Clinical trial NCT04899336: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 17935
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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

Primary outcomes:
measure: 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
timeFrame: Up to 4 years
Secondary outcomes:
measure: Number of Participants with First IED Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by ExPEC9V O-serotypes
timeFrame: Up to 4 years
measure: Number of All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes
timeFrame: Up to 4 years
measure: Number of Participants with First Hospitalized IED Event Caused by ExPEC9V O-serotypes
timeFrame: Up to 4 years
measure: Number of Participants with First IED Event Meeting Criteria for Sepsis Caused by ExPEC9V O-serotypes
timeFrame: Up to 4 years
measure: Number of Participants with First Bacteremic IED Event Caused by ExPEC9V O-serotypes
timeFrame: Up to 4 years
measure: Number of Participants with First Pyelonephritis Event Caused by ExPEC9V O-serotypes
timeFrame: Up to 4 years
measure: Number of Participants with First Urinary Tract Infection (UTI) Event Caused by ExPEC9V O-serotypes
timeFrame: Up to 3 years
measure: Number of All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes
timeFrame: Up to 3 years
measure: Number of Participants with First IED Event Caused by Escherichia coli (E.coli)
timeFrame: Up to 4 years
measure: Number of Participants with First Pyelonephritis Event caused By E.coli
timeFrame: Up to 4 years
measure: Number of Participants with First UTI Event caused by E.coli
timeFrame: Up to 3 years
measure: Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay
timeFrame: Up to 4 years
measure: Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay
timeFrame: Up to 4 years
measure: Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA)
timeFrame: Up to 4 years
measure: Number of Participants with Solicited Local Adverse Events (AEs)
timeFrame: Up to Day 15 (until 14 days post-vaccination)
measure: Number of Participants with Solicited Systemic AEs
timeFrame: Up to Day 15 (until 14 days post-vaccination)
measure: Number of Participants with Unsolicited AEs
timeFrame: Up to Day 30 (until 29 days post-vaccination)
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 181 days
measure: Number of Participants with SAEs Related to Study Vaccine or Study Procedures
timeFrame: Up to 4 years
measure: Short Form-36 (SF-36) Total Scores
timeFrame: Up to 4 years
measure: European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
timeFrame: Up to 4 years
measure: Change from Baseline in Frailty Index
timeFrame: Baseline to 4 years
measure: Medical Resource Utilization (MRU) for IED Events Caused by ExPEC9V O-Serotype
timeFrame: Up to Day 366 Post-IED
measure: MRU for UTI Events Caused by ExPEC9V O-Serotype
timeFrame: Up to Day 29 Post-UTI
measure: MRU for Acute Bacterial Prostatitis (ABP) Events Caused by ExPEC9V O-Serotype
timeFrame: Up to Day 29 Post-ABP
measure: Number of Participants with the Hospitalization for IED or, UTI, or ABP Events Caused by ExPEC9V O-Serotype
timeFrame: Up to 4 years
measure: Length of Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype
timeFrame: Up to 4 years
measure: Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events Caused by ExPEC9V O-Serotype
timeFrame: Up to 3 months post clinical event
measure: Length of ICU Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype
timeFrame: Up to 3 months post clinical event
measure: Number of Participants with IED-related and All-cause Mortality
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Sun City West
country: United States
facility: Interspond-Clinical Research Institute of AZ
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center For Clinical Research
state: Arkansas
city: Buena Park
country: United States
facility: Sun Urology - Buena Park Office
state: California
city: Canoga Park
country: United States
facility: Hope clinical Research LLC
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research, Inc.
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: La Mesa
country: United States
facility: California Adult Circumcision - Alvarado La Mesa Urology Center
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials, LLC
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Los Angeles
country: United States
facility: Comprehensive Urology
state: California
city: Los Angeles
country: United States
facility: Veterans Affairs Greater Los Angeles HCS
state: California
city: Mather
country: United States
facility: VA Sacramento Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Medical Group
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Vaccine Study Center
state: California
city: Pomona
country: United States
facility: Empire Clinical Research, LLC
state: California
city: Pomona
country: United States
facility: Inland Urology Medical Group
state: California
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine & Family Health Center
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: San Dimas
country: United States
facility: California Kidney Specialists
state: California
city: Santa Ana
country: United States
facility: Prestige Medical Group
state: California
city: Simi Valley
country: United States
facility: Millennium Clinical Trials LLC
state: California
city: Upland
country: United States
facility: San Antonio Regional Hospital
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Adventura
country: United States
facility: Ideal Clinical Research
state: Florida
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Bradenton
country: United States
facility: Nova Clinical Research, LLC
state: Florida
city: Brandon
country: United States
facility: Clinical Research of Brandon
state: Florida
city: Brandon
country: United States
facility: Moore Clinical Reseach - Brandon Clinic
state: Florida
city: Clearwater
country: United States
facility: Florida Medical Center of Clearwater
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Incorporated
state: Florida
city: Coral Gables
country: United States
facility: Advanced Clinical Research Network
state: Florida
city: Coral Gables
country: United States
facility: Prestige Clinical Research Center, Inc.
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites
state: Florida
city: Doral
country: United States
facility: Doral Medical Research
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center Inc
state: Florida
city: Homestead
country: United States
facility: Prestige Clinical Research
state: Florida
city: Lake City
country: United States
facility: Multi Specialty Research Associates Inc
state: Florida
city: Maitland
country: United States
facility: ClinCloud Clinical Research
state: Florida
city: Miami
country: United States
facility: Nova Clinical Research Center
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: Royal Care Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: Retreat Medical Research LLC
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: Continental Research
state: Florida
city: Miami
country: United States
facility: Dynamic Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Florida International Medical Research
state: Florida
city: Miami
country: United States
facility: Health- Life Research Inst
state: Florida
city: Miami
country: United States
facility: Office of Dr. Marisela Gonzalez
state: Florida
city: Miami
country: United States
facility: Felicidad Medical Research
state: Florida
city: Miami
country: United States
facility: A and R Research Group
state: Florida
city: Miami
country: United States
facility: Alpha Science Research
state: Florida
city: Orlando
country: United States
facility: Clinical NeuroScience Solutions Inc
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center Inc
state: Florida
city: Plant City
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Spring Hill
country: United States
facility: Care Access Research
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Theia Clincial Research, LLC
state: Florida
city: Tampa
country: United States
facility: Precision Research Institute
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Comprehensive Research Institute
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Tampa
country: United States
facility: Care Access Research
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Chicago
country: United States
facility: Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VAMC Department of Surgery
state: Illinois
city: Chicago
country: United States
facility: University Of Illinois
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center, Llc
state: Indiana
city: Hammond
country: United States
facility: Asha Clinical Research-Munster Llc
state: Indiana
city: Mishawaka
country: United States
facility: Mishawaka Osteopathic Clinic/MOC Research
state: Indiana
city: Wichita
country: United States
facility: Cypress Medical Research Center
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Natchitoches
country: United States
facility: KAMP Medical Research, Inc
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Rockville
country: United States
facility: Kaiser Permanente
state: Maryland
city: Boston
country: United States
facility: Floating Hospital For Children at Tufts Medical Center
state: Massachusetts
city: West Roxbury
country: United States
facility: West Roxbury Veterans Affairs Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Petal
country: United States
facility: MediSync Clinical Research
state: Mississippi
city: Grand Island
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Hope Research Institute
state: Nevada
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: Hillsborough
country: United States
facility: I.D. Care, Inc.
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Binghamton
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Greenville
country: United States
facility: ECU Health Vidant Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Plains Clinical Research
state: North Dakota
city: Centerville
country: United States
facility: Kroger Health
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Remington Davis Inc
state: Ohio
city: Englewood
country: United States
facility: Kroger Health
state: Ohio
city: Englewood
country: United States
facility: The Little Clinic
state: Ohio
city: Wooster
country: United States
facility: Comprehensive Internal Medicine
state: Ohio
city: Yukon
country: United States
facility: Tekton Research Inc.
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente
state: Oregon
city: Camp Hill
country: United States
facility: Capital Area Research
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Hugh D. Durrence, MD, PC
state: South Carolina
city: Little River
country: United States
facility: Waterway Familiy Medicine
state: South Carolina
city: Bellaire
country: United States
facility: Novel Research LLC
state: Texas
city: Dallas
country: United States
facility: Global Medical Research - Dallas
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants
state: Texas
city: Houston
country: United States
facility: Digestive Health Associates
state: Texas
city: Lewisville
country: United States
facility: EPIC Clinical Research
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research LLC
state: Texas
city: Round Rock
country: United States
facility: Be Well Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Audie L Murphy Memorial Va Ho
state: Texas
city: Sherman
country: United States
facility: Sherman Clinical Research
state: Texas
city: Draper
country: United States
facility: Lone Peak Family Medicine
state: Utah
city: Annandale
country: United States
facility: Clinical Alliance for Research and Education
state: Virginia
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Lynchburg
country: United States
facility: Infectious Disease Associates of Central Virginia
state: Virginia
city: Suffolk
country: United States
facility: IACT - Suffolk Multispecialty Research
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Cheney
country: United States
facility: Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney
state: Washington
city: Morgantown
country: United States
facility: Exemplar Research, Inc
state: West Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Brisbane
country: Australia
facility: Saint Andrew's War Memorial Hospital
city: Campbelltown
country: Australia
facility: GP Surgery - Campbelltown
city: Geelong
country: Australia
facility: Barwon Health - University Hospital Geelong
city: Melbourne
country: Australia
facility: CMAX Clinical Research
city: New Lambton
country: Australia
facility: John Hunter Hospital
city: Palmyra DC
country: Australia
facility: Fiona Stanley Hospital
city: Para Hills West
country: Australia
facility: McIntyre Medical Center
city: Salisbury
country: Australia
facility: North West Medical Center
city: South Brisbane
country: Australia
facility: Mater Medical Centre South Brisbane
city: St Agnes
country: Australia
facility: Bene Aged Care - Italian Village
city: Sydney
country: Australia
facility: Westmead Hospital
city: Taringa
country: Australia
facility: AusTrials Pty Ltd
city: Tarragindi
country: Australia
facility: AusTrials Pty Ltd
city: Woodville
country: Australia
facility: Adelaide Medical Solutions
city: Calgary
country: Canada
facility: CARe Clinical Ltd
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Red Deer
country: Canada
facility: CARe Clinical Ltd
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver ID Research and Care Centre Society
state: British Columbia
city: Guelph
country: Canada
facility: Dawson Road Family Health Team
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Winchester
country: Canada
facility: Winchester District Memorial Hospital
state: Ontario
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Chengdu
country: China
facility: West China School of Medicine/West China Hospital, Sichuan University
city: Fuyang
country: China
facility: Funan Center for Disease Control and Prevention
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: 1st Affiliated Hospital of Zhejiang University Medical College
city: Hefei
country: China
facility: Anhui Provincial Center for Disease Control and Prevention
city: Liuan
country: China
facility: Huoqiu County Center For Disease Control and Prevention
city: Nanjing
country: China
facility: Jiangsu Provincial Center for Disease Control and Prevention
city: Nanjing
country: China
facility: Nanjing Medical University
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
city: Taizhou
country: China
facility: Taizhou Peoples Hospital
city: Wuxi
country: China
facility: Yixing People's Hospital
city: Barranquilla
country: Colombia
facility: Clinica de la Costa
city: Barranquilla
country: Colombia
facility: IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA
city: Casanare
country: Colombia
facility: Centro de Atencion e Investigacion Medica S.A. - CAIMED
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia
city: Girardot
country: Colombia
facility: Centro de Atencion e Investigacion Medica S.A. - CAIMED
city: Helechos
country: Colombia
facility: Centro de Atencion e Investigacion Medica S.A. - CAIMED
city: Manizales
country: Colombia
facility: Asociacion IPS Medicos Internistas de Caldas
city: Meta
country: Colombia
facility: CAIMED Acacias
city: Pereira
country: Colombia
facility: Fundacion Centro de Investigaciones Clinicas IPS Cardiomet
city: Villavicencio
country: Colombia
facility: Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc
city: Brno
country: Czechia
facility: Uromeda
city: Ceske Budejovice
country: Czechia
facility: Ordinace Hradebni s.r.o.
city: Dolni Brezany
country: Czechia
facility: Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi
city: Hradec Kralove
country: Czechia
facility: Centrum Ockovani a Cestovi Mediciny
city: Novy Knin
country: Czechia
facility: Res Medica
city: Olomouc
country: Czechia
facility: PreventaMed, s.r.o.
city: Ostrava-Proskovice
country: Czechia
facility: GYNURO s.r.o
city: Plzen 1
country: Czechia
facility: MUDr. Mita Rosenberg
city: Plzeň
country: Czechia
facility: Ambulance name: Gynekologická ordinace MUDr
city: Praha 3
country: Czechia
facility: Gona s.R.o- Orfinace Harov
city: Protivin
country: Czechia
facility: Zdravi-fit, s.r.o.
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Vysoke Myto
country: Czechia
facility: Progerint s.r.o.
city: Hellerup
country: Denmark
facility: Aalborg Universitetshospital Nord
city: Herlev
country: Denmark
facility: Gentofte Hospital
city: Hilleroed
country: Denmark
facility: Nordsjaellands Hospital - Hillerod
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense M
country: Denmark
facility: Odense Universitetshospital
city: Roskilde
country: Denmark
facility: Sjællands University hospital
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Dijon
country: France
facility: CHU Dijon Bourgogne - Hopital Francois Mitterrand
city: Limousis
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hopital de La Croix Rousse
city: Nîmes
country: France
facility: CHU Nimes Hopital Caremeau
city: Pierre Benite cedex
country: France
facility: Centre hospitalier Lyon-Sud
city: Saint-Priest en Jarez
country: France
facility: CHU Saint Etienne Hopital Nord
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Leipzig
country: Germany
facility: Familienmedizinisches Zentrum Radowsky
city: Leipzig
country: Germany
facility: SIBAmed GmbH & Co. KG
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Oldenburg in Holstein
country: Germany
facility: Red-Institut für medizinische Forschung und Fortbildung
city: Reinfeld
country: Germany
facility: Praxis Dr. Weimer
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Belagavi
country: India
facility: KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)
city: Jaipur
country: India
facility: S. R. Kalla Memorial General Hospital
city: Kolkata
country: India
facility: Nil Ratan Sircar Medical College and Hospital
city: Lucknow
country: India
facility: Regency health super specialty hospital
city: Mumbai
country: India
facility: Asian Institute Of Medical Science
city: Mysuru
country: India
facility: Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research
city: New Delhi
country: India
facility: Indraprastha Apollo Hospital
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
city: Surat
country: India
facility: Nirmal Hospital Pvt. Ltd.
city: Surat
country: India
facility: BAPS Pramukhswami Hospital
city: Ashdod
country: Israel
facility: Samson Assuta Ashdod University Hospital
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Chieti
country: Italy
facility: ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant Andrea
city: Akashi shi
country: Japan
facility: Akashi Medical Center
city: Fukuoka-Shi
country: Japan
facility: Fukuoka Wajiro Hospital
city: Fukuoka
country: Japan
facility: Fukuoka Shinmizumaki Hospital
city: Hakodate
country: Japan
facility: Hakodate Goryoukaku Hospital
city: Hashima-gun
country: Japan
facility: Matsunami General Hospital
city: Hokkaido
country: Japan
facility: Teine Keijinkai Hospital
city: Iizuka
country: Japan
facility: Aso Co.,Ltd Iizuka Hospital
city: Itoshima-City
country: Japan
facility: Inoue Hospital
city: Kasuya-gun
country: Japan
facility: Kano Hospital
city: Kawasaki
country: Japan
facility: Kanto Rosai Hospital
city: Kitakyushu
country: Japan
facility: Japan Community Health care Organization Kyushu Hospital
city: Kitakyusyu
country: Japan
facility: Shinkomonji hospital
city: Nagasaki-Shi
country: Japan
facility: JRC Nagasaki Genbaku Hospital
city: Neyagawa
country: Japan
facility: Kyoujinkai Clinic Komatsu
city: Oita
country: Japan
facility: Abe Diabetes Clinic
city: Oita
country: Japan
facility: Almeida Memorial Hospital
city: Omura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
city: Omuta-Shi
country: Japan
facility: Omuta City Hospital
city: Osaka City
country: Japan
facility: Japan Community Health Care Organization Osaka Hospital
city: Osaka-shi
country: Japan
facility: Kyobashi Sugimoto Clinic
city: Sanuki
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Sapporo-Shi
country: Japan
facility: Teine Maeda Urology Clinic
city: Sapporo-Shi
country: Japan
facility: Teine Urological Clinic
city: Shimajiri-Gun
country: Japan
facility: Nanbu Tokushukai Hospital
city: Shimonoseki-shi
country: Japan
facility: Shimonoseki City Hospital
city: Shinagawa City
country: Japan
facility: Tokyo Shinagawa Hospital
city: Suita-Shi
country: Japan
facility: Suita Tokushukai Hospital
city: Suwa-Shi
country: Japan
facility: Japanese Red Cross Society Suwa Hospital
city: Yahatanishi-ku
country: Japan
facility: Japan Community Health care Organization Kyushu Hospital
city: Yamaguchi
country: Japan
facility: Shimonoseki City Hospital
city: Yokohama
country: Japan
facility: Yokohama Rosai Hospital
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: ChunCheon
country: Korea, Republic of
facility: Hallym University Chuncehon Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chunnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul Teugbyeolsi
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Suwon si
country: Korea, Republic of
facility: The Catholic university of Korea, St. Vincent's Hospital
city: Wonju
country: Korea, Republic of
facility: WonJu Severance Christian Hospital
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Uden
country: Netherlands
facility: Ziekenhuis
city: Utrecht
country: Netherlands
facility: The Julius Center - Utrecht Science Park - Stratenum
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Totara Clinical Research
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Ltd
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Bay Of Plenty
country: New Zealand
facility: Tauranga Urology Research Limited
city: Christchurch Central
country: New Zealand
facility: Southern Clinical Trials Ltd
city: Christchurch
country: New Zealand
facility: Canterbury Urology Research Trust
city: Dunedin
country: New Zealand
facility: P3 Research Ltd
city: Hamilton
country: New Zealand
facility: Lakeland Clinical Trials
city: Hastings
country: New Zealand
facility: P3 Research Ltd
city: Lower Hutt
country: New Zealand
facility: P3 Research - Lower Hutt
city: Nelson
country: New Zealand
facility: Southern Clinical Trials Ltd
city: Palmerston North
country: New Zealand
facility: P3 Research Ltd
city: Papamoa
country: New Zealand
facility: Culloden Research Ltd
city: Papatoetoe
country: New Zealand
facility: Middlemore Clinical Trials
city: Rosedale
country: New Zealand
facility: Optimal Clinical Trials
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials
city: Tauranga
country: New Zealand
facility: P3 Research Ltd
city: Upper Hutt
country: New Zealand
facility: Lakeland Clinical Trials
city: Wellington
country: New Zealand
facility: P3 Research Limited Kapiti
city: Wellington
country: New Zealand
facility: Capatial & Coast District Health Board
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. Dr. Balmis
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp. Univ. de Bellvitge
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Barcelona
country: Spain
facility: Consorci D'Atenció Primària de Salut Barcelona Esquerra
city: Córdoba
country: Spain
facility: Hosp Reina Sofia
city: Girona
country: Spain
facility: Hosp. Univ. Dr. Josep Trueta
city: Jerez de la Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: La Roca del Valles
country: Spain
facility: CAP Dr. Vicenç Papaceit ABS LA ROCA
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Madrid
country: Spain
facility: Hospital Sanitas La Moraleja
city: Madrid
country: Spain
facility: Hosp. Univ. Hm Monteprincipe
city: Málaga
country: Spain
facility: Hosp. Quirónsalud Málaga
city: Ourense
country: Spain
facility: Complexo Hosp. Univ. de Ourense
city: Palma de Mallorca
country: Spain
facility: Hosp. Univ. Son Espases
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Helsingborg
country: Sweden
facility: Helsingborgs lasarett
city: Karlskrona
country: Sweden
facility: BTH Research & Development Clinic
city: Linkoaping
country: Sweden
facility: CTC Ebbepark
city: Malmoe
country: Sweden
facility: Skanes universitetssjukhus
city: Molndal
country: Sweden
facility: CTC GoCo
city: Solna
country: Sweden
facility: ClinSmart Sweden AB
city: Uppsala
country: Sweden
facility: ClinSmart Sweden AB
city: Örebro
country: Sweden
facility: Universitetssjukhuset Orebro
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Thai Red Cross Aids Research Centre
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Tropical Medicine Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Atherstone
country: United Kingdom
facility: Atherstone Surgery
city: Banbury
country: United Kingdom
facility: Banbury Cross Health Center
city: Birkenhead
country: United Kingdom
facility: FutureMeds Bridle Clinic
city: Birmingham
country: United Kingdom
facility: FutureMeds-Soho UK
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Trust
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
city: Eynsham
country: United Kingdom
facility: Eynsham Medical Centre
city: Guisborough
country: United Kingdom
facility: The Garth Surgery
city: Leicester
country: United Kingdom
facility: University Hospitals Of Leicester Nhs Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: The NIHR Manchester Clinical Research Facility
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Plymouth
country: United Kingdom
facility: Plymouth University Hospitals Trust
city: Pontypridd
country: United Kingdom
facility: Ashgrove Surgery
city: Poole
country: United Kingdom
facility: The Adam Practice
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Stafford
country: United Kingdom
facility: Midlands Partnership NHS Foundation Trust
city: Stockton-on-Tees
country: United Kingdom
facility: North Tees Furturemeds
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
city: Wantage
country: United Kingdom
facility: Church Street Practice
city: Witney
country: United Kingdom
facility: Windrush Medical Practice
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: