Shree Giriraj Multispeciality Hospital
  - Surat, India, 395002
    - Recruiting
    - Nirmal Hospital Pvt. Ltd.
  - Surat, India, 395009
    - Recruiting
    - BAPS Pramukhswami Hospital
Israel
- - Ashdod, Israel, 7747629
    - Recruiting
    - Samson Assuta Ashdod University Hospital
  - Jerusalem, Israel, 9112001
    - Recruiting
    - Hadassah Medical Center
  - Kfar Saba, Israel, 44281
    - Recruiting
    - Meir Medical Center
  - Ramat Gan, Israel, 52621
    - Recruiting
    - The Chaim Sheba Medical Center
  - Tel Aviv Yafo, Israel, 6423906
    - Recruiting
    - Tel Aviv Sourasky Medical Center
Italy
- - Chieti, Italy, 66100
    - Completed
    - ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
  - Roma, Italy, 00144
    - Completed
    - Istituto Nazionale Tumori Regina Elena
  - Rome, Italy, 00189
    - Completed
    - Azienda Ospedaliera Sant Andrea
Japan
- - Akashi shi, Japan, 674 0063
    - Recruiting
    - Akashi Medical Center
  - Fukuoka, Japan, 807-0051
    - Recruiting
    - Fukuoka Shinmizumaki Hospital
  - Fukuoka-Shi, Japan, 811-0213
    - Recruiting
    - Fukuoka Wajiro Hospital
  - Hakodate, Japan, 040-8611
    - Recruiting
    - Hakodate Goryoukaku Hospital
  - Hashima-gun, Japan, 5016062
    - Recruiting
    - Matsunami General Hospital
  - Hokkaido, Japan, 006-8555
    - Recruiting
    - Teine Keijinkai Hospital
  - Iizuka, Japan, 820-8501
    - Recruiting
    - Aso Co.,Ltd Iizuka Hospital
  - Itoshima-City, Japan, 8191104
    - Recruiting
    - Inoue Hospital
  - Kasuya-gun, Japan, 811-3112
    - Recruiting
    - Kano Hospital
  - Kawasaki, Japan, 211-8510
    - Recruiting
    - Kanto Rosai Hospital
  - Kitakyushu, Japan, 8000295
    - Recruiting
    - Japan Community Health care Organization Kyushu Hospital
  - Kitakyusyu, Japan, 800-0057
    - Recruiting
    - Shinkomonji hospital
  - Nagasaki-Shi, Japan, 852-8511
    - Recruiting
    - JRC Nagasaki Genbaku Hospital
  - Neyagawa, Japan, 572-8567
    - Recruiting
    - Kyoujinkai Clinic Komatsu
  - Oita, Japan, 8700039
    - Recruiting
    - Abe Diabetes Clinic
  - Oita, Japan, 8701195
    - Recruiting
    - Almeida Memorial Hospital
  - Omura, Japan, 856-8562
    - Recruiting
    - National Hospital Organization Nagasaki Medical Center
  - Omuta-Shi, Japan, 836-0861
    - Recruiting
    - Omuta City Hospital
  - Osaka City, Japan, 5530003
    - Recruiting
    - Japan Community Health Care Organization Osaka Hospital
  - Osaka-shi, Japan, 5340024
    - Recruiting
    - Kyobashi Sugimoto Clinic
  - Sanuki, Japan, 7692393
    - Recruiting
    - National Hospital Organization Shikoku Cancer Center
  - Sapporo-Shi, Japan, 006-0812
    - Recruiting
    - Teine Maeda Urology Clinic
  - Sapporo-Shi, Japan, 0060816
    - Recruiting
    - Teine Urological Clinic
  - Shimajiri-Gun, Japan, 9010493
    - Recruiting
    - Nanbu Tokushukai Hospital
  - Shimonoseki-shi, Japan, 7500061
    - Recruiting
    - Shimonoseki City Hospital
  - Shinagawa City, Japan, 1408522
    - Recruiting
    - Tokyo Shinagawa Hospital
  - Suita-Shi, Japan, 5650814
    - Recruiting
    - Suita Tokushukai Hospital
  - Suwa-Shi, Japan, 3928510
    - Recruiting
    - Japanese Red Cross Society Suwa Hospital
  - Yahatanishi-ku, Japan, 806-8501
    - Recruiting
    - Japan Community Health care Organization Kyushu Hospital
  - Yamaguchi, Japan, 750-0041
    - Recruiting
    - Shimonoseki City Hospital
  - Yokohama, Japan, 245-8575
    - Recruiting
    - National Hospital Organization Yokohama Medical Center
  - Yokohama, Japan, 222-0036
    - Recruiting
    - Yokohama Rosai Hospital
Korea, Republic of
- - Busan, Korea, Republic of, 602 812
    - Recruiting
    - Dong-A University Hospital
  - ChunCheon, Korea, Republic of, 24253
    - Completed
    - Hallym University Chuncehon Medical Center
  - Daejeon, Korea, Republic of, 35015
    - Recruiting
    - Chungnam National University Hospital
  - Gwangju, Korea, Republic of, 501-757
    - Recruiting
    - Chunnam National University Hospital
  - Gyeonggi-do, Korea, Republic of, 15355
    - Recruiting
    - Korea University Ansan Hospital
  - Incheon, Korea, Republic of, 22322
    - Recruiting
    - Inha University Hospital
  - Seongnam-si, Korea, Republic of, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 06351
    - Recruiting
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 03181
    - Recruiting
    - Kangbuk Samsung Hospital
  - Seoul, Korea, Republic of, 05505
    - Completed
    - Asan Medical Center
  - Seoul, Korea, Republic of, 07985
    - Completed
    - Ewha Womans University Mokdong Hospital
  - Seoul, Korea, Republic of, 07441
    - Recruiting
    - Hallym University Sacred Heart Hospital
  - Seoul Teugbyeolsi, Korea, Republic of, 8308
    - Recruiting
    - Korea University Guro Hospital
  - Suwon-si, Korea, Republic of, 16247
    - Recruiting
    - The Catholic university of Korea, St. Vincent's Hospital
  - Wonju, Korea, Republic of, 220-701
    - Completed
    - Wonju Severance Christian Hospital
Netherlands
- - Leiden, Netherlands, 2333 ZA
    - Recruiting
    - Leiden University Medical Center
  - Uden, Netherlands, 5406 PT
    - Recruiting
    - Ziekenhuis
  - Utrecht, Netherlands, 3508 GA
    - Recruiting
    - The Julius Center - Utrecht Science Park - Stratenum
New Zealand
- - Auckland, New Zealand, 0600
    - Recruiting
    - Southern Clinical Trials Totara Clinical Research
  - Auckland, New Zealand, 0626
    - Recruiting
    - Southern Clinical Trials Ltd
  - Auckland, New Zealand, 1011
    - Recruiting
    - Optimal Clinical Trials
  - Bay Of Plenty, New Zealand, 3112
    - Recruiting
    - Tauranga Urology Research Limited
  - Christchurch, New Zealand, 8013
    - Recruiting
    - Canterbury Urology Research Trust
  - Christchurch Central, New Zealand, 8013
    - Recruiting
    - Southern Clinical Trials Ltd
  - Dunedin, New Zealand, 9016
    - Recruiting
    - P3 Research Ltd
  - Hamilton, New Zealand, 3200
    - Recruiting
    - Lakeland Clinical Trials
  - Hastings, New Zealand, 4122
    - Recruiting
    - P3 Research Ltd
  - Lower Hutt, New Zealand, 5010
    - Recruiting
    - P3 Research - Lower Hutt
  - Nelson, New Zealand, 7011
    - Recruiting
    - Southern Clinical Trials Ltd
  - Palmerston North, New Zealand, 4414
    - Recruiting
    - P3 Research Ltd
  - Papamoa, New Zealand, 3118
    - Recruiting
    - Culloden Research Ltd
  - Papatoetoe, New Zealand, 2025
    - Recruiting
    - Middlemore Clinical Trials
  - Rosedale, New Zealand, 632
    - Recruiting
    - Optimal Clinical Trials
  - Rotorua, New Zealand, 3010
    - Recruiting
    - Lakeland Clinical Trials
  - Tauranga, New Zealand, 3110
    - Recruiting
    - P3 Research Ltd
  - Upper Hutt, New Zealand, 5018
    - Recruiting
    - Lakeland Clinical Trials
  - Wellington, New Zealand, 5032
    - Recruiting
    - P3 Research Limited Kapiti
  - Wellington, New Zealand, 6242
    - Recruiting
    - Capatial & Coast District Health Board
Spain
- - Barcelona, Spain, 08907
    - Recruiting
    - Hosp. Univ. de Bellvitge
  - Barcelona, Spain, 8003
    - Completed
    - Hosp. Del Mar
  - Barcelona, Spain, 8028
    - Recruiting
    - Consorci D'Atenció Primària de Salut Barcelona Esquerra
  - Barcelona, Spain, 08036
    - Recruiting
    - Hosp Clinic de Barcelona
  - Córdoba, Spain, 14004
    - Recruiting
    - Hosp Reina Sofia
  - Girona, Spain, 17007
    - Suspended
    - Hosp. Univ. Dr. Josep Trueta
  - Jerez de la Frontera, Spain, 11407
    - Recruiting
    - Hosp. de Jerez de La Frontera
  - La Roca del Valles, Spain, 8430
    - Completed
    - CAP Dr. Vicenç Papaceit ABS LA ROCA
  - Madrid, Spain, 28006
    - Recruiting
    - Hosp. Univ. de La Princesa
  - Madrid, Spain, 28046
    - Recruiting
    - Hosp. Univ. La Paz
  - Madrid, Spain, 28050
    - Recruiting
    - Hospital Sanitas La Moraleja
  - Madrid, Spain, 28660
    - Suspended
    - Hosp. Univ. Hm Monteprincipe
  - Málaga, Spain, 29004
    - Completed
    - Hosp. Quirónsalud Málaga
  - Ourense, Spain, 32005
    - Completed
    - Complexo Hosp. Univ. de Ourense
  - Palma de Mallorca, Spain, 07120
    - Recruiting
    - Hosp. Univ. Son Espases
  - Sabadell, Spain, 08208
    - Recruiting
    - Corporacio Sanitari Parc Tauli
  - Sevilla, Spain, 41009
    - Recruiting
    - Hosp. Virgen Macarena
  - Vigo, Spain, 36312
    - Recruiting
    - Hosp. Alvaro Cunqueiro
Sweden
- - Helsingborg, Sweden, 25187
    - Recruiting
    - Helsingborgs Lasarett
  - Karlskrona, Sweden, 37179
    - Suspended
    - BTH Research & Development Clinic
  - Linkoaping, Sweden, 582 13
    - Recruiting
    - CTC Ebbepark
  - Malmoe, Sweden, 21428
    - Recruiting
    - Skanes universitetssjukhus
  - Solna, Sweden, 171 64
    - Suspended
    - ClinSmart Sweden AB
  - Uppsala, Sweden, 752 37
    - Recruiting
    - ClinSmart Sweden AB
  - Örebro, Sweden, 70362
    - Suspended
    - Universitetssjukhuset Orebro
Taiwan
- - Kaohsiung, Taiwan, 813
    - Recruiting
    - Kaohsiung Veterans General Hospital
  - Tainan, Taiwan, 704
    - Recruiting
    - National Cheng Kung University Hospital
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Chang Gung Memorial Hospital Linkou Branch
Thailand
- - Bangkok, Thailand, 10700
    - Recruiting
    - Siriraj Hospital
  - Bangkok, Thailand, 10330
    - Recruiting
    - King Chulalongkorn Memorial Hospital
  - Bangkok, Thailand, 10330
    - Recruiting
    - Thai Red Cross AIDS Research Centre
  - Bangkok, Thailand, 10400
    - Recruiting
    - Tropical Medicine Hospital, Mahidol University
  - Bangkok, Thailand, 10400
    - Suspended
    - Ramathibodi Hospital
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Recruiting
    - Aberdeen Royal Infirmary
  - Atherstone, United Kingdom, CV9 1EU
    - Completed
    - Atherstone Surgery
  - Banbury, United Kingdom, OX16 9AD
    - Recruiting
    - Banbury Cross Health Center
  - Birkenhead, United Kingdom, CH62 6EE
    - Recruiting
    - FutureMeds Bridle Clinic
  - Birmingham, United Kingdom, B21 0RY
    - Recruiting
    - FutureMeds-Soho UK
  - Blackpool, United Kingdom, FY3 8NR
    - Recruiting
    - Blackpool Teaching Hospitals NHS Foundation Trust
  - Bournemouth, United Kingdom, BH7 7DW
    - Recruiting
    - Royal Bournemouth Hospital
  - Bristol, United Kingdom, BS2 8BJ
    - Recruiting
    - University Hospitals Bristol NHS Trust
  - Bristol, United Kingdom, BS10 5NB
    - Suspended
    - North Bristol NHS Trust
  - Exeter, United Kingdom, EX2 5DW
    - Suspended
    - Royal Devon & Exeter NHS Foundation Trust
  - Eynsham, United Kingdom, OX29 4QB
    - Recruiting
    - Eynsham Medical Centre
  - Guisborough, United Kingdom, TS14 7DJ
    - Suspended
    - The Garth Surgery
  - Leicester, United Kingdom, LE1 5WW
    - Suspended
    - University Hospitals of Leicester NHS Trust
  - London, United Kingdom, SE5 9RS
    - Recruiting
    - King's College Hospital NHS Foundation Trust
  - Manchester, United Kingdom, M13 9WL
    - Completed
    - Manchester Royal Infirmary
  - Manchester, United Kingdom, M23 9LT
    - Recruiting
    - The NIHR Manchester Clinical Research Facility
  - Middlesbrough, United Kingdom, TS4 3BW
    - Recruiting
    - South Tees Hospitals NHS Foundation Trust
  - Nottingham, United Kingdom, NG7 2UH
    - Recruiting
    - Nottingham University Hospitals NHS Trust
  - Plymouth, United Kingdom, PL6 8DH
    - Completed
    - Plymouth University Hospitals Trust
  - Pontypridd, United Kingdom, CF37 2DR
    - Recruiting
    - Ashgrove Surgery
  - Poole, United Kingdom, BH15 4JQ
    - Recruiting
    - The Adam Practice
  - Sheffield, United Kingdom, S10 2 JF
    - Recruiting
    - Sheffield Teaching Hospitals NHS Foundation Trust
  - Stafford, United Kingdom, ST16 3SR
    - Recruiting
    - Midlands Partnership NHS Foundation Trust
  - Stockton-on-Tees, United Kingdom, TS19 8PE
    - Recruiting
    - North Tees Furturemeds
  - Wakefield, United Kingdom, WF1 4DG
    - Suspended
    - Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
  - Wantage, United Kingdom, OX12 9BN
    - Recruiting
    - Church Street Practice
  - Witney, United Kingdom, OX28 6JS
    - Recruiting
    - Windrush Medical Practice
United States
- Alabama
  - Guntersville, Alabama, United States, 35976
    - Recruiting
    - Lakeview Clinical Research
- Arizona
  - Phoenix, Arizona, United States, 85018
    - Recruiting
    - Hope Research Institute
  - Phoenix, Arizona, United States, 85108
    - Suspended
    - Hope Research Institute
  - Sun City West, Arizona, United States, 85357
    - Recruiting
    - Interspond-Clinical Research Institute of AZ
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Suspended
    - Baptist Health Center for Clinical Research
- California
  - Buena Park, California, United States, 90621
    - Suspended
    - Sun Urology - Buena Park Office
  - Canoga Park, California, United States, 91303
    - Suspended
    - Hope Clinical Research LLC
  - Chula Vista, California, United States, 91911
    - Recruiting
    - Velocity Clinical Research, Inc.
  - Huntington Beach, California, United States, 92647
    - Suspended
    - Marvel Clinical Research
  - La Mesa, California, United States, 91942
    - Recruiting
    - California Adult Circumcision - Alvarado La Mesa Urology Center
  - Lancaster, California, United States, 93534
    - Completed
    - Om Research LLC
  - Long Beach, California, United States, 90806
    - Recruiting
    - Long Beach Clinical Trials, LLC
  - Long Beach, California, United States, 90806-2766
    - Suspended
    - Atlantic Urology Medical Group
  - Los Angeles, California, United States, 90027
    - Recruiting
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90027
    - Recruiting
    - Southern California Permanente Medical Group
  - Los Angeles, California, United States, 90073
    - Recruiting
    - Veterans Affairs Greater Los Angeles HCS
  - Los Angeles, California, United States, 90048
    - Suspended
    - Comprehensive Urology
  - Los Angeles, California, United States, 90017
    - Suspended
    - American Institute of Research
  - Mather, California, United States, 95655
    - Recruiting
    - VA Sacramento Medical Center
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Hoag Medical Group
  - Pomona, California, United States, 91767
    - Suspended
    - Empire Clinical Research, LLC
  - Pomona, California, United States, 91767
    - Suspended
    - Inland Urology Medical Group
  - Sacramento, California, United States, 92647
    - Recruiting
    - UC Davis Health System
  - Sacramento, California, United States, 95821
    - Suspended
    - Northern California Research
  - San Diego, California, United States, 92123
    - Completed
    - Medical Associates Research Group, Inc.
  - San Diego, California, United States, 92120
    - Suspended
    - San Diego Sports Medicine & Family Health Center
  - San Dimas, California, United States, 91773
    - Completed
    - California Kidney Specialists
  - Santa Ana, California, United States, 92705
    - Suspended
    - Prestige Medical Group
  - Simi Valley, California, United States, 93065
    - Suspended
    - Millennium Clinical Trials LLC
  - Upland, California, United States, 91786
    - Suspended
    - San Antonio Regional Hospital
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Recruiting
    - Yale University
- Florida
  - Adventura, Florida, United States, 33180
    - Suspended
    - Ideal Clinical Research
  - Bay Pines, Florida, United States, 33744
    - Recruiting
    - Bay Pines VA Healthcare System
  - Bradenton, Florida, United States, 34209
    - Recruiting
    - Nova Clinical Research, LLC
  - Brandon, Florida, United States, 33511
    - Recruiting
    - Clinical Research of Brandon
  - Brandon, Florida, United States, 33511
    - Suspended
    - Moore Clinical Reseach - Brandon Clinic
  - Clearwater, Florida, United States, 33756
    - Suspended
    - Innovative Research of West Florida, Incorporated
  - Clearwater, Florida, United States, 33755
    - Suspended
    - Florida Medical Center of Clearwater
  - Coral Gables, Florida, United States, 33134
    - Suspended
    - Advanced Clinical Research Network
  - Coral Gables, Florida, United States, 33134
    - Suspended
    - Prestige Clinical Research Center, Inc.
  - DeLand, Florida, United States, 32720
    - Suspended
    - Accel Research Sites
  - Doral, Florida, United States, 33166
    - Completed
    - Universal Axon Clinical Research
  - Doral, Florida, United States, 33166
    - Suspended
    - Doral Medical Research
  - Gainesville, Florida, United States, 32607
    - Recruiting
    - Florida Medical Research Institute
  - Hialeah, Florida, United States, 33012
    - Suspended
    - Indago Research & Health Center Inc
  - Homestead, Florida, United States, 33030
    - Suspended
    - Prestige Clinical Research
  - Lake City, Florida, United States, 32055
    - Suspended
    - Multi Specialty Research Associates Inc
  - Maitland, Florida, United States, 32751
    - Suspended
    - ClinCloud Clinical Research
  - Miami, Florida, United States, 33185
    - Suspended
    - Felicidad Medical Research
  - Miami, Florida, United States, 33126
    - Suspended
    - Finlay Medical Research
  - Miami, Florida, United States, 33133
    - Suspended
    - Royal Care Medical Research Corporation
  - Miami, Florida, United States, 33135
    - Suspended
    - Retreat Medical Research LLC
  - Miami, Florida, United States, 33135
    - Suspended
    - Suncoast Research Group
  - Miami, Florida, United States, 33144
    - Suspended
    - Dynamic Medical Research, LLC
  - Miami, Florida, United States, 33155
    - Suspended
    - Florida International Medical Research
  - Miami, Florida, United States, 33155
    - Suspended
    - Health- Life Research Inst
  - Miami, Florida, United States, 33124
    - Suspended
    - Nova Clinical Research Center
  - Miami, Florida, United States, 33155
    - Suspended
    - Office of Dr. Marisela Gonzalez
  - Miami, Florida, United States, 33144-4273
    - Suspended
    - Continental Research
  - Miami, Florida, United States, 33186
    - Suspended
    - Alpha Science Research
  - Miami, Florida, United States, 33186
    - Suspended
    - A and R Research Group
  - Orlando, Florida, United States, 32801
    - Recruiting
    - Clinical NeuroScience Solutions Inc
  - Orlando, Florida, United States, 32808
    - Suspended
    - Omega Research Consultants
  - Pembroke Pines, Florida, United States, 33024
    - Suspended
    - Pines Care Research Center Inc
  - Plant City, Florida, United States, 33563
    - Recruiting
    - Clinical Research of Central Florida
  - Spring Hill, Florida, United States, 34609
    - Completed
    - Care Access Research
  - Tampa, Florida, United States, 33603
    - Recruiting
    - Tampa General Hospital
  - Tampa, Florida, United States, 33614
    - Recruiting
    - Precision Research Institute
  - Tampa, Florida, United States, 33615
    - Recruiting
    - Santos Research Center
  - Tampa, Florida, United States, 33613
    - Recruiting
    - Theia Clincial Research, LLC
  - Tampa, Florida, United States, 33614
    - Completed
    - St. Joseph's Comprehensive Research Institute
  - Tampa, Florida, United States, 33625
    - Suspended
    - Care Access Research
- Georgia
  - Atlanta, Georgia, United States, 30328
    - Completed
    - Agile Clinical Research Trials, LLC
  - Columbus, Georgia, United States, 31904
    - Recruiting
    - Columbus Regional Research Institute
  - Decatur, Georgia, United States, 30033
    - Recruiting
    - Atlanta VA Medical Center
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Recruiting
    - Snake River Research, PLLC
  - Idaho Falls, Idaho, United States, 83404
    - Completed
    - Clinical Research Prime
- Illinois
  - Chicago, Illinois, United States, 60612
    - Suspended
    - University of Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
  - Chicago, Illinois, United States, 60612
    - Suspended
    - Jesse Brown VAMC Department of Surgery
- Indiana
  - Evansville, Indiana, United States, 47714
    - Recruiting
    - MediSphere Medical Research Center, LLC
  - Hammond, Indiana, United States, 46324
    - Suspended
    - Asha Clinical Research-Munster Llc
  - Mishawaka, Indiana, United States, 46544
    - Recruiting
    - Mishawaka Osteopathic Clinic/MOC Research
- Kansas
  - Wichita, Kansas, United States, 67226
    - Completed
    - Cypress Medical Research Center
- Louisiana
  - Marrero, Louisiana, United States, 70072
    - Recruiting
    - Tandem Clinical Research
  - Natchitoches, Louisiana, United States, 71457
    - Suspended
    - KAMP Medical Research, Inc
  - New Orleans, Louisiana, United States, 70121
    - Recruiting
    - Ochsner Medical Center
- Maryland
  - Rockville, Maryland, United States, 20852
    - Recruiting
    - Kaiser Permanente
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Suspended
    - Floating Hospital For Children at Tufts Medical Center
  - West Roxbury, Massachusetts, United States, 02132-4927
    - Recruiting
    - West Roxbury Veterans Affairs Medical Center
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Hospital
  - Royal Oak, Michigan, United States, 48073
    - Recruiting
    - William Beaumont Hospital
- Mississippi
  - Petal, Mississippi, United States, 39465
    - Completed
    - MediSync Clinical Research
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Recruiting
    - Meridian Clinical Research, LLC
  - Lincoln, Nebraska, United States, 68516
    - Recruiting
    - Be Well Clinical Studies
  - Norfolk, Nebraska, United States, 68701
    - Recruiting
    - Meridian Clinical Research, LLC
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Completed
    - Hope Research Institute
  - Las Vegas, Nevada, United States, 89106
    - Suspended
    - Sierra Clinical Research
  - Las Vegas, Nevada, United States, 89109
    - Suspended
    - Excel Clinical Research
  - Reno, Nevada, United States, 89509
    - Completed
    - VA Sierra Nevada Health Care System
- New Jersey
  - Hillsborough, New Jersey, United States, 08844
    - Suspended
    - I.D. Care, Inc.
- New York
  - Binghamton, New York, United States, 13901
    - Recruiting
    - Meridian Clinical Research, LLC
  - Bronx, New York, United States, 10467
    - Recruiting
    - Montefiore Medical Center
  - Endwell, New York, United States, 13760
    - Suspended
    - Meridian Clinical Research, LLC
  - New York, New York, United States, 10016
    - Completed
    - Manhattan Medical Research
- North Carolina
  - Durham, North Carolina, United States, 27705
    - Recruiting
    - Durham VAMC
  - Fayetteville, North Carolina, United States, 28303
    - Suspended
    - Carolina Institute for Clinical Research
  - Greenville, North Carolina, United States, 27834
    - Recruiting
    - ECU Health Vidant Medical Center
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Recruiting
    - Plains Clinical Research
- Ohio
  - Centerville, Ohio, United States, 45458
    - Recruiting
    - Kroger Health
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - University Hospitals Cleveland Medical Center
  - Columbus, Ohio, United States, 43215
    - Recruiting
    - Remington Davis Inc
  - Englewood, Ohio, United States, 45322
    - Recruiting
    - Kroger Health
  - Englewood, Ohio, United States, 45322
    - Recruiting
    - The Little Clinic
  - Wooster, Ohio, United States, 44691
    - Completed
    - Comprehensive Internal Medicine
- Oklahoma
  - Yukon, Oklahoma, United States, 73099
    - Suspended
    - Tekton Research Inc.
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - Recruiting
    - Capital Area Research
  - West Reading, Pennsylvania, United States, 19611
    - Recruiting
    - Reading Hospital
- South Carolina
  - Charleston, South Carolina, United States, 29412
    - Suspended
    - Hugh D. Durrence, MD, PC
  - Little River, South Carolina, United States, 29566
    - Recruiting
    - Waterway Familiy Medicine
- Texas
  - Bellaire, Texas, United States, 77401
    - Recruiting
    - Novel Research LLC
  - Dallas, Texas, United States, 75246
    - Recruiting
    - North Texas Infectious Diseases Consultants
  - Dallas, Texas, United States, 75224
    - Completed
    - Global Medical Research - Dallas
  - Dallas, Texas, United States, 75230
    - Suspended
    - Medical City Dallas
  - Houston, Texas, United States, 77024
    - Suspended
    - Digestive Health Associates
  - Lewisville, Texas, United States, 75057
    - Completed
    - EPIC Clinical Research
  - Mesquite, Texas, United States, 75149
    - Recruiting
    - SMS Clinical Research LLC
  - Round Rock, Texas, United States, 78681
    - Recruiting
    - Be Well Clinical Studies
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Audie L Murphy Memorial Va Ho
  - Sherman, Texas, United States, 75092
    - Suspended
    - Sherman Clinical Research
- Utah
  - Draper, Utah, United States, 84020
    - Completed
    - Lone Peak Family Medicine
- Virginia
  - Annandale, Virginia, United States, 22003-7347
    - Recruiting
    - Clinical Alliance for Research and Education
  - Charlottesville, Virginia, United States, 22911
    - Suspended
    - Charlottesville Medical Research Center, LLC
  - Lynchburg, Virginia, United States, 24501
    - Recruiting
    - Infectious Disease Associates of Central Virginia
  - Suffolk, Virginia, United States, 23435
    - Suspended
    - IACT - Suffolk Multispecialty Research
  - Winchester, Virginia, United States, 22601
    - Suspended
    - Selma Medical Associates
- Washington
  - Cheney, Washington, United States, 99004
    - Recruiting
    - Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney
- West Virginia
  - Morgantown, West Virginia, United States, 26505
    - Suspended
    - Exemplar Research, Inc
- Wisconsin
  - Marshfield, Wisconsin, United States, 54449
    - Recruiting
    - Marshfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Participant must be willing to share relevant medical information pertaining to medical history and to share medical records relevant to the medical events identified as suspected cases of invasive extraintestinal pathogenic Escherichia coli disease (IED), urinary tract infections (UTI), or acute bacterial prostatitis (ABP) occurring during the study observation period
Participant must have a history of UTI in the past 2 years for which evidence of diagnosis was verified by the investigator. In case of a recent history of UTI or ABP, the condition must have resolved greater than (>)14 days prior to randomization
Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and not intending to conceive by any methods
Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study

Exclusion Criteria:

Participant has end-stage renal disease for which dialysis is required
Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws
Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy
Participant has received any Escherichia coli (E. coli) or extraintestinal pathogenic Escherichia coli (ExPEC) vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ExPEC9V Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.	Biological: ExPEC9V ExPEC9V will be administered as an IM injection. Other Names: VAC52416, JNJ-78901563
Placebo Comparator: Placebo Participants will receive a single IM injection of matching placebo on Day 1.	Other: Placebo Matching placebo will be administered as an IM injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with First Invasive Extraintestinal Pathogenic E.coli Disease (IED) Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (ExPEC9V) O-serotypes Time Frame: Up to 4 years	Number of participants with first IED event with microbiological confirmation in blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes will be reported.	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with First Urinary Tract Infection (UTI) Event Caused by ExPEC9V O-serotypes Time Frame: Up to 3 years	Number of participants with first UTI event caused by ExPEC9V O-serotypes will be reported.	Up to 3 years
Number of Participants with Solicited Local Adverse Events (AEs) Time Frame: Up to Day 15 (until 14 days post-vaccination)	Number of participants with solicited local AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs. Participants will be asked to note in the diary occurrences of injection site pain/tenderness, erythema and swelling at the study vaccine injection site daily for 14 days post-vaccination (day of vaccination and the subsequent 14 days).	Up to Day 15 (until 14 days post-vaccination)
Number of Participants with Solicited Systemic AEs Time Frame: Up to Day 15 (until 14 days post-vaccination)	Number of participants with solicited systemic AEs will be reported. Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 14 days post-vaccination (day of vaccination and the subsequent 14 days). Solicited systemic AEs are fatigue, headache, nausea, and myalgia.	Up to Day 15 (until 14 days post-vaccination)
Number of Participants with Unsolicited AEs Time Frame: Up to Day 30 (until 29 days post-vaccination)	Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.	Up to Day 30 (until 29 days post-vaccination)
Number of Participants with First UTI Event caused by E.coli Time Frame: Up to 3 years	Number of participants with first UTI event caused by E.coli will be reported.	Up to 3 years
Number of Participants with First IED Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by ExPEC9V O-serotypes Time Frame: Up to 4 years	Number of participants with first IED event, with microbiological confirmation in blood, other sterile sites, or urine, caused by ExPEC9V O-serotypes will be reported.	Up to 4 years
Number of All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes Time Frame: Up to 4 years	Number of all IEDs (including multiple IEDs per participant) caused by ExPEC9V O-serotypes will be reported.	Up to 4 years
Number of Participants with First Hospitalized IED Event Caused by ExPEC9V O-serotypes Time Frame: Up to 4 years	Number of participants with first hospitalized IED event caused by ExPEC9V O-serotypes will be reported.	Up to 4 years
Number of Participants with First IED Event Meeting Criteria for Sepsis Caused by ExPEC9V O-serotypes Time Frame: Up to 4 years	Number of participants with first IED event meeting criteria for sepsis caused by ExPEC9V O-serotypes will be reported.	Up to 4 years
Number of Participants with First Bacteremic IED Event Caused by ExPEC9V O-serotypes Time Frame: Up to 4 years	Number of participants with first bacteremic IED event caused by ExPEC9V O-serotypes will be reported.	Up to 4 years
Number of Participants with First Pyelonephritis Event Caused by ExPEC9V O-serotypes Time Frame: Up to 4 years	Number of participants with first pyelonephritis event caused by ExPEC9V O-serotypes will be reported.	Up to 4 years
Number of All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes Time Frame: Up to 3 years	Number of all UTIs (including multiple UTIs per participant) caused by ExPEC9V O-serotypes will be reported.	Up to 3 years
Number of Participants with First IED Event Caused by Escherichia coli (E.coli) Time Frame: Up to 4 years	Number of participants with first IED event caused by E.coli will be reported.	Up to 4 years
Number of Participants with First Pyelonephritis Event caused By E.coli Time Frame: Up to 4 years	Number of participants with first pyelonephritis event caused by E.coli will be reported.	Up to 4 years
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay Time Frame: Up to 4 years	Antibody titers to vaccine O-serotype antigens as determined by multiplex ECL-based immunoassay will be reported.	Up to 4 years
Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay Time Frame: Up to 4 years	Antibody titers to EPA as determined by multiplex ECL-based immunoassay will be reported.	Up to 4 years
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA) Time Frame: Up to 4 years	Antibody titers to vaccine O-serotype antigens as determined by MOPA will be reported.	Up to 4 years
Number of Participants with Serious Adverse Events (SAEs) Time Frame: Up to 181 days	A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.	Up to 181 days
Number of Participants with SAEs Related to Study Vaccine or Study Procedures Time Frame: Up to 4 years	A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. Participants with SAEs related to study procedures or vaccines will be reported in this outcome measure.	Up to 4 years
Short Form-36 (SF-36) Total Scores Time Frame: Up to 4 years	The SF-36 is a 36-item questionnaire with a recall period for all items of 1 week. The SF 36 version 2 includes 8 domains that measure physical functioning, role limitations due to physical health problems, bodily pain, general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and mental health (MH). The 8 domains can be aggregated into 2 summary scales that reflect physical and mental health: a physical component summary (PCS) and a mental component summary (MCS). Responses to all items are rated on a 3-, 5- or 6-point Likert scale. The scores range from 0 (lowest or worst possible level of functioning) to 100 (highest or best possible level of functioning).	Up to 4 years
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores Time Frame: Up to 4 years	The EQ-5D-5L is a standardized measure of health status. It is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Up to 4 years
Change from Baseline in Frailty Index Time Frame: Baseline to 4 years	Frailty will be assessed at baseline based on Short Physical Performance Battery (SPPB) score and will be calculated using participants self-reported information regarding health status (components of SF-36 and EQ-5D), and baseline health conditions collected through medical conditions of interest. The specific medical conditions of interest used for the calculation of the frailty index score will include: diabetes mellitus, history of myocardial infarction, congestive heart failure, hypertension, history of cerebrovascular disease (sequelae of stroke), chronic obstructive pulmonary disease (COPD), cancer, osteoarthritis or rheumatoid arthritis, gastric or duodenal ulcer, long term disability or handicap, hearing problems, migraine, cataract, and glaucoma. Total Frailty Index, ranging from 0 (not frail or best possible score) to 43 (frail or worst possible score), will be calculated as accumulation of individual's deficits.	Baseline to 4 years
Medical Resource Utilization (MRU) for IED Events Caused by ExPEC9V O-Serotype Time Frame: Up to Day 366 Post-IED	MRU for IED events caused by ExPEC9V O-serotype will be reported.	Up to Day 366 Post-IED
MRU for UTI Events Caused by ExPEC9V O-Serotype Time Frame: Up to Day 29 Post-UTI	MRU for UTI events caused by ExPEC9V O-serotype (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported.	Up to Day 29 Post-UTI
MRU for Acute Bacterial Prostatitis (ABP) Events Caused by ExPEC9V O-Serotype Time Frame: Up to Day 29 Post-ABP	Medical resource utilization for ABP events caused by ExPEC9V O-serotype (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported.	Up to Day 29 Post-ABP
Number of Participants with the Hospitalization for IED or, UTI, or ABP Events Caused by ExPEC9V O-Serotype Time Frame: Up to 4 years	Number of participants with hospitalization for IED or, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.	Up to 4 years
Length of Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype Time Frame: Up to 4 years	Length of stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.	Up to 4 years
Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events Caused by ExPEC9V O-Serotype Time Frame: Up to 3 months post clinical event	Number of participants with ICU hospitalization for IED or UTI or ABP events caused by ExPEC9V O-serotype will be reported.	Up to 3 months post clinical event
Length of ICU Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype Time Frame: Up to 3 months post clinical event	Length of ICU stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.	Up to 3 months post clinical event
Number of Participants with IED-related and All-cause Mortality Time Frame: Up to 4 years	Number of participants with IED-related and all-cause mortality will be reported.	Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Estimated)

May 19, 2025

Study Completion (Estimated)

June 29, 2029

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Estimated)

January 10, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CR109000
2020-005273-27 (EudraCT Number)
VAC52416BAC3001 (Other Identifier: Janssen Research & Development, LLC)
2023-506589-30 (Registry Identifier: EUCT Number)
2023-506589-30-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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Clinical Trials on Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Janssen Research & Development, LLC

Completed

A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older (Engage)

Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

United States, Belgium, Canada, Poland
Janssen Research & Development, LLC

Active, not recruiting

A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

Extraintestinal Pathogenic Escherichia Coli Prevention

United States, France, Belgium, Spain, Netherlands

Clinical Trials on ExPEC9V

Janssen Research & Development, LLC

Completed

A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older (Engage)

Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

United States, Belgium, Canada, Poland

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Clinical Trials on ExPEC9V

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations