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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

Primary Purpose

Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ExPEC9V
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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, 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
  • Chronic systemic prophylactic use of antibacterials (including antibiotics and urinary tract antiseptics). Repeated courses administered for recurrent UTIs preceding randomization will not be referred to as 'chronic'. In case of chronic prophylactic use of antibacterials, the last dose must have been administered > 60 days prior to randomization
  • 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

Sites / Locations

  • Lakeview Clinical ResearchRecruiting
  • Hope Research InstituteRecruiting
  • Hope Research InstituteRecruiting
  • Interspond-Clinical Research Institute of AZRecruiting
  • Baptist Health Center for Clinical ResearchRecruiting
  • Hope clinical Research LLCRecruiting
  • Velocity Clinical Research, Inc.Recruiting
  • Marvel Clinical ResearchRecruiting
  • California Adult Circumcision - Alvarado La Mesa Urology CenterRecruiting
  • Om Research LLC
  • Long Beach Clinical Trials, LLCRecruiting
  • American Institute of ResearchRecruiting
  • Southern California Permanente Medical GroupRecruiting
  • Comprehensive UrologyRecruiting
  • Veterans Affairs Greater Los Angeles HCSRecruiting
  • VA Sacramento Medical CenterRecruiting
  • Empire Clinical Research, LLCRecruiting
  • UC Davis Health SystemRecruiting
  • Northern California ResearchRecruiting
  • San Diego Sports Medicine & Family Health CenterRecruiting
  • Medical Associates Research Group, Inc.Recruiting
  • California Kidney SpecialistsRecruiting
  • Millennium Clinical Trials, LLCRecruiting
  • San Antonio Regional HospitalRecruiting
  • Yale UniversityRecruiting
  • Ideal Clinical ResearchRecruiting
  • Bay Pines VA Healthcare SystemRecruiting
  • Nova Clinical Research, LLCRecruiting
  • Clinical Research of BrandonRecruiting
  • Moore Clinical Reseach - Brandon ClinicRecruiting
  • Florida Medical Center of ClearwaterRecruiting
  • Innovative Research of West Florida, IncorporatedRecruiting
  • Advanced Clinical Research NetworkRecruiting
  • Prestige Clinical Research Center, Inc.Recruiting
  • Accel Research SitesRecruiting
  • Doral Medical ResearchRecruiting
  • Universal Axon Clinical ResearchRecruiting
  • Florida Medical Research InstituteRecruiting
  • Indago Research & Health Center IncRecruiting
  • Prestige Clinical ResearchRecruiting
  • Multi-Specialty Research Associates, Inc.Recruiting
  • ClinCloud Clinical ResearchRecruiting
  • Nova Clinical Research CenterRecruiting
  • Finlay Medical ResearchRecruiting
  • Royal Care Medical Research CorporationRecruiting
  • Retreat Medical Research LLCRecruiting
  • Suncoast Research GroupRecruiting
  • Continental ResearchRecruiting
  • Dynamic Medical Research, LLCRecruiting
  • Florida International Medical ResearchRecruiting
  • Health- Life Research InstRecruiting
  • Office of Dr. Marisela GonzalezRecruiting
  • Felicidad Medical ResearchRecruiting
  • A&R Research GroupRecruiting
  • Alpha Science ResearchRecruiting
  • Clinical NeuroScience Solutions, IncRecruiting
  • Omega Research ConsultantsRecruiting
  • Pines Care Research Center IncRecruiting
  • Clinical Research of Central FloridaRecruiting
  • Care Access ResearchRecruiting
  • Tampa General HospitalRecruiting
  • Theia Clincial Research, LLC
  • Precision Research InstituteRecruiting
  • St. Joseph's Comprehensive Research Institute
  • Santos Research CenterRecruiting
  • Care Access ResearchRecruiting
  • Agile Clinical Research Trials, LLC
  • Columbus Regional Research InstituteRecruiting
  • Atlanta VA Medical CenterRecruiting
  • Clinical Research Prime
  • Snake River Research, PLLCRecruiting
  • Jesse Brown VAMC Department of SurgeryRecruiting
  • University Of IllinoisRecruiting
  • Medisphere Medical Research Center, LlcRecruiting
  • Asha Clinical Research-Munster LlcRecruiting
  • Mishawaka Osteopathic Clinic/MOC ResearchRecruiting
  • Cypress Medical Research Center
  • Tandem Clinical ResearchRecruiting
  • KAMP Medical Research, IncRecruiting
  • Ochsner Medical CenterRecruiting
  • Kaiser PermanenteRecruiting
  • West Roxbury Veterans Affairs Medical CenterRecruiting
  • Henry Ford HospitalRecruiting
  • William Beaumont HospitalRecruiting
  • MediSync Clinical Research
  • Meridian Clinical Research, LLCRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Hope Research Institute
  • Sierra Clinical ResearchRecruiting
  • Excel Clinical ResearchRecruiting
  • VA Sierra Nevada Health Care System
  • I.D. Care, Inc.Recruiting
  • Meridian Clinical Research, LLCRecruiting
  • Montefiore Medical CenterRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Durham VAMCRecruiting
  • Carolina Institute for Clinical ResearchRecruiting
  • Plains Clinical ResearchRecruiting
  • Kroger HealthRecruiting
  • Remington Davis IncRecruiting
  • Kroger HealthRecruiting
  • The Little ClinicRecruiting
  • Comprehensive Internal Medicine
  • Tekton Research Inc.Recruiting
  • Capital Area ResearchRecruiting
  • Reading HospitalRecruiting
  • Hugh D. Durrence, MD, PCRecruiting
  • Waterway Familiy MedicineRecruiting
  • Novel Research LLCRecruiting
  • Global Medical Research - DallasRecruiting
  • Medical City DallasRecruiting
  • North Texas Infectious Diseases ConsultantsRecruiting
  • Digestive Health AssociatesRecruiting
  • EPIC Clinical ResearchRecruiting
  • SMS Clinical Research LLCRecruiting
  • Be Well Clinical StudiesRecruiting
  • Audie L Murphy Memorial Va HoRecruiting
  • Sherman Clinical ResearchRecruiting
  • Lone Peak Family Medicine
  • Clinical Alliance for Research and EducationRecruiting
  • Charlottesville Medical Research Center, LLCRecruiting
  • Infectious Disease Associates of Central VirginiaRecruiting
  • IACT - Suffolk Multispecialty ResearchRecruiting
  • Selma Medical AssociatesRecruiting
  • Multicare Institute For Research & Innovation - Rockwood Clinic - CheneyRecruiting
  • Exemplar Research, IncRecruiting
  • Marshfield ClinicRecruiting
  • Saint Andrew's War Memorial HospitalRecruiting
  • GP Surgery - Campbelltown
  • Barwon Health - University Hospital GeelongRecruiting
  • CMAX Clinical Research
  • John Hunter HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • McIntyre Medical Center
  • North West Medical Center
  • Mater Medical Centre - South Brisbane
  • Bene Aged Care - Italian Village
  • Westmead HospitalRecruiting
  • AusTrials Pty Ltd
  • AusTrials Pty Ltd
  • Adelaide Medical Solutions
  • University of Alberta
  • CARe Clinical LtdRecruiting
  • Vancouver ID Research and Care Centre SocietyRecruiting
  • Dawson Road Family Health TeamRecruiting
  • Bluewater Clinical Research Group Inc.Recruiting
  • Health Sciences NorthRecruiting
  • Winchester District Memorial HospitalRecruiting
  • Alpha Recherche CliniqueRecruiting
  • Alpha Recherche CliniqueRecruiting
  • West China School of Medicine/West China Hospital, Sichuan UniversityRecruiting
  • Funan Center for Disease Control and PreventionRecruiting
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Anhui Provincial Center for Disease Control and PreventionRecruiting
  • Nanjing Medical UniversityRecruiting
  • Suzhou Municipal HospitalRecruiting
  • UromedaRecruiting
  • Ordinace Hradebni s.r.o.Recruiting
  • Aesculap Ambulance sro - Zdravotni Stredisko Centrum ZdraviRecruiting
  • Centrum Ockovani a Cestovi MedicinyRecruiting
  • Res MedicaRecruiting
  • PreventaMed, s.r.o.Recruiting
  • GYNURO s.r.oRecruiting
  • MUDr. Mita RosenbergRecruiting
  • Ambulance name: Gynekologická ordinace MUDrRecruiting
  • Zdravi-fit, s.r.o.Recruiting
  • Nemocnice SlanyRecruiting
  • Progerint s.r.o.Recruiting
  • Aalborg Universitetshospital NordRecruiting
  • Gentofte HospitalRecruiting
  • Nordsjaellands Hospital - HillerodRecruiting
  • Hvidovre HospitalRecruiting
  • Odense UniversitetshospitalRecruiting
  • Sjællands University hospitalRecruiting
  • CHU de LimogesRecruiting
  • Hopital de La Croix RousseRecruiting
  • CHU Nimes - Hôpital CarémeauRecruiting
  • Centre hospitalier Lyon-SudRecruiting
  • CHU Saint-Etienne - Hôpital NordRecruiting
  • Universitätsklinikum JenaRecruiting
  • Familienmedizinisches Zentrum RadowskyRecruiting
  • SIBAmed GmbH & Co. KGRecruiting
  • Red-Institut für medizinische Forschung und FortbildungRecruiting
  • Praxis Dr. WeimerRecruiting
  • Universitaetsmedizin RostockRecruiting
  • Samson Assuta Ashdod University HospitalRecruiting
  • Hadassah Medical CenterRecruiting
  • The Chaim Sheba Medical CenterRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di ChietiRecruiting
  • Istituto Nazionale Tumori Regina Elena
  • Azienda Ospedaliera Sant AndreaRecruiting
  • Fukuoka Wajiro HospitalRecruiting
  • Fukuoka Shinmizumaki HospitalRecruiting
  • Matsunami General HospitalRecruiting
  • Teine Keijinkai HospitalRecruiting
  • Aso Co.,Ltd Iizuka HospitalRecruiting
  • Inoue HospitalRecruiting
  • Medical Corporation Toyoshikai Kano HospitalRecruiting
  • Japan Community Health care Organization Kyushu HospitalRecruiting
  • Shinkomonji hospitalRecruiting
  • JRC Nagasaki Genbaku HospitalRecruiting
  • Abe Diabetes ClinicRecruiting
  • Almeida Memorial HospitalRecruiting
  • National Hospital Organization Nagasaki Medical CenterRecruiting
  • Omuta City HospitalRecruiting
  • Japan Community Health Care Organization Osaka HospitalRecruiting
  • Kyobashi Sugimoto ClinicRecruiting
  • Sanuki Munincipal HospitalRecruiting
  • Teine Maeda Urology ClinicRecruiting
  • Teine Urological ClinicRecruiting
  • Nanbu Tokushukai HospitalRecruiting
  • Shimonoseki City HospitalRecruiting
  • Tokyo Shinagawa HospitalRecruiting
  • Suita Tokushukai HospitalRecruiting
  • Suwa Red Cross HospitalRecruiting
  • Japan Community Health Care Organization Kyusyu HospitalRecruiting
  • Shimonoseki City HospitalRecruiting
  • National Hospital Organization Yokohama Medical CenterRecruiting
  • Dong-A University HospitalRecruiting
  • Hallym University Chuncehon Medical Center
  • Chungnam National University HospitalRecruiting
  • Chunnam National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Korea University Ansan HospitalRecruiting
  • Inha University HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Kangbuk Samsung HospitalRecruiting
  • Asan Medical Center
  • Samsung Medical CenterRecruiting
  • Hallym University Sacred Heart HospitalRecruiting
  • Ewha Womans University Mokdong Hospital
  • The Catholic university of Korea, St. Vincent's HospitalRecruiting
  • WonJu Severance Christian Hospital
  • Leiden University Medical CenterRecruiting
  • ZiekenhuisRecruiting
  • The Julius Center - Utrecht Science Park - StratenumRecruiting
  • Southern Clinical Trials Totara Clinical ResearchRecruiting
  • Southern Clinical Trials LtdRecruiting
  • Optimal Clinical TrialsRecruiting
  • Tauranga Urology Research LimitedRecruiting
  • Southern Clinical Trials LtdRecruiting
  • Canterbury Urology Research TrustRecruiting
  • P3 Research LtdRecruiting
  • Lakeland Clinical TrialsRecruiting
  • P3 Research LtdRecruiting
  • P3 Research - Lower HuttRecruiting
  • Southern Clinical Trials LtdRecruiting
  • P3 Research LtdRecruiting
  • Culloden Research LtdRecruiting
  • Middlemore Clinical TrialsRecruiting
  • Optimal Clinical TrialsRecruiting
  • Lakeland Clinical TrialsRecruiting
  • P3 Research LtdRecruiting
  • Lakeland Clinical TrialsRecruiting
  • P3 Research Limited KapitiRecruiting
  • Capatial & Coast District Health BoardRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Hosp. Univ. de BellvitgeRecruiting
  • Hosp. Del Mar
  • Consorci D'Atenció Primària de Salut Barcelona EsquerraRecruiting
  • Hosp. Reina SofiaRecruiting
  • Hosp. Univ. Dr. Josep TruetaRecruiting
  • CAP Dr. Vicenç Papaceit ABS LA ROCA
  • Hosp. Univ. La PazRecruiting
  • Hospital Sanitas La MoralejaRecruiting
  • Hosp. Univ. Hm MonteprincipeRecruiting
  • Hosp. Quirónsalud Málaga
  • Complexo Hosp. Univ. de Ourense
  • Hosp. Univ. Son EspasesRecruiting
  • Corporacio Sanitari Parc TauliRecruiting
  • Hosp. Virgen MacarenaRecruiting
  • BTH Research & Development ClinicRecruiting
  • CTC EbbeparkRecruiting
  • Skanes universitetssjukhusRecruiting
  • ClinSmart Sweden ABRecruiting
  • ClinSmart Sweden ABRecruiting
  • Universitetssjukhuset OrebroRecruiting
  • Kaohsiung Veterans General HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Chang Gung Memorial Hospital Linkou BranchRecruiting
  • King Chulalongkorn Memorial HospitalRecruiting
  • Thai Red Cross Aids Research CentreRecruiting
  • Ramathibodi HospitalRecruiting
  • Tropical Medicine Hospital, Mahidol UniversityRecruiting
  • Siriraj HospitalRecruiting
  • Aberdeen Royal InfirmaryRecruiting
  • Atherstone SurgeryRecruiting
  • Banbury Cross Health CenterRecruiting
  • FutureMeds Bridle ClinicRecruiting
  • FutureMeds-Soho UKRecruiting
  • Blackpool Teaching Hospitals NHS Foundation TrustRecruiting
  • Royal Bournemouth HospitalRecruiting
  • North Bristol NHS TrustRecruiting
  • University Hospitals Bristol NHS TrustRecruiting
  • Royal Devon & Exeter NHS Foundation TrustRecruiting
  • Eynsham Medical CentreRecruiting
  • The Garth SurgeryRecruiting
  • University Hospitals Of Leicester Nhs TrustRecruiting
  • King's College Hospital NHS Foundation TrustRecruiting
  • Manchester Royal InfirmaryRecruiting
  • The NIHR Manchester Clinical Research FacilityRecruiting
  • South Tees Hospitals NHS Foundation TrustRecruiting
  • Nottingham University Hospitals NHS TrustRecruiting
  • Plymouth University Hospitals Trust
  • Ashgrove SurgeryRecruiting
  • The Adam PracticeRecruiting
  • Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
  • Midlands Partnership NHS Foundation TrustRecruiting
  • Mid Yorkshire Hospital NHS Trust- Pinderfields HospitalRecruiting
  • Church Street PracticeRecruiting
  • Windrush Medical PracticeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ExPEC9V

Placebo

Arm Description

Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.

Participants will receive a single IM injection of matching placebo on Day 1.

Outcomes

Primary Outcome Measures

Number of Participants with First Invasive Extraintestinal Pathogenic E.coli Disease(IED) Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (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 Participants with First IED Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by 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 All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes
Number of participants with 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 Participants with All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes
Number of participants with 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.
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
MRU for IED events will be reported.
MRU for UTI Events
MRU for UTI events (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)
Medical resource utilization for ABP events (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
Number of participants with hospitalization for IED or, UTI, or ABP events will be reported.
Length of Stay in Hospital for IED, UTI, or ABP Events
Length of stay in hospital for IED, UTI, or ABP events will be reported.
Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events
Number of participants with ICU hospitalization for IED or UTI or ABP events will be reported.
Length of ICU Stay in Hospital for IED, UTI, or ABP Events
Length of ICU stay in hospital for IED, UTI, or ABP events 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.

Full Information

First Posted
May 21, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04899336
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
May 19, 2025 (Anticipated)
Study Completion Date
May 14, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 3 years post-vaccination). The total study duration is approximately up to 6 years 11 months. Key safety assessments include serious adverse events (SAEs), solicited and unsolicited adverse events (AEs), physical examination, and vital signs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18556 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ExPEC9V
Arm Type
Experimental
Arm Description
Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IM injection of matching placebo on Day 1.
Intervention Type
Biological
Intervention Name(s)
ExPEC9V
Other Intervention Name(s)
VAC52416, JNJ-78901563
Intervention Description
ExPEC9V will be administered as an IM injection.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered as an IM injection.
Primary Outcome Measure Information:
Title
Number of Participants with First Invasive Extraintestinal Pathogenic E.coli Disease(IED) Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (ExPEC9V) O-serotypes
Description
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.
Time Frame
Up to 3 years
Title
Number of Participants with First IED Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by ExPEC9V O-serotypes
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Number of Participants with All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes
Description
Number of participants with all IEDs (including multiple IEDs per participant) caused by ExPEC9V O-serotypes will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with First Hospitalized IED Event Caused by ExPEC9V O-serotypes
Description
Number of participants with first hospitalized IED event caused by ExPEC9V O-serotypes will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with First IED Event Meeting Criteria for Sepsis Caused by ExPEC9V O-serotypes
Description
Number of participants with first IED event meeting criteria for sepsis caused by ExPEC9V O-serotypes will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with First Bacteremic IED Event Caused by ExPEC9V O-serotypes
Description
Number of participants with first bacteremic IED event caused by ExPEC9V O-serotypes will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with First Pyelonephritis Event Caused by ExPEC9V O-serotypes
Description
Number of participants with first pyelonephritis event caused by ExPEC9V O-serotypes will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with First Urinary Tract Infection (UTI) Event Caused by ExPEC9V O-serotypes
Description
Number of participants with first UTI event caused by ExPEC9V O-serotypes will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes
Description
Number of participants with all UTIs (including multiple UTIs per participant) caused by ExPEC9V O-serotypes will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with First IED Event Caused by Escherichia coli (E.coli)
Description
Number of participants with first IED event caused by E.coli will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with First Pyelonephritis Event caused By E.coli
Description
Number of participants with first pyelonephritis event caused by E.coli will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with First UTI Event caused by E.coli
Description
Number of participants with first UTI event caused by E.coli will be reported.
Time Frame
Up to 3 years
Title
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay
Description
Antibody titers to vaccine O-serotype antigens as determined by multiplex ECL-based immunoassay will be reported.
Time Frame
Up to 3 years
Title
Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay
Description
Antibody titers to EPA as determined by multiplex ECL-based immunoassay will be reported.
Time Frame
Up to 3 years
Title
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA)
Description
Antibody titers to vaccine O-serotype antigens as determined by MOPA will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with Solicited Local Adverse Events (AEs)
Description
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).
Time Frame
Up to Day 15 (until 14 days post-vaccination)
Title
Number of Participants with Solicited Systemic AEs
Description
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.
Time Frame
Up to Day 15 (until 14 days post-vaccination)
Title
Number of Participants with Unsolicited AEs
Description
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.
Time Frame
Up to Day 30 (until 29 days post-vaccination)
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 3 years
Title
Short Form-36 (SF-36) Total Scores
Description
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).
Time Frame
Up to 3 years
Title
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
Description
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).
Time Frame
Up to 3 years
Title
Change from Baseline in Frailty Index
Description
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.
Time Frame
Baseline to 3 years
Title
Medical Resource Utilization (MRU) for IED Events
Description
MRU for IED events will be reported.
Time Frame
Up to Day 366 Post-IED
Title
MRU for UTI Events
Description
MRU for UTI events (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.
Time Frame
Up to Day 29 Post-UTI
Title
MRU for Acute Bacterial Prostatitis (ABP)
Description
Medical resource utilization for ABP events (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.
Time Frame
Up to Day 29 Post-ABP
Title
Number of Participants with the Hospitalization for IED or, UTI, or ABP Events
Description
Number of participants with hospitalization for IED or, UTI, or ABP events will be reported.
Time Frame
Up to 3 years
Title
Length of Stay in Hospital for IED, UTI, or ABP Events
Description
Length of stay in hospital for IED, UTI, or ABP events will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events
Description
Number of participants with ICU hospitalization for IED or UTI or ABP events will be reported.
Time Frame
Up to 3 months
Title
Length of ICU Stay in Hospital for IED, UTI, or ABP Events
Description
Length of ICU stay in hospital for IED, UTI, or ABP events will be reported.
Time Frame
Up to 3 months
Title
Number of Participants with IED-related and All-cause Mortality
Description
Number of participants with IED-related and all-cause mortality will be reported.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Lakeview Clinical Research
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Individual Site Status
Recruiting
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85108
Country
United States
Individual Site Status
Recruiting
Facility Name
Interspond-Clinical Research Institute of AZ
City
Sun City West
State/Province
Arizona
ZIP/Postal Code
85357
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Hope clinical Research LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Recruiting
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
California Adult Circumcision - Alvarado La Mesa Urology Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Completed
Facility Name
Long Beach Clinical Trials, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Veterans Affairs Greater Los Angeles HCS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Name
VA Sacramento Medical Center
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Individual Site Status
Recruiting
Facility Name
Empire Clinical Research, LLC
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Recruiting
Facility Name
San Diego Sports Medicine & Family Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
California Kidney Specialists
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Clinical Trials, LLC
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Individual Site Status
Recruiting
Facility Name
San Antonio Regional Hospital
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Ideal Clinical Research
City
Adventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Bay Pines VA Healthcare System
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Individual Site Status
Recruiting
Facility Name
Nova Clinical Research, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of Brandon
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Moore Clinical Reseach - Brandon Clinic
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Medical Center of Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33755
Country
United States
Individual Site Status
Recruiting
Facility Name
Innovative Research of West Florida, Incorporated
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Clinical Research Network
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Prestige Clinical Research Center, Inc.
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Doral Medical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
Universal Axon Clinical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Medical Research Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
Indago Research & Health Center Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Prestige Clinical Research
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Individual Site Status
Recruiting
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinCloud Clinical Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Nova Clinical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Individual Site Status
Recruiting
Facility Name
Finlay Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Care Medical Research Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Recruiting
Facility Name
Retreat Medical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Name
Continental Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144-4273
Country
United States
Individual Site Status
Recruiting
Facility Name
Dynamic Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida International Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Health- Life Research Inst
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Office of Dr. Marisela Gonzalez
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Felicidad Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Individual Site Status
Recruiting
Facility Name
A&R Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Name
Alpha Science Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical NeuroScience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Individual Site Status
Recruiting
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Name
Pines Care Research Center Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of Central Florida
City
Plant City
State/Province
Florida
ZIP/Postal Code
33563
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access Research
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Theia Clincial Research, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Completed
Facility Name
Precision Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Joseph's Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Completed
Facility Name
Santos Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33625
Country
United States
Individual Site Status
Recruiting
Facility Name
Agile Clinical Research Trials, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Completed
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Completed
Facility Name
Snake River Research, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Name
Jesse Brown VAMC Department of Surgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Medisphere Medical Research Center, Llc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Individual Site Status
Recruiting
Facility Name
Asha Clinical Research-Munster Llc
City
Hammond
State/Province
Indiana
ZIP/Postal Code
46324
Country
United States
Individual Site Status
Recruiting
Facility Name
Mishawaka Osteopathic Clinic/MOC Research
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Individual Site Status
Recruiting
Facility Name
Cypress Medical Research Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Completed
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
KAMP Medical Research, Inc
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Individual Site Status
Recruiting
Facility Name
West Roxbury Veterans Affairs Medical Center
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132-4927
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
MediSync Clinical Research
City
Petal
State/Province
Mississippi
ZIP/Postal Code
39465
Country
United States
Individual Site Status
Completed
Facility Name
Meridian Clinical Research, LLC
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Recruiting
Facility Name
Hope Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Completed
Facility Name
Sierra Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Name
VA Sierra Nevada Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Individual Site Status
Completed
Facility Name
I.D. Care, Inc.
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Individual Site Status
Recruiting
Facility Name
Durham VAMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Individual Site Status
Recruiting
Facility Name
Plains Clinical Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Name
Kroger Health
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45458
Country
United States
Individual Site Status
Recruiting
Facility Name
Remington Davis Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Name
Kroger Health
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Individual Site Status
Recruiting
Facility Name
The Little Clinic
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Internal Medicine
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Individual Site Status
Completed
Facility Name
Tekton Research Inc.
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Individual Site Status
Recruiting
Facility Name
Capital Area Research
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Individual Site Status
Recruiting
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Name
Hugh D. Durrence, MD, PC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Individual Site Status
Recruiting
Facility Name
Waterway Familiy Medicine
City
Little River
State/Province
South Carolina
ZIP/Postal Code
29566
Country
United States
Individual Site Status
Recruiting
Facility Name
Novel Research LLC
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Medical Research - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Infectious Diseases Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Health Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting
Facility Name
EPIC Clinical Research
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Individual Site Status
Recruiting
Facility Name
SMS Clinical Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Be Well Clinical Studies
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Recruiting
Facility Name
Audie L Murphy Memorial Va Ho
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Sherman Clinical Research
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Individual Site Status
Recruiting
Facility Name
Lone Peak Family Medicine
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Alliance for Research and Education
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003-7347
Country
United States
Individual Site Status
Recruiting
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Individual Site Status
Recruiting
Facility Name
Infectious Disease Associates of Central Virginia
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Individual Site Status
Recruiting
Facility Name
IACT - Suffolk Multispecialty Research
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Individual Site Status
Recruiting
Facility Name
Selma Medical Associates
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Recruiting
Facility Name
Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney
City
Cheney
State/Province
Washington
ZIP/Postal Code
99004
Country
United States
Individual Site Status
Recruiting
Facility Name
Exemplar Research, Inc
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Recruiting
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Andrew's War Memorial Hospital
City
Brisbane
ZIP/Postal Code
4001
Country
Australia
Individual Site Status
Recruiting
Facility Name
GP Surgery - Campbelltown
City
Campbelltown
ZIP/Postal Code
5074
Country
Australia
Individual Site Status
Completed
Facility Name
Barwon Health - University Hospital Geelong
City
Geelong
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
CMAX Clinical Research
City
Melbourne
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Completed
Facility Name
John Hunter Hospital
City
New Lambton
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital
City
Palmyra DC
ZIP/Postal Code
6961
Country
Australia
Individual Site Status
Recruiting
Facility Name
McIntyre Medical Center
City
Para Hills West
ZIP/Postal Code
5096
Country
Australia
Individual Site Status
Completed
Facility Name
North West Medical Center
City
Salisbury
ZIP/Postal Code
5108
Country
Australia
Individual Site Status
Completed
Facility Name
Mater Medical Centre - South Brisbane
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Completed
Facility Name
Bene Aged Care - Italian Village
City
St Agnes
ZIP/Postal Code
5097
Country
Australia
Individual Site Status
Completed
Facility Name
Westmead Hospital
City
Sydney
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
AusTrials Pty Ltd
City
Taringa
ZIP/Postal Code
4068
Country
Australia
Individual Site Status
Completed
Facility Name
AusTrials Pty Ltd
City
Tarragindi
ZIP/Postal Code
4121
Country
Australia
Individual Site Status
Completed
Facility Name
Adelaide Medical Solutions
City
Woodville
ZIP/Postal Code
5011
Country
Australia
Individual Site Status
Completed
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G121
Country
Canada
Individual Site Status
Completed
Facility Name
CARe Clinical Ltd
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P 1K4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Vancouver ID Research and Care Centre Society
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z2C7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dawson Road Family Health Team
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 1B1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Bluewater Clinical Research Group Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Winchester District Memorial Hospital
City
Winchester
State/Province
Ontario
ZIP/Postal Code
K0C2K0
Country
Canada
Individual Site Status
Recruiting
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Individual Site Status
Recruiting
Facility Name
West China School of Medicine/West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Funan Center for Disease Control and Prevention
City
Fuyang
ZIP/Postal Code
236399
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Center for Disease Control and Prevention
City
Hefei
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Medical University
City
Nanjing
ZIP/Postal Code
211112
Country
China
Individual Site Status
Recruiting
Facility Name
Suzhou Municipal Hospital
City
Suzhou
ZIP/Postal Code
215002
Country
China
Individual Site Status
Recruiting
Facility Name
Uromeda
City
Brno
ZIP/Postal Code
61500
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Ordinace Hradebni s.r.o.
City
Ceske Budejovice
ZIP/Postal Code
37001
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi
City
Dolni Brezany
ZIP/Postal Code
252 41
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Centrum Ockovani a Cestovi Mediciny
City
Hradec Kralove
ZIP/Postal Code
50002
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Res Medica
City
Novy Knin
ZIP/Postal Code
262 03
Country
Czechia
Individual Site Status
Recruiting
Facility Name
PreventaMed, s.r.o.
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Recruiting
Facility Name
GYNURO s.r.o
City
Ostrava-Proskovice
ZIP/Postal Code
72400
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MUDr. Mita Rosenberg
City
Plzen 1
ZIP/Postal Code
323 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Ambulance name: Gynekologická ordinace MUDr
City
Plzeň
ZIP/Postal Code
30100
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Zdravi-fit, s.r.o.
City
Protivin
ZIP/Postal Code
39811
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Slany
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Progerint s.r.o.
City
Vysoke Myto
ZIP/Postal Code
56601
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Aalborg Universitetshospital Nord
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Nordsjaellands Hospital - Hillerod
City
Hilleroed
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense Universitetshospital
City
Odense M
ZIP/Postal Code
5230
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Sjællands University hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
CHU de Limoges
City
Limousis
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nimes - Hôpital Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Centre hospitalier Lyon-Sud
City
Pierre Benite cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Saint-Etienne - Hôpital Nord
City
Saint-Priest en Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Name
Familienmedizinisches Zentrum Radowsky
City
Leipzig
ZIP/Postal Code
04179
Country
Germany
Individual Site Status
Recruiting
Facility Name
SIBAmed GmbH & Co. KG
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Red-Institut für medizinische Forschung und Fortbildung
City
Oldenburg in Holstein
ZIP/Postal Code
23758
Country
Germany
Individual Site Status
Recruiting
Facility Name
Praxis Dr. Weimer
City
Reinfeld
ZIP/Postal Code
23858
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Name
Samson Assuta Ashdod University Hospital
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv-Yafo
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Ospedaliera Sant Andrea
City
Rome
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fukuoka Wajiro Hospital
City
Fukuoka-Shi
ZIP/Postal Code
811-0213
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka Shinmizumaki Hospital
City
Fukuoka
ZIP/Postal Code
807-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsunami General Hospital
City
Hashima-gun
ZIP/Postal Code
5016062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Teine Keijinkai Hospital
City
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Aso Co.,Ltd Iizuka Hospital
City
Iizuka
ZIP/Postal Code
820-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Inoue Hospital
City
Itoshima-City
ZIP/Postal Code
8191104
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical Corporation Toyoshikai Kano Hospital
City
Kasuya-gun
ZIP/Postal Code
811-3112
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japan Community Health care Organization Kyushu Hospital
City
Kitakyushu
ZIP/Postal Code
8000295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shinkomonji hospital
City
Kitakyusyu
ZIP/Postal Code
800-0057
Country
Japan
Individual Site Status
Recruiting
Facility Name
JRC Nagasaki Genbaku Hospital
City
Nagasaki-Shi
ZIP/Postal Code
852-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Abe Diabetes Clinic
City
Oita
ZIP/Postal Code
8700039
Country
Japan
Individual Site Status
Recruiting
Facility Name
Almeida Memorial Hospital
City
Oita
ZIP/Postal Code
8701195
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Omura
ZIP/Postal Code
856-8562
Country
Japan
Individual Site Status
Recruiting
Facility Name
Omuta City Hospital
City
Omuta-Shi
ZIP/Postal Code
836-0861
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japan Community Health Care Organization Osaka Hospital
City
Osaka City
ZIP/Postal Code
5530003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyobashi Sugimoto Clinic
City
Osaka-shi
ZIP/Postal Code
5340024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sanuki Munincipal Hospital
City
Sanuki
ZIP/Postal Code
7692393
Country
Japan
Individual Site Status
Recruiting
Facility Name
Teine Maeda Urology Clinic
City
Sapporo-Shi
ZIP/Postal Code
006-0812
Country
Japan
Individual Site Status
Recruiting
Facility Name
Teine Urological Clinic
City
Sapporo-Shi
ZIP/Postal Code
0060816
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nanbu Tokushukai Hospital
City
Shimajiri-Gun
ZIP/Postal Code
9010493
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shimonoseki City Hospital
City
Shimonoseki-shi
ZIP/Postal Code
7500061
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Shinagawa Hospital
City
Shinagawa City
ZIP/Postal Code
1408522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Suita Tokushukai Hospital
City
Suita-Shi
ZIP/Postal Code
5650814
Country
Japan
Individual Site Status
Recruiting
Facility Name
Suwa Red Cross Hospital
City
Suwa-Shi
ZIP/Postal Code
3928510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japan Community Health Care Organization Kyusyu Hospital
City
Yahatanishi-ku
ZIP/Postal Code
806-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shimonoseki City Hospital
City
Yamaguchi
ZIP/Postal Code
750-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Yokohama Medical Center
City
Yokohama
ZIP/Postal Code
245-8575
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-812
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hallym University Chuncehon Medical Center
City
ChunCheon
ZIP/Postal Code
24253
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chunnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22322
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul Teugbyeolsi
ZIP/Postal Code
8308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hallym University Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
The Catholic university of Korea, St. Vincent's Hospital
City
Suwon-si
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
WonJu Severance Christian Hospital
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Ziekenhuis
City
Uden
ZIP/Postal Code
5406 PT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
The Julius Center - Utrecht Science Park - Stratenum
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Southern Clinical Trials Totara Clinical Research
City
Auckland
ZIP/Postal Code
0600
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Southern Clinical Trials Ltd
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Optimal Clinical Trials
City
Auckland
ZIP/Postal Code
1011
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Tauranga Urology Research Limited
City
Bay Of Plenty
ZIP/Postal Code
3112
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Southern Clinical Trials Ltd
City
Christchurch Central
ZIP/Postal Code
8013
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Canterbury Urology Research Trust
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
P3 Research Ltd
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Lakeland Clinical Trials
City
Hamilton
ZIP/Postal Code
3200
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
P3 Research Ltd
City
Hastings
ZIP/Postal Code
4122
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
P3 Research - Lower Hutt
City
Lower Hutt
ZIP/Postal Code
5010
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Southern Clinical Trials Ltd
City
Nelson
ZIP/Postal Code
7011
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
P3 Research Ltd
City
Palmerston North
ZIP/Postal Code
4414
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Culloden Research Ltd
City
Papamoa
ZIP/Postal Code
3118
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Optimal Clinical Trials
City
Rosedale
ZIP/Postal Code
632
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Lakeland Clinical Trials
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
P3 Research Ltd
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Lakeland Clinical Trials
City
Upper Hutt
ZIP/Postal Code
5018
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
P3 Research Limited Kapiti
City
Wellington
ZIP/Postal Code
5032
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Capatial & Coast District Health Board
City
Wellington
ZIP/Postal Code
6242
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Individual Site Status
Completed
Facility Name
Consorci D'Atenció Primària de Salut Barcelona Esquerra
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
CAP Dr. Vicenç Papaceit ABS LA ROCA
City
La Roca del Valles
ZIP/Postal Code
8430
Country
Spain
Individual Site Status
Completed
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Sanitas La Moraleja
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Hm Monteprincipe
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Quirónsalud Málaga
City
Málaga
ZIP/Postal Code
29004
Country
Spain
Individual Site Status
Completed
Facility Name
Complexo Hosp. Univ. de Ourense
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Completed
Facility Name
Hosp. Univ. Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
BTH Research & Development Clinic
City
Karlskrona
ZIP/Postal Code
37179
Country
Sweden
Individual Site Status
Recruiting
Facility Name
CTC Ebbepark
City
Linkoaping
ZIP/Postal Code
582 13
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Skanes universitetssjukhus
City
Malmoe
ZIP/Postal Code
21428
Country
Sweden
Individual Site Status
Recruiting
Facility Name
ClinSmart Sweden AB
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Name
ClinSmart Sweden AB
City
Uppsala
ZIP/Postal Code
752 37
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Universitetssjukhuset Orebro
City
Örebro
ZIP/Postal Code
70362
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Thai Red Cross Aids Research Centre
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Tropical Medicine Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Atherstone Surgery
City
Atherstone
ZIP/Postal Code
CV9 1EU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Banbury Cross Health Center
City
Banbury
ZIP/Postal Code
OX16 9AD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
FutureMeds Bridle Clinic
City
Birkenhead
ZIP/Postal Code
CH62 6EE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
FutureMeds-Soho UK
City
Birmingham
ZIP/Postal Code
B21 0RY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Blackpool Teaching Hospitals NHS Foundation Trust
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
North Bristol NHS Trust
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Bristol NHS Trust
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Devon & Exeter NHS Foundation Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Eynsham Medical Centre
City
Eynsham
ZIP/Postal Code
OX29 4QB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Garth Surgery
City
Guisborough
ZIP/Postal Code
TS14 7DJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Of Leicester Nhs Trust
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The NIHR Manchester Clinical Research Facility
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Plymouth University Hospitals Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Ashgrove Surgery
City
Pontypridd
ZIP/Postal Code
CF37 2DR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Adam Practice
City
Poole
ZIP/Postal Code
BH15 4JQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2 JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Midlands Partnership NHS Foundation Trust
City
Stafford
ZIP/Postal Code
ST16 3SR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Church Street Practice
City
Wantage
ZIP/Postal Code
OX12 9BN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Windrush Medical Practice
City
Witney
ZIP/Postal Code
OX28 6JS
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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