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

Recruitment Status: COMPLETED
(See Contacts and Locations)Verified November 2025 by Janssen Research & Development, LLC
Sponsor: Janssen Research & Development, LLC
Information Provided by (Responsible Party): Janssen Research & Development, LLC

Clinicaltrials.gov Identifier: NCT04899336
Other Study ID Numbers:: CR109000

First Submitted: May 20, 2021
First Posted: May 23, 2021
Last Update Posted: December 4, 2025
Last Verified: November 2025

ClinicalTrials.gov processed this data on December 2025. Link to the current ClinicalTrials.gov record .

Study Details

Study 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.

Condition or Disease	Intervention/Treatment
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention	Biological: ExPEC9VOther: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	17935 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Prevention
Official Title	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
Study Start Date	June 29, 2021
Actual Primary Completion Date	August 26, 2025
Actual Study Completion Date	August 26, 2025

Groups and Cohorts

Group/Cohort	Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Number of Participants with First IED Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by ExPEC9V O-serotypes
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.
Number of All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes
Number of all IEDs (including multiple IEDs per participant) caused by ExPEC9V O-serotypes will be reported.
Number of Participants with First Hospitalized IED Event Caused by ExPEC9V O-serotypes
Number of participants with first hospitalized IED event caused by ExPEC9V O-serotypes will be reported.
Number of Participants with First IED Event Meeting Criteria for Sepsis Caused by ExPEC9V O-serotypes
Number of participants with first IED event meeting criteria for sepsis caused by ExPEC9V O-serotypes will be reported.
Number of Participants with First Bacteremic IED Event Caused by ExPEC9V O-serotypes
Number of participants with first bacteremic IED event caused by ExPEC9V O-serotypes will be reported.
Number of Participants with First Pyelonephritis Event Caused by ExPEC9V O-serotypes
Number of participants with first pyelonephritis event caused by ExPEC9V O-serotypes will be reported.
Number of Participants with First Urinary Tract Infection (UTI) Event Caused by ExPEC9V O-serotypes
Number of participants with first UTI event caused by ExPEC9V O-serotypes will be reported.
Number of All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes
Number of all UTIs (including multiple UTIs per participant) caused by ExPEC9V O-serotypes will be reported.
Number of Participants with First IED Event Caused by Escherichia coli (E.coli)
Number of participants with first IED event caused by E.coli will be reported.
Number of Participants with First Pyelonephritis Event caused By E.coli
Number of participants with first pyelonephritis event caused by E.coli will be reported.
Number of Participants with First UTI Event caused by E.coli
Number of participants with first UTI event caused by E.coli will be reported.
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay
Antibody titers to vaccine O-serotype antigens as determined by multiplex ECL-based immunoassay will be reported.
Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay
Antibody titers to EPA as determined by multiplex ECL-based immunoassay will be reported.
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA)
Antibody titers to vaccine O-serotype antigens as determined by MOPA will be reported.
Number of Participants with Solicited Local Adverse Events (AEs)
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).
Number of Participants with Solicited Systemic AEs
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.
Number of Participants with Unsolicited AEs
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.
Number of Participants with Serious Adverse Events (SAEs)
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.
Number of Participants with SAEs Related to Study Vaccine or Study Procedures
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.
Short Form-36 (SF-36) Total Scores
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).
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
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).
Change from Baseline in Frailty Index
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.
Medical Resource Utilization (MRU) for IED Events Caused by ExPEC9V O-Serotype
MRU for IED events caused by ExPEC9V O-serotype will be reported.
MRU for UTI Events Caused by ExPEC9V O-Serotype
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.
MRU for Acute Bacterial Prostatitis (ABP) Events Caused by ExPEC9V O-Serotype
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.
Number of Participants with the Hospitalization for IED or, UTI, or ABP Events Caused by ExPEC9V O-Serotype
Number of participants with hospitalization for IED or, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.
Length of Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype
Length of stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.
Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events Caused by ExPEC9V O-Serotype
Number of participants with ICU hospitalization for IED or UTI or ABP events caused by ExPEC9V O-serotype will be reported.
Length of ICU Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype
Length of ICU stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.
Number of Participants with IED-related and All-cause Mortality
Number of participants with IED-related and all-cause mortality will be reported.

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
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

Contacts and Locations

Sponsors and Collaborators	Janssen Research & Development, LLC
Locations	Lakeview Clinical Research \| Guntersville Alabama, United States, 35976Hope Research Institute \| Phoenix Arizona, United States, 85018Hope Research Institute \| Phoenix Arizona, United States, 85108Interspond-Clinical Research Institute of AZ \| Sun City West Arizona, United States, 85357Baptist Health Center For Clinical Research \| Little Rock Arkansas, United States, 72205Sun Urology - Buena Park Office \| Buena Park California, United States, 90621Hope clinical Research LLC \| Canoga Park California, United States, 91303Velocity Clinical Research, Inc. \| Chula Vista California, United States, 91911Marvel Clinical Research \| Huntington Beach California, United States, 92647California Adult Circumcision - Alvarado La Mesa Urology Center \| La Mesa California, United States, 91942Om Research LLC \| Lancaster California, United States, 93534Atlantic Urology Medical Group \| Long Beach California, United States, 90806-2766Long Beach Clinical Trials, LLC \| Long Beach California, United States, 90806American Institute of Research \| Los Angeles California, United States, 90017Kaiser Permanente Los Angeles Medical Center \| Los Angeles California, United States, 90027Southern California Permanente Medical Group \| Los Angeles California, United States, 90027Comprehensive Urology \| Los Angeles California, United States, 90048Veterans Affairs Greater Los Angeles HCS \| Los Angeles California, United States, 90073VA Sacramento Medical Center \| Mather California, United States, 95655Hoag Medical Group \| Newport Beach California, United States, 92663Kaiser Permanente Vaccine Study Center \| Oakland California, United States, 94612Empire Clinical Research, LLC \| Pomona California, United States, 91767Inland Urology Medical Group \| Pomona California, United States, 91767UC Davis Health System \| Sacramento California, United States, 92647Northern California Research \| Sacramento California, United States, 95821San Diego Sports Medicine & Family Health Center \| San Diego California, United States, 92120Medical Associates Research Group, Inc. \| San Diego California, United States, 92123California Kidney Specialists \| San Dimas California, United States, 91773Prestige Medical Group \| Santa Ana California, United States, 92705Millennium Clinical Trials LLC \| Simi Valley California, United States, 93065San Antonio Regional Hospital \| Upland California, United States, 91786Yale University \| New Haven Connecticut, United States, 06510Ideal Clinical Research \| Adventura Florida, United States, 33180Bay Pines VA Healthcare System \| Bay Pines Florida, United States, 33744Nova Clinical Research, LLC \| Bradenton Florida, United States, 34209Clinical Research of Brandon \| Brandon Florida, United States, 33511Moore Clinical Reseach - Brandon Clinic \| Brandon Florida, United States, 33511Florida Medical Center of Clearwater \| Clearwater Florida, United States, 33755Innovative Research of West Florida, Incorporated \| Clearwater Florida, United States, 33756Advanced Clinical Research Network \| Coral Gables Florida, United States, 33134Prestige Clinical Research Center, Inc. \| Coral Gables Florida, United States, 33134Accel Research Sites \| DeLand Florida, United States, 32720Doral Medical Research \| Doral Florida, United States, 33166Universal Axon Clinical Research \| Doral Florida, United States, 33166Florida Medical Research Institute \| Gainesville Florida, United States, 32607Indago Research & Health Center Inc \| Hialeah Florida, United States, 33012Prestige Clinical Research \| Homestead Florida, United States, 33030Multi Specialty Research Associates Inc \| Lake City Florida, United States, 32055ClinCloud Clinical Research \| Maitland Florida, United States, 32751Nova Clinical Research Center \| Miami Florida, United States, 33124Finlay Medical Research \| Miami Florida, United States, 33126Royal Care Medical Research Corporation \| Miami Florida, United States, 33133Retreat Medical Research LLC \| Miami Florida, United States, 33135Suncoast Research Group \| Miami Florida, United States, 33135Continental Research \| Miami Florida, United States, 33144-4273Dynamic Medical Research, LLC \| Miami Florida, United States, 33144Florida International Medical Research \| Miami Florida, United States, 33155Health- Life Research Inst \| Miami Florida, United States, 33155Office of Dr. Marisela Gonzalez \| Miami Florida, United States, 33155Felicidad Medical Research \| Miami Florida, United States, 33185A and R Research Group \| Miami Florida, United States, 33186Alpha Science Research \| Miami Florida, United States, 33186Clinical NeuroScience Solutions Inc \| Orlando Florida, United States, 32801Omega Research Consultants \| Orlando Florida, United States, 32808Pines Care Research Center Inc \| Pembroke Pines Florida, United States, 33024Clinical Research of Central Florida \| Plant City Florida, United States, 33563Care Access Research \| Spring Hill Florida, United States, 34609Tampa General Hospital \| Tampa Florida, United States, 33603Theia Clincial Research, LLC \| Tampa Florida, United States, 33613Precision Research Institute \| Tampa Florida, United States, 33614St. Joseph's Comprehensive Research Institute \| Tampa Florida, United States, 33614Santos Research Center \| Tampa Florida, United States, 33615Care Access Research \| Tampa Florida, United States, 33625Agile Clinical Research Trials, LLC \| Atlanta Georgia, United States, 30328Columbus Regional Research Institute \| Columbus Georgia, United States, 31904Atlanta VA Medical Center \| Decatur Georgia, United States, 30033Clinical Research Prime \| Idaho Falls Idaho, United States, 83404Snake River Research, PLLC \| Idaho Falls Idaho, United States, 83404Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion \| Chicago Illinois, United States, 60611Jesse Brown VAMC Department of Surgery \| Chicago Illinois, United States, 60612University Of Illinois \| Chicago Illinois, United States, 60612Medisphere Medical Research Center, Llc \| Evansville Indiana, United States, 47714Asha Clinical Research-Munster Llc \| Hammond Indiana, United States, 46324Mishawaka Osteopathic Clinic/MOC Research \| Mishawaka Indiana, United States, 46544Cypress Medical Research Center \| Wichita Kansas, United States, 67226Tandem Clinical Research \| Marrero Louisiana, United States, 70072KAMP Medical Research, Inc \| Natchitoches Louisiana, United States, 71457Ochsner Medical Center \| New Orleans Louisiana, United States, 70121Kaiser Permanente \| Rockville Maryland, United States, 20852Floating Hospital For Children at Tufts Medical Center \| Boston Massachusetts, United States, 02111West Roxbury Veterans Affairs Medical Center \| West Roxbury Massachusetts, United States, 02132-4927Henry Ford Hospital \| Detroit Michigan, United States, 48202William Beaumont Hospital \| Royal Oak Michigan, United States, 48073MediSync Clinical Research \| Petal Mississippi, United States, 39465Meridian Clinical Research, LLC \| Grand Island Nebraska, United States, 68803Be Well Clinical Studies \| Lincoln Nebraska, United States, 68516Meridian Clinical Research, LLC \| Norfolk Nebraska, United States, 68701Hope Research Institute \| Las Vegas Nevada, United States, 89106Sierra Clinical Research \| Las Vegas Nevada, United States, 89106Excel Clinical Research \| Las Vegas Nevada, United States, 89109VA Sierra Nevada Health Care System \| Reno Nevada, United States, 89509I.D. Care, Inc. \| Hillsborough New Jersey, United States, 08844Holy Name Medical Center \| Teaneck New Jersey, United States, 07666Meridian Clinical Research, LLC \| Binghamton New York, United States, 13901Meridian Clinical Research, LLC \| Endwell New York, United States, 13760Manhattan Medical Research \| New York New York, United States, 10016Montefiore Medical Center \| The Bronx New York, United States, 10467Durham VAMC \| Durham North Carolina, United States, 27705Carolina Institute for Clinical Research \| Fayetteville North Carolina, United States, 28303ECU Health Vidant Medical Center \| Greenville North Carolina, United States, 27834Plains Clinical Research \| Fargo North Dakota, United States, 58104Kroger Health \| Centerville Ohio, United States, 45458University Hospitals Cleveland Medical Center \| Cleveland Ohio, United States, 44106Remington Davis Inc \| Columbus Ohio, United States, 43215Kroger Health \| Englewood Ohio, United States, 45322The Little Clinic \| Englewood Ohio, United States, 45322Comprehensive Internal Medicine \| Wooster Ohio, United States, 44691Tekton Research Inc. \| Yukon Oklahoma, United States, 73099Kaiser Permanente \| Portland Oregon, United States, 97227Capital Area Research \| Camp Hill Pennsylvania, United States, 17011Reading Hospital \| West Reading Pennsylvania, United States, 19611Hugh D. Durrence, MD, PC \| Charleston South Carolina, United States, 29412Waterway Familiy Medicine \| Little River South Carolina, United States, 29566Novel Research LLC \| Bellaire Texas, United States, 77401Global Medical Research - Dallas \| Dallas Texas, United States, 75224Medical City Dallas \| Dallas Texas, United States, 75230North Texas Infectious Diseases Consultants \| Dallas Texas, United States, 75246Digestive Health Associates \| Houston Texas, United States, 77024EPIC Clinical Research \| Lewisville Texas, United States, 75057SMS Clinical Research LLC \| Mesquite Texas, United States, 75149Be Well Clinical Studies \| Round Rock Texas, United States, 78681Audie L Murphy Memorial Va Ho \| San Antonio Texas, United States, 78229Sherman Clinical Research \| Sherman Texas, United States, 75092Lone Peak Family Medicine \| Draper Utah, United States, 84020Clinical Alliance for Research and Education \| Annandale Virginia, United States, 22003-7347Charlottesville Medical Research Center, LLC \| Charlottesville Virginia, United States, 22911Infectious Disease Associates of Central Virginia \| Lynchburg Virginia, United States, 24501IACT - Suffolk Multispecialty Research \| Suffolk Virginia, United States, 23435Selma Medical Associates \| Winchester Virginia, United States, 22601Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney \| Cheney Washington, United States, 99004Exemplar Research, Inc \| Morgantown West Virginia, United States, 26505Marshfield Clinic \| Marshfield Wisconsin, United States, 54449Saint Andrew's War Memorial Hospital \| Brisbane , Australia, 4001GP Surgery - Campbelltown \| Campbelltown , Australia, 5074Barwon Health - University Hospital Geelong \| Geelong , Australia, 3220CMAX Clinical Research \| Melbourne , Australia, 5000John Hunter Hospital \| New Lambton , Australia, 2305Fiona Stanley Hospital \| Palmyra DC , Australia, 6961McIntyre Medical Center \| Para Hills West , Australia, 5096North West Medical Center \| Salisbury , Australia, 5108Mater Medical Centre South Brisbane \| South Brisbane , Australia, 4101Bene Aged Care - Italian Village \| St Agnes , Australia, 5097Westmead Hospital \| Sydney , Australia, 2145AusTrials Pty Ltd \| Taringa , Australia, 4068AusTrials Pty Ltd \| Tarragindi , Australia, 4121Adelaide Medical Solutions \| Woodville , Australia, 5011CARe Clinical Ltd \| Calgary Alberta, Canada, T4P 1K4University of Alberta \| Edmonton Alberta, Canada, T6G121CARe Clinical Ltd \| Red Deer Alberta, Canada, T4P 1K4Vancouver ID Research and Care Centre Society \| Vancouver British Columbia, Canada, V6Z2C7Health Sciences North \| Greater Sudbury Ontario, Canada, P3E 5J1Dawson Road Family Health Team \| Guelph Ontario, Canada, N1H 1B1Bluewater Clinical Research Group Inc. \| Sarnia Ontario, Canada, N7T 4X3Winchester District Memorial Hospital \| Winchester Ontario, Canada, K0C2K0Alpha Recherche Clinique \| Québec Quebec, Canada, G2J 0C4Alpha Recherche Clinique \| Québec Quebec, Canada, G3K 2P8West China School of Medicine/West China Hospital, Sichuan University \| Chengdu , China, 610041Funan Center for Disease Control and Prevention \| Fuyang , China, 236399The First Affiliated Hospital of Guangzhou Medical University \| Guangzhou , China, 510120The Second Affiliated Hospital of Guangzhou Medical University \| Guangzhou , China, 5102601st Affiliated Hospital of Zhejiang University Medical College \| Hangzhou , China, 310003Anhui Provincial Center for Disease Control and Prevention \| Hefei , China, 230601Huoqiu County Center For Disease Control and Prevention \| Liuan , China, 237400Jiangsu Provincial Center for Disease Control and Prevention \| Nanjing , China, 210009Nanjing Medical University \| Nanjing , China, 211112Huashan Hospital affiliated to Fudan University \| Shanghai , China, 200040Suzhou Municipal Hospital \| Suzhou , China, 215002Taizhou Peoples Hospital \| Taizhou , China, 225300Yixing People's Hospital \| Wuxi , China, 214200Clinica de la Costa \| Barranquilla , Colombia, 080001IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S. \| Barranquilla , Colombia, 80020Centro de Investigaciones y Proyectos en Neurociencias CIPNA \| Barranquilla , Colombia, Centro de Atencion e Investigacion Medica S.A. - CAIMED \| Casanare , Colombia, 856010Fundacion Cardiovascular de Colombia \| Floridablanca , Colombia, Centro de Atencion e Investigacion Medica S.A. - CAIMED \| Girardot , Colombia, 252432Centro de Atencion e Investigacion Medica S.A. - CAIMED \| Helechos , Colombia, Asociacion IPS Medicos Internistas de Caldas \| Manizales , Colombia, 170001CAIMED Acacias \| Meta , Colombia, 507001Fundacion Centro de Investigaciones Clinicas IPS Cardiomet \| Pereira , Colombia, 660003Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc \| Villavicencio , Colombia, 500001Uromeda \| Brno , Czechia, 61500Ordinace Hradebni s.r.o. \| České Budějovice , Czechia, 37001Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi \| Dolní Břežany , Czechia, 252 41Centrum Ockovani a Cestovi Mediciny \| Hradec Králové , Czechia, 50002Res Medica \| Nový Knín , Czechia, 262 03PreventaMed, s.r.o. \| Olomouc , Czechia, 77900GYNURO s.r.o \| Ostrava-Proskovice , Czechia, 72400Ambulance name: Gynekologická ordinace MUDr \| Pilsen , Czechia, 30100MUDr. Mita Rosenberg \| Pilsen , Czechia, 323 00Gona s.R.o- Orfinace Harov \| Prague , Czechia, 13000Zdravi-fit, s.r.o. \| Protivín , Czechia, 39811Nemocnice Slany \| Slaný , Czechia, 274 01Progerint s.r.o. \| Vysoké Mýto , Czechia, 56601Aalborg Universitetshospital Nord \| Hellerup , Denmark, 2900Gentofte Hospital \| Herlev , Denmark, 2730Nordsjaellands Hospital - Hillerod \| Hilleroed , Denmark, 3400Hvidovre Hospital \| Hvidovre , Denmark, 2650Odense Universitetshospital \| Odense M , Denmark, 5230Sjællands University hospital \| Roskilde , Denmark, 4000Centre Hospitalier Annecy Genevois \| Annecy , France, 74370CHU Dijon Bourgogne - Hopital Francois Mitterrand \| Dijon , France, 21000CHU de Limoges \| Limousis , France, 87042Hopital de La Croix Rousse \| Lyon , France, 69004CHU Nimes Hopital Caremeau \| Nîmes , France, 30029Centre hospitalier Lyon-Sud \| Pierre-Bénite , France, 69495CHU Saint Etienne Hopital Nord \| Saint-Priest-en-Jarez , France, 42270Universitatsklinikum Frankfurt \| Frankfurt , Germany, 60590Universitatsklinikum Jena \| Jena , Germany, 07747Familienmedizinisches Zentrum Radowsky \| Leipzig , Germany, 04179SIBAmed GmbH & Co. KG \| Leipzig , Germany, 4103Universitaetsklinikum Giessen und Marburg GmbH \| Marburg , Germany, 35037Red-Institut für medizinische Forschung und Fortbildung \| Oldenburg in Holstein , Germany, 23758Praxis Dr. Weimer \| Reinfeld , Germany, 23858Universitaetsmedizin Rostock \| Rostock , Germany, 18057KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC) \| Belagavi , India, 590010S. R. Kalla Memorial General Hospital \| Jaipur , India, 302006Nil Ratan Sircar Medical College and Hospital \| Kolkata , India, 700014Regency health super specialty hospital \| Lucknow , India, 226022Asian Institute Of Medical Science \| Mumbai , India, 421203Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research \| Mysuru , India, 570015Indraprastha Apollo Hospital \| New Delhi , India, 1100776Shree Giriraj Multispeciality Hospital \| Rajkot , India, 360004Nirmal Hospital Pvt. Ltd. \| Surat , India, 395002BAPS Pramukhswami Hospital \| Surat , India, 395009Samson Assuta Ashdod University Hospital \| Ashdod , Israel, 7747629Hadassah Medical Center \| Jerusalem , Israel, 9112001Meir Medical Center \| Kfar Saba , Israel, 44281The Chaim Sheba Medical Center \| Ramat Gan , Israel, 52621Tel Aviv Sourasky Medical Center \| Tel Aviv , Israel, 6423906ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti \| Chieti , Italy, 66100Istituto Nazionale Tumori Regina Elena \| Roma , Italy, 00144Azienda Ospedaliera Sant Andrea \| Rome , Italy, 00189Akashi Medical Center \| Akashi Shi , Japan, 674 0063Fukuoka Shinmizumaki Hospital \| Fukuoka , Japan, 807-0051Fukuoka Wajiro Hospital \| Fukuoka , Japan, 811-0213Hakodate Goryoukaku Hospital \| Hakodate , Japan, 040 8611Matsunami General Hospital \| Hashima-gun , Japan, 5016062Teine Keijinkai Hospital \| Hokkaido , Japan, 006-8555Aso Co.,Ltd Iizuka Hospital \| Iizuka , Japan, 820-8501Inoue Hospital \| Itoshima , Japan, 8191104Kano Hospital \| Kasuya-gun , Japan, 811-3112Kanto Rosai Hospital \| Kawasaki , Japan, 211-8510Shinkomonji hospital \| Kitakyushu , Japan, 800-0057Japan Community Health care Organization Kyushu Hospital \| Kitakyushu , Japan, 8000295JRC Nagasaki Genbaku Hospital \| Nagasaki , Japan, 852-8511Kyoujinkai Clinic Komatsu \| Neyagawa , Japan, 572-8567Omuta City Hospital \| Omuta-Shi , Japan, 836-0861Kyobashi Sugimoto Clinic \| Osaka , Japan, 5340024Japan Community Health Care Organization Osaka Hospital \| Osaka , Japan, 5530003Abe Diabetes Clinic \| Ōita , Japan, 8700039Almeida Memorial Hospital \| Ōita , Japan, 8701195National Hospital Organization Nagasaki Medical Center \| Ōmura , Japan, 856-8562National Hospital Organization Shikoku Cancer Center \| Sanuki , Japan, 7692393Teine Maeda Urology Clinic \| Sapporo , Japan, 006-0812Teine Urological Clinic \| Sapporo , Japan, 0060816Nanbu Tokushukai Hospital \| Shimajiri-Gun , Japan, 9010493Shimonoseki City Hospital \| Shimonoseki-shi , Japan, 7500061Tokyo Shinagawa Hospital \| Shinagawa City , Japan, 1408522Suita Tokushukai Hospital \| Suita-Shi , Japan, 5650814Japanese Red Cross Society Suwa Hospital \| Suwa-Shi , Japan, 3928510Japan Community Health care Organization Kyushu Hospital \| Yahatanishi-ku , Japan, 806-8501Shimonoseki City Hospital \| Yamaguchi , Japan, 750-0041Yokohama Rosai Hospital \| Yokohama , Japan, 222-0036National Hospital Organization Yokohama Medical Center \| Yokohama , Japan, 245-8575Leiden University Medical Center \| Leiden , Netherlands, 2333 ZAZiekenhuis \| Uden , Netherlands, 5406 PTThe Julius Center - Utrecht Science Park - Stratenum \| Utrecht , Netherlands, 3508 GASouthern Clinical Trials Totara Clinical Research \| Auckland , New Zealand, 0600Southern Clinical Trials Ltd \| Auckland , New Zealand, 0626Optimal Clinical Trials \| Auckland , New Zealand, 1011Tauranga Urology Research Limited \| Bay of Plenty , New Zealand, 3112Canterbury Urology Research Trust \| Christchurch , New Zealand, 8013Southern Clinical Trials Ltd \| Christchurch Central , New Zealand, 8013P3 Research Ltd \| Dunedin , New Zealand, 9016Lakeland Clinical Trials \| Hamilton , New Zealand, 3200P3 Research Ltd \| Hastings , New Zealand, 4122P3 Research - Lower Hutt \| Lower Hutt , New Zealand, 5010Southern Clinical Trials Ltd \| Nelson , New Zealand, 7011P3 Research Ltd \| Palmerston North , New Zealand, 4414Culloden Research Ltd \| Papamoa , New Zealand, 3118Middlemore Clinical Trials \| Papatoetoe , New Zealand, 2025Optimal Clinical Trials \| Rosedale , New Zealand, 632Lakeland Clinical Trials \| Rotorua , New Zealand, 3010P3 Research Ltd \| Tauranga , New Zealand, 3110Lakeland Clinical Trials \| Upper Hutt , New Zealand, 5018P3 Research Limited Kapiti \| Wellington , New Zealand, 5032Capatial & Coast District Health Board \| Wellington , New Zealand, 6242Dong-A University Hospital \| Busan , South Korea, 602 812Hallym University Chuncehon Medical Center \| Chuncheon , South Korea, 24253Chungnam National University Hospital \| Daejeon , South Korea, 35015Chunnam National University Hospital \| Gwangju , South Korea, 501-757Korea University Ansan Hospital \| Gyeonggi-do , South Korea, 15355Inha University Hospital \| Incheon , South Korea, 22322Seoul National University Bundang Hospital \| Seongnam-si , South Korea, 13620Kangbuk Samsung Hospital \| Seoul , South Korea, 03181Asan Medical Center \| Seoul , South Korea, 05505Samsung Medical Center \| Seoul , South Korea, 06351Hallym University Sacred Heart Hospital \| Seoul , South Korea, 07441Ewha Womans University Mokdong Hospital \| Seoul , South Korea, 07985Korea University Guro Hospital \| Seoul , South Korea, 8308The Catholic university of Korea, St. Vincent's Hospital \| Suwon , South Korea, 16247WonJu Severance Christian Hospital \| Wŏnju , South Korea, 220-701Hosp. Gral. Univ. Dr. Balmis \| Alicante , Spain, 3010Hosp Clinic de Barcelona \| Barcelona , Spain, 08036Hosp. Univ. de Bellvitge \| Barcelona , Spain, 08907Hosp. Del Mar \| Barcelona , Spain, 8003Consorci D'Atenció Primària de Salut Barcelona Esquerra \| Barcelona , Spain, 8028Hosp Reina Sofia \| Córdoba , Spain, 14004Hosp. Univ. Dr. Josep Trueta \| Girona , Spain, 17007Hosp. de Jerez de La Frontera \| Jerez de la Frontera , Spain, 11407CAP Dr. Vicenç Papaceit ABS LA ROCA \| La Roca del Vallès , Spain, 8430Hosp. Univ. de La Princesa \| Madrid , Spain, 28006Hosp. Univ. La Paz \| Madrid , Spain, 28046Hospital Sanitas La Moraleja \| Madrid , Spain, 28050Hosp. Univ. Hm Monteprincipe \| Madrid , Spain, 28660Hosp. Quirónsalud Málaga \| Málaga , Spain, 29004Complexo Hosp. Univ. de Ourense \| Ourense , Spain, 32005Hosp. Univ. Son Espases \| Palma de Mallorca , Spain, 07120Corporacio Sanitari Parc Tauli \| Sabadell , Spain, 08208Hosp. Virgen Macarena \| Seville , Spain, 41009Hosp. Alvaro Cunqueiro \| Vigo , Spain, 36312Helsingborgs lasarett \| Helsingborg , Sweden, 25187BTH Research & Development Clinic \| Karlskrona , Sweden, 37179CTC Ebbepark \| Linkoaping , Sweden, 582 13Skanes universitetssjukhus \| Malmö , Sweden, 21428CTC GoCo \| Mölndal , Sweden, 43153Universitetssjukhuset Orebro \| Örebro , Sweden, 70362ClinSmart Sweden AB \| Solna , Sweden, 171 64ClinSmart Sweden AB \| Uppsala , Sweden, 752 37Kaohsiung Veterans General Hospital \| Kaohsiung City , Taiwan, 813National Cheng Kung University Hospital \| Tainan , Taiwan, 704Chang Gung Memorial Hospital Linkou Branch \| Taoyuan , Taiwan, 333King Chulalongkorn Memorial Hospital \| Bangkok , Thailand, 10330Thai Red Cross Aids Research Centre \| Bangkok , Thailand, 10330Ramathibodi Hospital \| Bangkok , Thailand, 10400Tropical Medicine Hospital, Mahidol University \| Bangkok , Thailand, 10400Siriraj Hospital \| Bangkok , Thailand, 10700Aberdeen Royal Infirmary \| Aberdeen , United Kingdom, AB25 2ZNAtherstone Surgery \| Atherstone , United Kingdom, CV9 1EUBanbury Cross Health Center \| Banbury , United Kingdom, OX16 9ADFutureMeds Bridle Clinic \| Birkenhead , United Kingdom, CH62 6EEFutureMeds-Soho UK \| Birmingham , United Kingdom, B21 0RYBlackpool Teaching Hospitals NHS Foundation Trust \| Blackpool , United Kingdom, FY3 8NRRoyal Bournemouth Hospital \| Bournemouth , United Kingdom, BH7 7DWNorth Bristol NHS Trust \| Bristol , United Kingdom, BS10 5NBUniversity Hospitals Bristol NHS Trust \| Bristol , United Kingdom, BS2 8BJRoyal Devon & Exeter NHS Foundation Trust \| Exeter , United Kingdom, EX2 5DWEynsham Medical Centre \| Eynsham , United Kingdom, OX29 4QBThe Garth Surgery \| Guisborough , United Kingdom, TS14 7DJUniversity Hospitals Of Leicester Nhs Trust \| Leicester , United Kingdom, LE1 5WWKing's College Hospital NHS Foundation Trust \| London , United Kingdom, SE5 9RSManchester Royal Infirmary \| Manchester , United Kingdom, M13 9WLThe NIHR Manchester Clinical Research Facility \| Manchester , United Kingdom, M23 9LTSouth Tees Hospitals NHS Foundation Trust \| Middlesbrough , United Kingdom, TS4 3BWNottingham University Hospitals NHS Trust \| Nottingham , United Kingdom, NG7 2UHPlymouth University Hospitals Trust \| Plymouth , United Kingdom, PL6 8DHAshgrove Surgery \| Pontypridd , United Kingdom, CF37 2DRThe Adam Practice \| Poole , United Kingdom, BH15 4JQSheffield Teaching Hospitals NHS Foundation Trust \| Sheffield , United Kingdom, S10 2 JFMidlands Partnership NHS Foundation Trust \| Stafford , United Kingdom, ST16 3SRNorth Tees Furturemeds \| Stockton-on-Tees , United Kingdom, TS19 8PEMid Yorkshire Hospital NHS Trust- Pinderfields Hospital \| Wakefield , United Kingdom, WF1 4DGChurch Street Practice \| Wantage , United Kingdom, OX12 9BNWindrush Medical Practice \| Witney , United Kingdom, OX28 6JS
Investigators	Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

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Doiron RC, Cotechini T, Nickel JC. It's Time to Embrace Vaccination as We Enter the Postantibiotic Era of Recurrent Urinary Tract Infection Management. J Urol. 2024 Jun;211(6):797-799. doi: 10.1097/JU.0000000000003969. Epub 2024 May 5. No abstract available. Doua J, Ekkelenkamp M, Verheij T, Go O, Ruhmel S, Leathers K, Spiessens B, van Rooij S, Fowler VG Jr, Geurtsen J, Dolor R, Sarnecki M, Chatterjee R, Poolman J, Bonten M; on behalf COMBACTE-NET consortium/EXPECT study group. Feasibility of tracking invasive Escherichia coli disease among older adults in a community setting: A prospective observational study. Eur J Clin Microbiol Infect Dis. 2024 Mar;43(3):541-550. doi: 10.1007/s10096-023-04738-y. Epub 2024 Jan 18.