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| ID | Type | Description | Link |
|---|---|---|---|
| VAC52416BAC3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-005273-27 | EudraCT Number | ||
| 2023-506589-30-00 | Registry Identifier | EUCT number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ExPEC9V | Experimental | Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1. |
|
| Placebo | Placebo Comparator | Participants will receive a single IM injection of matching placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExPEC9V | Biological | ExPEC9V will be administered as an IM injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with First Invasive Extraintestinal Pathogenic E.coli Disease (IED) Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (ExPEC9V) O-serotypes | Number of participants with first IED event with microbiological confirmation in blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes will be reported. | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with First IED Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by ExPEC9V O-serotypes | Number of participants with first IED event, with microbiological confirmation in blood, other sterile sites, or urine, caused by ExPEC9V O-serotypes will be reported. | Up to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeview Clinical Research | Guntersville | Alabama | 35976 | United States | ||
| Hope Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38704743 | Derived | Doiron RC, Cotechini T, Nickel JC. It's Time to Embrace Vaccination as We Enter the Postantibiotic Era of Recurrent Urinary Tract Infection Management. J Urol. 2024 Jun;211(6):797-799. doi: 10.1097/JU.0000000000003969. Epub 2024 May 5. No abstract available. | |
| 38236365 | Derived | Doua J, Ekkelenkamp M, Verheij T, Go O, Ruhmel S, Leathers K, Spiessens B, van Rooij S, Fowler VG Jr, Geurtsen J, Dolor R, Sarnecki M, Chatterjee R, Poolman J, Bonten M; on behalf COMBACTE-NET consortium/EXPECT study group. Feasibility of tracking invasive Escherichia coli disease among older adults in a community setting: A prospective observational study. Eur J Clin Microbiol Infect Dis. 2024 Mar;43(3):541-550. doi: 10.1007/s10096-023-04738-y. Epub 2024 Jan 18. |
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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
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| Placebo | Other | Matching placebo will be administered as an IM injection. |
|
| Number of All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes |
Number of all IEDs (including multiple IEDs per participant) caused by ExPEC9V O-serotypes will be reported. |
| Up to 4 years |
| 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. | Up to 4 years |
| 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. | Up to 4 years |
| 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. | Up to 4 years |
| 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. | Up to 4 years |
| 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. | Up to 3 years |
| Number of All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes | Number of all UTIs (including multiple UTIs per participant) caused by ExPEC9V O-serotypes will be reported. | Up to 3 years |
| 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. | Up to 4 years |
| 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. | Up to 4 years |
| 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. | Up to 3 years |
| 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. | Up to 4 years |
| Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay | Antibody titers to EPA as determined by multiplex ECL-based immunoassay will be reported. | Up to 4 years |
| Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA) | Antibody titers to vaccine O-serotype antigens as determined by MOPA will be reported. | Up to 4 years |
| 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). | Up to Day 15 (until 14 days post-vaccination) |
| 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. | Up to Day 15 (until 14 days post-vaccination) |
| 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. | Up to Day 30 (until 29 days post-vaccination) |
| 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. | Up to 181 days |
| Number of Participants with SAEs Related to Study Vaccine or Study Procedures | A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. Participants with SAEs related to study procedures or vaccines will be reported in this outcome measure. | Up to 4 years |
| 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). | Up to 4 years |
| 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). | Up to 4 years |
| 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. | Baseline to 4 years |
| Medical Resource Utilization (MRU) for IED Events Caused by ExPEC9V O-Serotype | MRU for IED events caused by ExPEC9V O-serotype will be reported. | Up to Day 366 Post-IED |
| MRU for UTI Events Caused by ExPEC9V O-Serotype | MRU for UTI events caused by ExPEC9V O-serotype (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported. | Up to Day 29 Post-UTI |
| MRU for Acute Bacterial Prostatitis (ABP) Events Caused by ExPEC9V O-Serotype | Medical resource utilization for ABP events caused by ExPEC9V O-serotype (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported. | Up to Day 29 Post-ABP |
| Number of Participants with the Hospitalization for IED or, UTI, or ABP Events Caused by ExPEC9V O-Serotype | Number of participants with hospitalization for IED or, UTI, or ABP events caused by ExPEC9V O-serotype will be reported. | Up to 4 years |
| Length of Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype | Length of stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported. | Up to 4 years |
| Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events Caused by ExPEC9V O-Serotype | Number of participants with ICU hospitalization for IED or UTI or ABP events caused by ExPEC9V O-serotype will be reported. | Up to 3 months post clinical event |
| Length of ICU Stay in Hospital for IED, UTI, or ABP Events Caused by ExPEC9V O-Serotype | Length of ICU stay in hospital for IED, UTI, or ABP events caused by ExPEC9V O-serotype will be reported. | Up to 3 months post clinical event |
| Number of Participants with IED-related and All-cause Mortality | Number of participants with IED-related and all-cause mortality will be reported. | Up to 4 years |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Hope Research Institute | Phoenix | Arizona | 85108 | United States |
| Interspond-Clinical Research Institute of AZ | Sun City West | Arizona | 85357 | United States |
| Baptist Health Center For Clinical Research | Little Rock | Arkansas | 72205 | United States |
| Sun Urology - Buena Park Office | Buena Park | California | 90621 | United States |
| Hope clinical Research LLC | Canoga Park | California | 91303 | United States |
| Velocity Clinical Research, Inc. | Chula Vista | California | 91911 | United States |
| Marvel Clinical Research | Huntington Beach | California | 92647 | United States |
| California Adult Circumcision - Alvarado La Mesa Urology Center | La Mesa | California | 91942 | United States |
| Om Research LLC | Lancaster | California | 93534 | United States |
| Atlantic Urology Medical Group | Long Beach | California | 90806-2766 | United States |
| Long Beach Clinical Trials, LLC | Long Beach | California | 90806 | United States |
| American Institute of Research | Los Angeles | California | 90017 | United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Southern California Permanente Medical Group | Los Angeles | California | 90027 | United States |
| Comprehensive Urology | Los Angeles | California | 90048 | United States |
| Veterans Affairs Greater Los Angeles HCS | Los Angeles | California | 90073 | United States |
| VA Sacramento Medical Center | Mather | California | 95655 | United States |
| Hoag Medical Group | Newport Beach | California | 92663 | United States |
| Kaiser Permanente Vaccine Study Center | Oakland | California | 94612 | United States |
| Empire Clinical Research, LLC | Pomona | California | 91767 | United States |
| Inland Urology Medical Group | Pomona | California | 91767 | United States |
| UC Davis Health System | Sacramento | California | 92647 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| San Diego Sports Medicine & Family Health Center | San Diego | California | 92120 | United States |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | United States |
| California Kidney Specialists | San Dimas | California | 91773 | United States |
| Prestige Medical Group | Santa Ana | California | 92705 | United States |
| Millennium Clinical Trials LLC | Simi Valley | California | 93065 | United States |
| San Antonio Regional Hospital | Upland | California | 91786 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Ideal Clinical Research | Adventura | Florida | 33180 | United States |
| Bay Pines VA Healthcare System | Bay Pines | Florida | 33744 | United States |
| Nova Clinical Research, LLC | Bradenton | Florida | 34209 | United States |
| Clinical Research of Brandon | Brandon | Florida | 33511 | United States |
| Moore Clinical Reseach - Brandon Clinic | Brandon | Florida | 33511 | United States |
| Florida Medical Center of Clearwater | Clearwater | Florida | 33755 | United States |
| Innovative Research of West Florida, Incorporated | Clearwater | Florida | 33756 | United States |
| Advanced Clinical Research Network | Coral Gables | Florida | 33134 | United States |
| Prestige Clinical Research Center, Inc. | Coral Gables | Florida | 33134 | United States |
| Accel Research Sites | DeLand | Florida | 32720 | United States |
| Doral Medical Research | Doral | Florida | 33166 | United States |
| Universal Axon Clinical Research | Doral | Florida | 33166 | United States |
| Florida Medical Research Institute | Gainesville | Florida | 32607 | United States |
| Indago Research & Health Center Inc | Hialeah | Florida | 33012 | United States |
| Prestige Clinical Research | Homestead | Florida | 33030 | United States |
| Multi Specialty Research Associates Inc | Lake City | Florida | 32055 | United States |
| ClinCloud Clinical Research | Maitland | Florida | 32751 | United States |
| Nova Clinical Research Center | Miami | Florida | 33124 | United States |
| Finlay Medical Research | Miami | Florida | 33126 | United States |
| Royal Care Medical Research Corporation | Miami | Florida | 33133 | United States |
| Retreat Medical Research LLC | Miami | Florida | 33135 | United States |
| Suncoast Research Group | Miami | Florida | 33135 | United States |
| Continental Research | Miami | Florida | 33144-4273 | United States |
| Dynamic Medical Research, LLC | Miami | Florida | 33144 | United States |
| Florida International Medical Research | Miami | Florida | 33155 | United States |
| Health- Life Research Inst | Miami | Florida | 33155 | United States |
| Office of Dr. Marisela Gonzalez | Miami | Florida | 33155 | United States |
| Felicidad Medical Research | Miami | Florida | 33185 | United States |
| A and R Research Group | Miami | Florida | 33186 | United States |
| Alpha Science Research | Miami | Florida | 33186 | United States |
| Clinical NeuroScience Solutions Inc | Orlando | Florida | 32801 | United States |
| Omega Research Consultants | Orlando | Florida | 32808 | United States |
| Pines Care Research Center Inc | Pembroke Pines | Florida | 33024 | United States |
| Clinical Research of Central Florida | Plant City | Florida | 33563 | United States |
| Care Access Research | Spring Hill | Florida | 34609 | United States |
| Tampa General Hospital | Tampa | Florida | 33603 | United States |
| Theia Clincial Research, LLC | Tampa | Florida | 33613 | United States |
| Precision Research Institute | Tampa | Florida | 33614 | United States |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | United States |
| Santos Research Center | Tampa | Florida | 33615 | United States |
| Care Access Research | Tampa | Florida | 33625 | United States |
| Agile Clinical Research Trials, LLC | Atlanta | Georgia | 30328 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | United States |
| Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion | Chicago | Illinois | 60611 | United States |
| Jesse Brown VAMC Department of Surgery | Chicago | Illinois | 60612 | United States |
| University Of Illinois | Chicago | Illinois | 60612 | United States |
| Medisphere Medical Research Center, Llc | Evansville | Indiana | 47714 | United States |
| Asha Clinical Research-Munster Llc | Hammond | Indiana | 46324 | United States |
| Mishawaka Osteopathic Clinic/MOC Research | Mishawaka | Indiana | 46544 | United States |
| Cypress Medical Research Center | Wichita | Kansas | 67226 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| KAMP Medical Research, Inc | Natchitoches | Louisiana | 71457 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Kaiser Permanente | Rockville | Maryland | 20852 | United States |
| Floating Hospital For Children at Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| West Roxbury Veterans Affairs Medical Center | West Roxbury | Massachusetts | 02132-4927 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| MediSync Clinical Research | Petal | Mississippi | 39465 | United States |
| Meridian Clinical Research, LLC | Grand Island | Nebraska | 68803 | United States |
| Be Well Clinical Studies | Lincoln | Nebraska | 68516 | United States |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | United States |
| Hope Research Institute | Las Vegas | Nevada | 89106 | United States |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | United States |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | United States |
| VA Sierra Nevada Health Care System | Reno | Nevada | 89509 | United States |
| I.D. Care, Inc. | Hillsborough | New Jersey | 08844 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Meridian Clinical Research, LLC | Binghamton | New York | 13901 | United States |
| Meridian Clinical Research, LLC | Endwell | New York | 13760 | United States |
| Manhattan Medical Research | New York | New York | 10016 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Durham VAMC | Durham | North Carolina | 27705 | United States |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28303 | United States |
| ECU Health Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| Plains Clinical Research | Fargo | North Dakota | 58104 | United States |
| Kroger Health | Centerville | Ohio | 45458 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Remington Davis Inc | Columbus | Ohio | 43215 | United States |
| Kroger Health | Englewood | Ohio | 45322 | United States |
| The Little Clinic | Englewood | Ohio | 45322 | United States |
| Comprehensive Internal Medicine | Wooster | Ohio | 44691 | United States |
| Tekton Research Inc. | Yukon | Oklahoma | 73099 | United States |
| Kaiser Permanente | Portland | Oregon | 97227 | United States |
| Capital Area Research | Camp Hill | Pennsylvania | 17011 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Hugh D. Durrence, MD, PC | Charleston | South Carolina | 29412 | United States |
| Waterway Familiy Medicine | Little River | South Carolina | 29566 | United States |
| Novel Research LLC | Bellaire | Texas | 77401 | United States |
| Global Medical Research - Dallas | Dallas | Texas | 75224 | United States |
| Medical City Dallas | Dallas | Texas | 75230 | United States |
| North Texas Infectious Diseases Consultants | Dallas | Texas | 75246 | United States |
| Digestive Health Associates | Houston | Texas | 77024 | United States |
| EPIC Clinical Research | Lewisville | Texas | 75057 | United States |
| SMS Clinical Research LLC | Mesquite | Texas | 75149 | United States |
| Be Well Clinical Studies | Round Rock | Texas | 78681 | United States |
| Audie L Murphy Memorial Va Ho | San Antonio | Texas | 78229 | United States |
| Sherman Clinical Research | Sherman | Texas | 75092 | United States |
| Lone Peak Family Medicine | Draper | Utah | 84020 | United States |
| Clinical Alliance for Research and Education | Annandale | Virginia | 22003-7347 | United States |
| Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | United States |
| Infectious Disease Associates of Central Virginia | Lynchburg | Virginia | 24501 | United States |
| IACT - Suffolk Multispecialty Research | Suffolk | Virginia | 23435 | United States |
| Selma Medical Associates | Winchester | Virginia | 22601 | United States |
| Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney | Cheney | Washington | 99004 | United States |
| Exemplar Research, Inc | Morgantown | West Virginia | 26505 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Saint Andrew's War Memorial Hospital | Brisbane | 4001 | Australia |
| GP Surgery - Campbelltown | Campbelltown | 5074 | Australia |
| Barwon Health - University Hospital Geelong | Geelong | 3220 | Australia |
| CMAX Clinical Research | Melbourne | 5000 | Australia |
| John Hunter Hospital | New Lambton | 2305 | Australia |
| Fiona Stanley Hospital | Palmyra DC | 6961 | Australia |
| McIntyre Medical Center | Para Hills West | 5096 | Australia |
| North West Medical Center | Salisbury | 5108 | Australia |
| Mater Medical Centre South Brisbane | South Brisbane | 4101 | Australia |
| Bene Aged Care - Italian Village | St Agnes | 5097 | Australia |
| Westmead Hospital | Sydney | 2145 | Australia |
| AusTrials Pty Ltd | Taringa | 4068 | Australia |
| AusTrials Pty Ltd | Tarragindi | 4121 | Australia |
| Adelaide Medical Solutions | Woodville | 5011 | Australia |
| CARe Clinical Ltd | Calgary | Alberta | T4P 1K4 | Canada |
| University of Alberta | Edmonton | Alberta | T6G121 | Canada |
| CARe Clinical Ltd | Red Deer | Alberta | T4P 1K4 | Canada |
| Vancouver ID Research and Care Centre Society | Vancouver | British Columbia | V6Z2C7 | Canada |
| Health Sciences North | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Dawson Road Family Health Team | Guelph | Ontario | N1H 1B1 | Canada |
| Bluewater Clinical Research Group Inc. | Sarnia | Ontario | N7T 4X3 | Canada |
| Winchester District Memorial Hospital | Winchester | Ontario | K0C2K0 | Canada |
| Alpha Recherche Clinique | Québec | Quebec | G2J 0C4 | Canada |
| Alpha Recherche Clinique | Québec | Quebec | G3K 2P8 | Canada |
| West China School of Medicine/West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Funan Center for Disease Control and Prevention | Fuyang | 236399 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510120 | China |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510260 | China |
| 1st Affiliated Hospital of Zhejiang University Medical College | Hangzhou | 310003 | China |
| Anhui Provincial Center for Disease Control and Prevention | Hefei | 230601 | China |
| Huoqiu County Center For Disease Control and Prevention | Liuan | 237400 | China |
| Jiangsu Provincial Center for Disease Control and Prevention | Nanjing | 210009 | China |
| Nanjing Medical University | Nanjing | 211112 | China |
| Huashan Hospital affiliated to Fudan University | Shanghai | 200040 | China |
| Suzhou Municipal Hospital | Suzhou | 215002 | China |
| Taizhou Peoples Hospital | Taizhou | 225300 | China |
| Yixing People's Hospital | Wuxi | 214200 | China |
| Clinica de la Costa | Barranquilla | 080001 | Colombia |
| IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S. | Barranquilla | 80020 | Colombia |
| Centro de Investigaciones y Proyectos en Neurociencias CIPNA | Barranquilla | Colombia |
| Centro de Atencion e Investigacion Medica S.A. - CAIMED | Casanare | 856010 | Colombia |
| Fundacion Cardiovascular de Colombia | Floridablanca | Colombia |
| Centro de Atencion e Investigacion Medica S.A. - CAIMED | Girardot | 252432 | Colombia |
| Centro de Atencion e Investigacion Medica S.A. - CAIMED | Helechos | Colombia |
| Asociacion IPS Medicos Internistas de Caldas | Manizales | 170001 | Colombia |
| CAIMED Acacias | Meta | 507001 | Colombia |
| Fundacion Centro de Investigaciones Clinicas IPS Cardiomet | Pereira | 660003 | Colombia |
| Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc | Villavicencio | 500001 | Colombia |
| Uromeda | Brno | 61500 | Czechia |
| Ordinace Hradebni s.r.o. | České Budějovice | 37001 | Czechia |
| Aesculap Ambulance sro - Zdravotni Stredisko Centrum Zdravi | Dolní Břežany | 252 41 | Czechia |
| Centrum Ockovani a Cestovi Mediciny | Hradec Králové | 50002 | Czechia |
| Res Medica | Nový Knín | 262 03 | Czechia |
| PreventaMed, s.r.o. | Olomouc | 77900 | Czechia |
| GYNURO s.r.o | Ostrava-Proskovice | 72400 | Czechia |
| Ambulance name: Gynekologická ordinace MUDr | Pilsen | 30100 | Czechia |
| MUDr. Mita Rosenberg | Pilsen | 323 00 | Czechia |
| Gona s.R.o- Orfinace Harov | Prague | 13000 | Czechia |
| Zdravi-fit, s.r.o. | Protivín | 39811 | Czechia |
| Nemocnice Slany | Slaný | 274 01 | Czechia |
| Progerint s.r.o. | Vysoké Mýto | 56601 | Czechia |
| Aalborg Universitetshospital Nord | Hellerup | 2900 | Denmark |
| Gentofte Hospital | Herlev | 2730 | Denmark |
| Nordsjaellands Hospital - Hillerod | Hilleroed | 3400 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Odense Universitetshospital | Odense M | 5230 | Denmark |
| Sjællands University hospital | Roskilde | 4000 | Denmark |
| Centre Hospitalier Annecy Genevois | Annecy | 74370 | France |
| CHU Dijon Bourgogne - Hopital Francois Mitterrand | Dijon | 21000 | France |
| CHU de Limoges | Limousis | 87042 | France |
| Hopital de La Croix Rousse | Lyon | 69004 | France |
| CHU Nimes Hopital Caremeau | Nîmes | 30029 | France |
| Centre hospitalier Lyon-Sud | Pierre-Bénite | 69495 | France |
| CHU Saint Etienne Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Universitatsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| Universitatsklinikum Jena | Jena | 07747 | Germany |
| Familienmedizinisches Zentrum Radowsky | Leipzig | 04179 | Germany |
| SIBAmed GmbH & Co. KG | Leipzig | 4103 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH | Marburg | 35037 | Germany |
| Red-Institut für medizinische Forschung und Fortbildung | Oldenburg in Holstein | 23758 | Germany |
| Praxis Dr. Weimer | Reinfeld | 23858 | Germany |
| Universitaetsmedizin Rostock | Rostock | 18057 | Germany |
| KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC) | Belagavi | 590010 | India |
| S. R. Kalla Memorial General Hospital | Jaipur | 302006 | India |
| Nil Ratan Sircar Medical College and Hospital | Kolkata | 700014 | India |
| Regency health super specialty hospital | Lucknow | 226022 | India |
| Asian Institute Of Medical Science | Mumbai | 421203 | India |
| Jagadguru Sri Shivarathreeshwara Academy of Higher Education and Research | Mysuru | 570015 | India |
| Indraprastha Apollo Hospital | New Delhi | 1100776 | India |
| Shree Giriraj Multispeciality Hospital | Rajkot | 360004 | India |
| Nirmal Hospital Pvt. Ltd. | Surat | 395002 | India |
| BAPS Pramukhswami Hospital | Surat | 395009 | India |
| Samson Assuta Ashdod University Hospital | Ashdod | 7747629 | Israel |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti | Chieti | 66100 | Italy |
| Istituto Nazionale Tumori Regina Elena | Roma | 00144 | Italy |
| Azienda Ospedaliera Sant Andrea | Rome | 00189 | Italy |
| Akashi Medical Center | Akashi Shi | 674 0063 | Japan |
| Fukuoka Shinmizumaki Hospital | Fukuoka | 807-0051 | Japan |
| Fukuoka Wajiro Hospital | Fukuoka | 811-0213 | Japan |
| Hakodate Goryoukaku Hospital | Hakodate | 040 8611 | Japan |
| Matsunami General Hospital | Hashima-gun | 5016062 | Japan |
| Teine Keijinkai Hospital | Hokkaido | 006-8555 | Japan |
| Aso Co.,Ltd Iizuka Hospital | Iizuka | 820-8501 | Japan |
| Inoue Hospital | Itoshima | 8191104 | Japan |
| Kano Hospital | Kasuya-gun | 811-3112 | Japan |
| Kanto Rosai Hospital | Kawasaki | 211-8510 | Japan |
| Shinkomonji hospital | Kitakyushu | 800-0057 | Japan |
| Japan Community Health care Organization Kyushu Hospital | Kitakyushu | 8000295 | Japan |
| JRC Nagasaki Genbaku Hospital | Nagasaki | 852-8511 | Japan |
| Kyoujinkai Clinic Komatsu | Neyagawa | 572-8567 | Japan |
| Omuta City Hospital | Omuta-Shi | 836-0861 | Japan |
| Kyobashi Sugimoto Clinic | Osaka | 5340024 | Japan |
| Japan Community Health Care Organization Osaka Hospital | Osaka | 5530003 | Japan |
| Abe Diabetes Clinic | Ōita | 8700039 | Japan |
| Almeida Memorial Hospital | Ōita | 8701195 | Japan |
| National Hospital Organization Nagasaki Medical Center | Ōmura | 856-8562 | Japan |
| National Hospital Organization Shikoku Cancer Center | Sanuki | 7692393 | Japan |
| Teine Maeda Urology Clinic | Sapporo | 006-0812 | Japan |
| Teine Urological Clinic | Sapporo | 0060816 | Japan |
| Nanbu Tokushukai Hospital | Shimajiri-Gun | 9010493 | Japan |
| Shimonoseki City Hospital | Shimonoseki-shi | 7500061 | Japan |
| Tokyo Shinagawa Hospital | Shinagawa City | 1408522 | Japan |
| Suita Tokushukai Hospital | Suita-Shi | 5650814 | Japan |
| Japanese Red Cross Society Suwa Hospital | Suwa-Shi | 3928510 | Japan |
| Japan Community Health care Organization Kyushu Hospital | Yahatanishi-ku | 806-8501 | Japan |
| Shimonoseki City Hospital | Yamaguchi | 750-0041 | Japan |
| Yokohama Rosai Hospital | Yokohama | 222-0036 | Japan |
| National Hospital Organization Yokohama Medical Center | Yokohama | 245-8575 | Japan |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Ziekenhuis | Uden | 5406 PT | Netherlands |
| The Julius Center - Utrecht Science Park - Stratenum | Utrecht | 3508 GA | Netherlands |
| Southern Clinical Trials Totara Clinical Research | Auckland | 0600 | New Zealand |
| Southern Clinical Trials Ltd | Auckland | 0626 | New Zealand |
| Optimal Clinical Trials | Auckland | 1011 | New Zealand |
| Tauranga Urology Research Limited | Bay of Plenty | 3112 | New Zealand |
| Canterbury Urology Research Trust | Christchurch | 8013 | New Zealand |
| Southern Clinical Trials Ltd | Christchurch Central | 8013 | New Zealand |
| P3 Research Ltd | Dunedin | 9016 | New Zealand |
| Lakeland Clinical Trials | Hamilton | 3200 | New Zealand |
| P3 Research Ltd | Hastings | 4122 | New Zealand |
| P3 Research - Lower Hutt | Lower Hutt | 5010 | New Zealand |
| Southern Clinical Trials Ltd | Nelson | 7011 | New Zealand |
| P3 Research Ltd | Palmerston North | 4414 | New Zealand |
| Culloden Research Ltd | Papamoa | 3118 | New Zealand |
| Middlemore Clinical Trials | Papatoetoe | 2025 | New Zealand |
| Optimal Clinical Trials | Rosedale | 632 | New Zealand |
| Lakeland Clinical Trials | Rotorua | 3010 | New Zealand |
| P3 Research Ltd | Tauranga | 3110 | New Zealand |
| Lakeland Clinical Trials | Upper Hutt | 5018 | New Zealand |
| P3 Research Limited Kapiti | Wellington | 5032 | New Zealand |
| Capatial & Coast District Health Board | Wellington | 6242 | New Zealand |
| Dong-A University Hospital | Busan | 602 812 | South Korea |
| Hallym University Chuncehon Medical Center | Chuncheon | 24253 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Chunnam National University Hospital | Gwangju | 501-757 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 15355 | South Korea |
| Inha University Hospital | Incheon | 22322 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hallym University Sacred Heart Hospital | Seoul | 07441 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Korea University Guro Hospital | Seoul | 8308 | South Korea |
| The Catholic university of Korea, St. Vincent's Hospital | Suwon | 16247 | South Korea |
| WonJu Severance Christian Hospital | Wŏnju | 220-701 | South Korea |
| Hosp. Gral. Univ. Dr. Balmis | Alicante | 3010 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Univ. de Bellvitge | Barcelona | 08907 | Spain |
| Hosp. Del Mar | Barcelona | 8003 | Spain |
| Consorci D'Atenció Primària de Salut Barcelona Esquerra | Barcelona | 8028 | Spain |
| Hosp Reina Sofia | Córdoba | 14004 | Spain |
| Hosp. Univ. Dr. Josep Trueta | Girona | 17007 | Spain |
| Hosp. de Jerez de La Frontera | Jerez de la Frontera | 11407 | Spain |
| CAP Dr. Vicenç Papaceit ABS LA ROCA | La Roca del Vallès | 8430 | Spain |
| Hosp. Univ. de La Princesa | Madrid | 28006 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hospital Sanitas La Moraleja | Madrid | 28050 | Spain |
| Hosp. Univ. Hm Monteprincipe | Madrid | 28660 | Spain |
| Hosp. Quirónsalud Málaga | Málaga | 29004 | Spain |
| Complexo Hosp. Univ. de Ourense | Ourense | 32005 | Spain |
| Hosp. Univ. Son Espases | Palma de Mallorca | 07120 | Spain |
| Corporacio Sanitari Parc Tauli | Sabadell | 08208 | Spain |
| Hosp. Virgen Macarena | Seville | 41009 | Spain |
| Hosp. Alvaro Cunqueiro | Vigo | 36312 | Spain |
| Helsingborgs lasarett | Helsingborg | 25187 | Sweden |
| BTH Research & Development Clinic | Karlskrona | 37179 | Sweden |
| CTC Ebbepark | Linkoaping | 582 13 | Sweden |
| Skanes universitetssjukhus | Malmö | 21428 | Sweden |
| CTC GoCo | Mölndal | 43153 | Sweden |
| Universitetssjukhuset Orebro | Örebro | 70362 | Sweden |
| ClinSmart Sweden AB | Solna | 171 64 | Sweden |
| ClinSmart Sweden AB | Uppsala | 752 37 | Sweden |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| Chang Gung Memorial Hospital Linkou Branch | Taoyuan | 333 | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Thai Red Cross Aids Research Centre | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Tropical Medicine Hospital, Mahidol University | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Aberdeen Royal Infirmary | Aberdeen | AB25 2ZN | United Kingdom |
| Atherstone Surgery | Atherstone | CV9 1EU | United Kingdom |
| Banbury Cross Health Center | Banbury | OX16 9AD | United Kingdom |
| FutureMeds Bridle Clinic | Birkenhead | CH62 6EE | United Kingdom |
| FutureMeds-Soho UK | Birmingham | B21 0RY | United Kingdom |
| Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool | FY3 8NR | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| North Bristol NHS Trust | Bristol | BS10 5NB | United Kingdom |
| University Hospitals Bristol NHS Trust | Bristol | BS2 8BJ | United Kingdom |
| Royal Devon & Exeter NHS Foundation Trust | Exeter | EX2 5DW | United Kingdom |
| Eynsham Medical Centre | Eynsham | OX29 4QB | United Kingdom |
| The Garth Surgery | Guisborough | TS14 7DJ | United Kingdom |
| University Hospitals Of Leicester Nhs Trust | Leicester | LE1 5WW | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| The NIHR Manchester Clinical Research Facility | Manchester | M23 9LT | United Kingdom |
| South Tees Hospitals NHS Foundation Trust | Middlesbrough | TS4 3BW | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Plymouth University Hospitals Trust | Plymouth | PL6 8DH | United Kingdom |
| Ashgrove Surgery | Pontypridd | CF37 2DR | United Kingdom |
| The Adam Practice | Poole | BH15 4JQ | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | S10 2 JF | United Kingdom |
| Midlands Partnership NHS Foundation Trust | Stafford | ST16 3SR | United Kingdom |
| North Tees Furturemeds | Stockton-on-Tees | TS19 8PE | United Kingdom |
| Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital | Wakefield | WF1 4DG | United Kingdom |
| Church Street Practice | Wantage | OX12 9BN | United Kingdom |
| Windrush Medical Practice | Witney | OX28 6JS | United Kingdom |