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
- Conditions
- Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
- Interventions
- Other: Placebo
- Registration Number
- NCT04899336
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 17935
- 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
- Participant has end-stage renal disease for which dialysis is required
- Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws
- Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy
- Participant has received any Escherichia coli (E. coli) or extraintestinal pathogenic Escherichia coli (ExPEC) vaccine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ExPEC9V ExPEC9V Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1. Placebo Placebo Participants will receive a single IM injection of matching placebo on Day 1.
- Primary Outcome Measures
Name Time Method 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 Up to 4 years Number of participants with first IED event with microbiological confirmation in blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes will be reported.
- Secondary Outcome Measures
Name Time Method Number of Participants with First IED Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by ExPEC9V O-serotypes Up to 4 years Number of participants with first IED event, with microbiological confirmation in blood, other sterile sites, or urine, caused by ExPEC9V O-serotypes will be reported.
Number of All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes Up to 4 years Number of all IEDs (including multiple IEDs per participant) caused by ExPEC9V O-serotypes will be reported.
Number of Participants with First Hospitalized IED Event Caused by ExPEC9V O-serotypes Up to 4 years 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 Up to 4 years 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 Up to 4 years 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 Up to 4 years 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 Up to 3 years Number of participants with first UTI event caused by ExPEC9V O-serotypes will be reported.
Number of All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes Up to 3 years Number of all UTIs (including multiple UTIs per participant) caused by ExPEC9V O-serotypes will be reported.
Number of Participants with First IED Event Caused by Escherichia coli (E.coli) Up to 4 years 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 Up to 4 years 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 Up to 3 years 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 Up to 4 years 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 Up to 4 years 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) Up to 4 years Antibody titers to vaccine O-serotype antigens as determined by MOPA will be reported.
Number of Participants with Solicited Local Adverse Events (AEs) Up to Day 15 (until 14 days post-vaccination) Number of participants with solicited local AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs. Participants will be asked to note in the diary occurrences of injection site pain/tenderness, erythema and swelling at the study vaccine injection site daily for 14 days post-vaccination (day of vaccination and the subsequent 14 days).
Number of Participants with Solicited Systemic AEs Up to Day 15 (until 14 days post-vaccination) Number of participants with solicited systemic AEs will be reported. Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 14 days post-vaccination (day of vaccination and the subsequent 14 days). Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Number of Participants with Unsolicited AEs Up to Day 30 (until 29 days post-vaccination) Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Number of Participants with Serious Adverse Events (SAEs) Up to 181 days A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Number of Participants with SAEs Related to Study Vaccine or Study Procedures Up to 4 years A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. Participants with SAEs related to study procedures or vaccines will be reported in this outcome measure.
Short Form-36 (SF-36) Total Scores Up to 4 years The SF-36 is a 36-item questionnaire with a recall period for all items of 1 week. The SF 36 version 2 includes 8 domains that measure physical functioning, role limitations due to physical health problems, bodily pain, general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and mental health (MH). The 8 domains can be aggregated into 2 summary scales that reflect physical and mental health: a physical component summary (PCS) and a mental component summary (MCS). Responses to all items are rated on a 3-, 5- or 6-point Likert scale. The scores range from 0 (lowest or worst possible level of functioning) to 100 (highest or best possible level of functioning).
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores Up to 4 years The EQ-5D-5L is a standardized measure of health status. It is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Change from Baseline in Frailty Index Baseline to 4 years Frailty will be assessed at baseline based on Short Physical Performance Battery (SPPB) score and will be calculated using participants self-reported information regarding health status (components of SF-36 and EQ-5D), and baseline health conditions collected through medical conditions of interest. The specific medical conditions of interest used for the calculation of the frailty index score will include: diabetes mellitus, history of myocardial infarction, congestive heart failure, hypertension, history of cerebrovascular disease (sequelae of stroke), chronic obstructive pulmonary disease (COPD), cancer, osteoarthritis or rheumatoid arthritis, gastric or duodenal ulcer, long term disability or handicap, hearing problems, migraine, cataract, and glaucoma. Total Frailty Index, ranging from 0 (not frail or best possible score) to 43 (frail or worst possible score), will be calculated as accumulation of individual's deficits.
Medical Resource Utilization (MRU) for IED Events Caused by ExPEC9V O-Serotype Up to Day 366 Post-IED MRU for IED events caused by ExPEC9V O-serotype will be reported.
MRU for UTI Events Caused by ExPEC9V O-Serotype Up to Day 29 Post-UTI MRU for UTI events caused by ExPEC9V O-serotype (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported.
MRU for Acute Bacterial Prostatitis (ABP) Events Caused by ExPEC9V O-Serotype Up to Day 29 Post-ABP Medical resource utilization for ABP events caused by ExPEC9V O-serotype (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported.
Number of Participants with the Hospitalization for IED or, UTI, or ABP Events Caused by ExPEC9V O-Serotype Up to 4 years Number of participants with hospitalization for IED or, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.
Length of Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype Up to 4 years Length of stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.
Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events Caused by ExPEC9V O-Serotype Up to 3 months post clinical event Number of participants with ICU hospitalization for IED or UTI or ABP events caused by ExPEC9V O-serotype will be reported.
Length of ICU Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype Up to 3 months post clinical event Length of ICU stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported.
Number of Participants with IED-related and All-cause Mortality Up to 4 years Number of participants with IED-related and all-cause mortality will be reported.
Trial Locations
- Locations (349)
Ashgrove Surgery
🇬🇧Pontypridd, United Kingdom
The Adam Practice
🇬🇧Poole, United Kingdom
Nil Ratan Sircar Medical College and Hospital
🇮🇳Kolkata, India
Regency health super specialty hospital
🇮🇳Lucknow, India
Ziekenhuis
🇳🇱Uden, Netherlands
Helsingborgs lasarett
🇸🇪Helsingborg, Sweden
BTH Research & Development Clinic
🇸🇪Karlskrona, Sweden
CTC Ebbepark
🇸🇪Linkoaping, Sweden
Skanes universitetssjukhus
🇸🇪Malmoe, Sweden
CTC GoCo
🇸🇪Molndal, Sweden
Continental Research
🇺🇸Miami, Florida, United States
ClinSmart Sweden AB
🇸🇪Uppsala, Sweden
Universitetssjukhuset Orebro
🇸🇪Örebro, Sweden
Dynamic Medical Research, LLC
🇺🇸Miami, Florida, United States
Lakeview Clinical Research
🇺🇸Guntersville, Alabama, United States
Hope Research Institute
🇺🇸Las Vegas, Nevada, United States
Interspond-Clinical Research Institute of AZ
🇺🇸Sun City West, Arizona, United States
Baptist Health Center For Clinical Research
🇺🇸Little Rock, Arkansas, United States
Sun Urology - Buena Park Office
🇺🇸Buena Park, California, United States
Hope clinical Research LLC
🇺🇸Canoga Park, California, United States
Velocity Clinical Research, Inc.
🇺🇸Chula Vista, California, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
California Adult Circumcision - Alvarado La Mesa Urology Center
🇺🇸La Mesa, California, United States
Om Research LLC
🇺🇸Lancaster, California, United States
California Kidney Specialists
🇺🇸San Dimas, California, United States
Atlantic Urology Medical Group
🇺🇸Long Beach, California, United States
Long Beach Clinical Trials, LLC
🇺🇸Long Beach, California, United States
American Institute of Research
🇺🇸Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Southern California Permanente Medical Group
🇺🇸Los Angeles, California, United States
Comprehensive Urology
🇺🇸Los Angeles, California, United States
Veterans Affairs Greater Los Angeles HCS
🇺🇸Los Angeles, California, United States
VA Sacramento Medical Center
🇺🇸Mather, California, United States
Hoag Medical Group
🇺🇸Newport Beach, California, United States
Kaiser Permanente Vaccine Study Center
🇺🇸Oakland, California, United States
Empire Clinical Research, LLC
🇺🇸Pomona, California, United States
Inland Urology Medical Group
🇺🇸Pomona, California, United States
UC Davis Health System
🇺🇸Sacramento, California, United States
Northern California Research
🇺🇸Sacramento, California, United States
San Diego Sports Medicine & Family Health Center
🇺🇸San Diego, California, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Prestige Medical Group
🇺🇸Santa Ana, California, United States
Millennium Clinical Trials LLC
🇺🇸Simi Valley, California, United States
San Antonio Regional Hospital
🇺🇸Upland, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Ideal Clinical Research
🇺🇸Adventura, Florida, United States
Bay Pines VA Healthcare System
🇺🇸Bay Pines, Florida, United States
Nova Clinical Research, LLC
🇺🇸Bradenton, Florida, United States
Clinical Research of Brandon
🇺🇸Brandon, Florida, United States
Moore Clinical Reseach - Brandon Clinic
🇺🇸Brandon, Florida, United States
Florida Medical Center of Clearwater
🇺🇸Clearwater, Florida, United States
Innovative Research of West Florida, Incorporated
🇺🇸Clearwater, Florida, United States
Advanced Clinical Research Network
🇺🇸Coral Gables, Florida, United States
Prestige Clinical Research Center, Inc.
🇺🇸Coral Gables, Florida, United States
Accel Research Sites
🇺🇸DeLand, Florida, United States
Doral Medical Research
🇺🇸Doral, Florida, United States
Universal Axon Clinical Research
🇺🇸Doral, Florida, United States
Florida Medical Research Institute
🇺🇸Gainesville, Florida, United States
Indago Research & Health Center Inc
🇺🇸Hialeah, Florida, United States
Prestige Clinical Research
🇺🇸Homestead, Florida, United States
Multi Specialty Research Associates Inc
🇺🇸Lake City, Florida, United States
ClinCloud Clinical Research
🇺🇸Maitland, Florida, United States
Nova Clinical Research Center
🇺🇸Miami, Florida, United States
Finlay Medical Research
🇺🇸Miami, Florida, United States
Royal Care Medical Research Corporation
🇺🇸Miami, Florida, United States
Retreat Medical Research LLC
🇺🇸Miami, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
S. R. Kalla Memorial General Hospital
🇮🇳Jaipur, India
Florida International Medical Research
🇺🇸Miami, Florida, United States
Health- Life Research Inst
🇺🇸Miami, Florida, United States
Office of Dr. Marisela Gonzalez
🇺🇸Miami, Florida, United States
Felicidad Medical Research
🇺🇸Miami, Florida, United States
A and R Research Group
🇺🇸Miami, Florida, United States
Alpha Science Research
🇺🇸Miami, Florida, United States
Clinical NeuroScience Solutions Inc
🇺🇸Orlando, Florida, United States
Omega Research Consultants
🇺🇸Orlando, Florida, United States
Pines Care Research Center Inc
🇺🇸Pembroke Pines, Florida, United States
Clinical Research of Central Florida
🇺🇸Plant City, Florida, United States
Care Access Research
🇺🇸Tampa, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Theia Clincial Research, LLC
🇺🇸Tampa, Florida, United States
Precision Research Institute
🇺🇸Tampa, Florida, United States
St. Joseph's Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
Santos Research Center
🇺🇸Tampa, Florida, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Atlanta VA Medical Center
🇺🇸Decatur, Georgia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Snake River Research, PLLC
🇺🇸Idaho Falls, Idaho, United States
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
🇺🇸Chicago, Illinois, United States
Jesse Brown VAMC Department of Surgery
🇺🇸Chicago, Illinois, United States
University Of Illinois
🇺🇸Chicago, Illinois, United States
Medisphere Medical Research Center, Llc
🇺🇸Evansville, Indiana, United States
Asha Clinical Research-Munster Llc
🇺🇸Hammond, Indiana, United States
Mishawaka Osteopathic Clinic/MOC Research
🇺🇸Mishawaka, Indiana, United States
Cypress Medical Research Center
🇺🇸Wichita, Kansas, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
KAMP Medical Research, Inc
🇺🇸Natchitoches, Louisiana, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Kaiser Permanente
🇺🇸Portland, Oregon, United States
Floating Hospital For Children at Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
West Roxbury Veterans Affairs Medical Center
🇺🇸West Roxbury, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
MediSync Clinical Research
🇺🇸Petal, Mississippi, United States
Meridian Clinical Research, LLC
🇺🇸Endwell, New York, United States
Be Well Clinical Studies
🇺🇸Round Rock, Texas, United States
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
VA Sierra Nevada Health Care System
🇺🇸Reno, Nevada, United States
I.D. Care, Inc.
🇺🇸Hillsborough, New Jersey, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Manhattan Medical Research
🇺🇸New York, New York, United States
Durham VAMC
🇺🇸Durham, North Carolina, United States
Carolina Institute for Clinical Research
🇺🇸Fayetteville, North Carolina, United States
ECU Health Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
Plains Clinical Research
🇺🇸Fargo, North Dakota, United States
Kroger Health
🇺🇸Englewood, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Remington Davis Inc
🇺🇸Columbus, Ohio, United States
The Little Clinic
🇺🇸Englewood, Ohio, United States
Comprehensive Internal Medicine
🇺🇸Wooster, Ohio, United States
Tekton Research Inc.
🇺🇸Yukon, Oklahoma, United States
Capital Area Research
🇺🇸Camp Hill, Pennsylvania, United States
Reading Hospital
🇺🇸West Reading, Pennsylvania, United States
Hugh D. Durrence, MD, PC
🇺🇸Charleston, South Carolina, United States
Waterway Familiy Medicine
🇺🇸Little River, South Carolina, United States
Novel Research LLC
🇺🇸Bellaire, Texas, United States
Global Medical Research - Dallas
🇺🇸Dallas, Texas, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
North Texas Infectious Diseases Consultants
🇺🇸Dallas, Texas, United States
Digestive Health Associates
🇺🇸Houston, Texas, United States
EPIC Clinical Research
🇺🇸Lewisville, Texas, United States
SMS Clinical Research LLC
🇺🇸Mesquite, Texas, United States
Audie L Murphy Memorial Va Ho
🇺🇸San Antonio, Texas, United States
Sherman Clinical Research
🇺🇸Sherman, Texas, United States
Lone Peak Family Medicine
🇺🇸Draper, Utah, United States
Clinical Alliance for Research and Education
🇺🇸Annandale, Virginia, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
Infectious Disease Associates of Central Virginia
🇺🇸Lynchburg, Virginia, United States
IACT - Suffolk Multispecialty Research
🇺🇸Suffolk, Virginia, United States
Selma Medical Associates
🇺🇸Winchester, Virginia, United States
Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney
🇺🇸Cheney, Washington, United States
Exemplar Research, Inc
🇺🇸Morgantown, West Virginia, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Saint Andrew's War Memorial Hospital
🇦🇺Brisbane, Australia
GP Surgery - Campbelltown
🇦🇺Campbelltown, Australia
Barwon Health - University Hospital Geelong
🇦🇺Geelong, Australia
CMAX Clinical Research
🇦🇺Melbourne, Australia
John Hunter Hospital
🇦🇺New Lambton, Australia
Fiona Stanley Hospital
🇦🇺Palmyra DC, Australia
McIntyre Medical Center
🇦🇺Para Hills West, Australia
North West Medical Center
🇦🇺Salisbury, Australia
Mater Medical Centre South Brisbane
🇦🇺South Brisbane, Australia
Bene Aged Care - Italian Village
🇦🇺St Agnes, Australia
Westmead Hospital
🇦🇺Sydney, Australia
AusTrials Pty Ltd
🇦🇺Tarragindi, Australia
Adelaide Medical Solutions
🇦🇺Woodville, Australia
CARe Clinical Ltd
🇨🇦Red Deer, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Vancouver ID Research and Care Centre Society
🇨🇦Vancouver, British Columbia, Canada
Dawson Road Family Health Team
🇨🇦Guelph, Ontario, Canada
Bluewater Clinical Research Group Inc.
🇨🇦Sarnia, Ontario, Canada
Health Sciences North
🇨🇦Sudbury, Ontario, Canada
Winchester District Memorial Hospital
🇨🇦Winchester, Ontario, Canada
Alpha Recherche Clinique
🇨🇦Quebec, Canada
West China School of Medicine/West China Hospital, Sichuan University
🇨🇳Chengdu, China
Funan Center for Disease Control and Prevention
🇨🇳Fuyang, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
1st Affiliated Hospital of Zhejiang University Medical College
🇨🇳Hangzhou, China
Anhui Provincial Center for Disease Control and Prevention
🇨🇳Hefei, China
Huoqiu County Center For Disease Control and Prevention
🇨🇳Liuan, China
Jiangsu Provincial Center for Disease Control and Prevention
🇨🇳Nanjing, China
Nanjing Medical University
🇨🇳Nanjing, China
Huashan Hospital affiliated to Fudan University
🇨🇳Shanghai, China
Suzhou Municipal Hospital
🇨🇳Suzhou, China
Taizhou Peoples Hospital
🇨🇳Taizhou, China
Yixing People's Hospital
🇨🇳Wuxi, China
Clinica de la Costa
🇨🇴Barranquilla, Colombia
IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
🇨🇴Barranquilla, Colombia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
🇨🇴Barranquilla, Colombia
Centro de Atencion e Investigacion Medica S.A. - CAIMED
🇨🇴Helechos, Colombia
Fundacion Cardiovascular de Colombia
🇨🇴Floridablanca, Colombia
Asociacion IPS Medicos Internistas de Caldas
🇨🇴Manizales, Colombia
CAIMED Acacias
🇨🇴Meta, Colombia
Fundacion Centro de Investigaciones Clinicas IPS Cardiomet
🇨🇴Pereira, Colombia
Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc
🇨🇴Villavicencio, Colombia
Uromeda
🇨🇿Brno, Czechia
Ordinace Hradebni s.r.o.
🇨🇿Ceske Budejovice, Czechia
Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi
🇨🇿Dolni Brezany, Czechia
Centrum Ockovani a Cestovi Mediciny
🇨🇿Hradec Kralove, Czechia
Res Medica
🇨🇿Novy Knin, Czechia
PreventaMed, s.r.o.
🇨🇿Olomouc, Czechia
GYNURO s.r.o
🇨🇿Ostrava-Proskovice, Czechia
MUDr. Mita Rosenberg
🇨🇿Plzen 1, Czechia
Ambulance name: Gynekologická ordinace MUDr
🇨🇿Plzeň, Czechia
Gona s.R.o- Orfinace Harov
🇨🇿Praha 3, Czechia
Zdravi-fit, s.r.o.
🇨🇿Protivin, Czechia
Nemocnice Slany
🇨🇿Slany, Czechia
Progerint s.r.o.
🇨🇿Vysoke Myto, Czechia
Aalborg Universitetshospital Nord
🇩🇰Hellerup, Denmark
Gentofte Hospital
🇩🇰Herlev, Denmark
Nordsjaellands Hospital - Hillerod
🇩🇰Hilleroed, Denmark
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Odense Universitetshospital
🇩🇰Odense M, Denmark
Sjællands University hospital
🇩🇰Roskilde, Denmark
Centre Hospitalier Annecy Genevois
🇫🇷Annecy, France
CHU Dijon Bourgogne - Hopital Francois Mitterrand
🇫🇷Dijon, France
CHU de Limoges
🇫🇷Limousis, France
Hopital de La Croix Rousse
🇫🇷Lyon, France
CHU Nimes Hopital Caremeau
🇫🇷Nîmes, France
Centre hospitalier Lyon-Sud
🇫🇷Pierre Benite cedex, France
CHU Saint Etienne Hopital Nord
🇫🇷Saint-Priest en Jarez, France
Universitatsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Universitatsklinikum Jena
🇩🇪Jena, Germany
Familienmedizinisches Zentrum Radowsky
🇩🇪Leipzig, Germany
SIBAmed GmbH & Co. KG
🇩🇪Leipzig, Germany
Universitaetsklinikum Giessen und Marburg GmbH
🇩🇪Marburg, Germany
Red-Institut für medizinische Forschung und Fortbildung
🇩🇪Oldenburg in Holstein, Germany
Praxis Dr. Weimer
🇩🇪Reinfeld, Germany
Universitaetsmedizin Rostock
🇩🇪Rostock, Germany
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)
🇮🇳Belagavi, India
Asian Institute Of Medical Science
🇮🇳Mumbai, India
Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research
🇮🇳Mysuru, India
Indraprastha Apollo Hospital
🇮🇳New Delhi, India
Shree Giriraj Multispeciality Hospital
🇮🇳Rajkot, India
Nirmal Hospital Pvt. Ltd.
🇮🇳Surat, India
BAPS Pramukhswami Hospital
🇮🇳Surat, India
Samson Assuta Ashdod University Hospital
🇮🇱Ashdod, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
The Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv Yafo, Israel
ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
🇮🇹Chieti, Italy
Istituto Nazionale Tumori Regina Elena
🇮🇹Roma, Italy
Azienda Ospedaliera Sant Andrea
🇮🇹Rome, Italy
Akashi Medical Center
🇯🇵Akashi shi, Japan
Fukuoka Wajiro Hospital
🇯🇵Fukuoka-Shi, Japan
Fukuoka Shinmizumaki Hospital
🇯🇵Fukuoka, Japan
Hakodate Goryoukaku Hospital
🇯🇵Hakodate, Japan
Matsunami General Hospital
🇯🇵Hashima-gun, Japan
Teine Keijinkai Hospital
🇯🇵Hokkaido, Japan
Aso Co.,Ltd Iizuka Hospital
🇯🇵Iizuka, Japan
Inoue Hospital
🇯🇵Itoshima-City, Japan
Kano Hospital
🇯🇵Kasuya-gun, Japan
Kanto Rosai Hospital
🇯🇵Kawasaki, Japan
Japan Community Health care Organization Kyushu Hospital
🇯🇵Yahatanishi-ku, Japan
Shinkomonji hospital
🇯🇵Kitakyusyu, Japan
JRC Nagasaki Genbaku Hospital
🇯🇵Nagasaki-Shi, Japan
Kyoujinkai Clinic Komatsu
🇯🇵Neyagawa, Japan
Abe Diabetes Clinic
🇯🇵Oita, Japan
Almeida Memorial Hospital
🇯🇵Oita, Japan
National Hospital Organization Nagasaki Medical Center
🇯🇵Omura, Japan
Omuta City Hospital
🇯🇵Omuta-Shi, Japan
Japan Community Health Care Organization Osaka Hospital
🇯🇵Osaka City, Japan
Kyobashi Sugimoto Clinic
🇯🇵Osaka-shi, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Sanuki, Japan
Teine Maeda Urology Clinic
🇯🇵Sapporo-Shi, Japan
Teine Urological Clinic
🇯🇵Sapporo-Shi, Japan
Nanbu Tokushukai Hospital
🇯🇵Shimajiri-Gun, Japan
Shimonoseki City Hospital
🇯🇵Yamaguchi, Japan
Tokyo Shinagawa Hospital
🇯🇵Shinagawa City, Japan
Suita Tokushukai Hospital
🇯🇵Suita-Shi, Japan
Japanese Red Cross Society Suwa Hospital
🇯🇵Suwa-Shi, Japan
Yokohama Rosai Hospital
🇯🇵Yokohama, Japan
National Hospital Organization Yokohama Medical Center
🇯🇵Yokohama, Japan
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Hallym University Chuncehon Medical Center
🇰🇷ChunCheon, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Chunnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul Teugbyeolsi, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic university of Korea, St. Vincent's Hospital
🇰🇷Suwon si, Korea, Republic of
WonJu Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Leiden University Medical Center
🇳🇱Leiden, Netherlands
The Julius Center - Utrecht Science Park - Stratenum
🇳🇱Utrecht, Netherlands
Southern Clinical Trials Totara Clinical Research
🇳🇿Auckland, New Zealand
Southern Clinical Trials Ltd
🇳🇿Nelson, New Zealand
Optimal Clinical Trials
🇳🇿Rosedale, New Zealand
Tauranga Urology Research Limited
🇳🇿Bay Of Plenty, New Zealand
Canterbury Urology Research Trust
🇳🇿Christchurch, New Zealand
P3 Research Ltd
🇳🇿Tauranga, New Zealand
Lakeland Clinical Trials
🇳🇿Upper Hutt, New Zealand
P3 Research - Lower Hutt
🇳🇿Lower Hutt, New Zealand
Culloden Research Ltd
🇳🇿Papamoa, New Zealand
Middlemore Clinical Trials
🇳🇿Papatoetoe, New Zealand
P3 Research Limited Kapiti
🇳🇿Wellington, New Zealand
Capatial & Coast District Health Board
🇳🇿Wellington, New Zealand
Hosp. Gral. Univ. Dr. Balmis
🇪🇸Alicante, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Hosp. Univ. de Bellvitge
🇪🇸Barcelona, Spain
Hosp. Del Mar
🇪🇸Barcelona, Spain
Consorci D'Atenció Primària de Salut Barcelona Esquerra
🇪🇸Barcelona, Spain
Hosp Reina Sofia
🇪🇸Córdoba, Spain
Hosp. Univ. Dr. Josep Trueta
🇪🇸Girona, Spain
Hosp. de Jerez de La Frontera
🇪🇸Jerez de la Frontera, Spain
CAP Dr. Vicenç Papaceit ABS LA ROCA
🇪🇸La Roca del Valles, Spain
Hosp. Univ. de La Princesa
🇪🇸Madrid, Spain
Hosp. Univ. La Paz
🇪🇸Madrid, Spain
Hospital Sanitas La Moraleja
🇪🇸Madrid, Spain
Hosp. Univ. Hm Monteprincipe
🇪🇸Madrid, Spain
Hosp. Quirónsalud Málaga
🇪🇸Málaga, Spain
Complexo Hosp. Univ. de Ourense
🇪🇸Ourense, Spain
Hosp. Univ. Son Espases
🇪🇸Palma de Mallorca, Spain
Corporacio Sanitari Parc Tauli
🇪🇸Sabadell, Spain
Hosp. Virgen Macarena
🇪🇸Sevilla, Spain
Hosp. Alvaro Cunqueiro
🇪🇸Vigo, Spain
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Chang Gung Memorial Hospital Linkou Branch
🇨🇳Taoyuan, Taiwan
King Chulalongkorn Memorial Hospital
🇹🇭Bangkok, Thailand
Thai Red Cross Aids Research Centre
🇹🇭Bangkok, Thailand
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Tropical Medicine Hospital, Mahidol University
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bangkok, Thailand
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Atherstone Surgery
🇬🇧Atherstone, United Kingdom
Banbury Cross Health Center
🇬🇧Banbury, United Kingdom
FutureMeds Bridle Clinic
🇬🇧Birkenhead, United Kingdom
FutureMeds-Soho UK
🇬🇧Birmingham, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
🇬🇧Blackpool, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
North Bristol NHS Trust
🇬🇧Bristol, United Kingdom
University Hospitals Bristol NHS Trust
🇬🇧Bristol, United Kingdom
Royal Devon & Exeter NHS Foundation Trust
🇬🇧Exeter, United Kingdom
Eynsham Medical Centre
🇬🇧Eynsham, United Kingdom
The Garth Surgery
🇬🇧Guisborough, United Kingdom
University Hospitals Of Leicester Nhs Trust
🇬🇧Leicester, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
The NIHR Manchester Clinical Research Facility
🇬🇧Manchester, United Kingdom
South Tees Hospitals NHS Foundation Trust
🇬🇧Middlesbrough, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Plymouth University Hospitals Trust
🇬🇧Plymouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Midlands Partnership NHS Foundation Trust
🇬🇧Stafford, United Kingdom
North Tees Furturemeds
🇬🇧Stockton-on-Tees, United Kingdom
Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
🇬🇧Wakefield, United Kingdom
Church Street Practice
🇬🇧Wantage, United Kingdom
Windrush Medical Practice
🇬🇧Witney, United Kingdom