Clostridium Difficile Vaccine Efficacy Trial

NCT ID: NCT03090191

Last Updated: 2023-02-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

17535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-29

Study Completion Date

2021-12-21

Brief Summary

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The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.

Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

Detailed Description

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Conditions

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Clostridium Difficile Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clostridium difficile vaccine

Group Type EXPERIMENTAL

Clostridium difficile vaccine

Intervention Type BIOLOGICAL

Toxoid-based Clostridium difficile vaccine

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Normal saline solution (0.9% sodium chloride)

Interventions

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Clostridium difficile vaccine

Toxoid-based Clostridium difficile vaccine

Intervention Type BIOLOGICAL

Placebo

Normal saline solution (0.9% sodium chloride)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Evidence of a personally signed and dated informed consent document.
* Willing and able to comply with study procedures.
* Subjects with an increased risk of future contact with healthcare systems or subjects who have received systemic antibiotics in the previous 12 weeks.
* Ability to be contacted by telephone during study participation.
* Negative urine pregnancy test for female subjects of childbearing potential.

Exclusion Criteria

* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
* Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
* Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
* Prior episode of CDI..
* Receipt of blood products or immunoglobulins within 6 months before enrollment.
* Subjects who may be unable to respond to vaccination due to:

* Metastatic malignancy; or
* End-stage renal disease; or
* Any serious medical disorder likely to be fatal within the next 12 months; or
* Congenital or acquired immunodeficiency; or
* Receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or
* Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
* Known infection with human immunodeficiency virus (HIV).
* Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
* Prior small- or large-bowel resection.
* Any condition or treatment resulting in frequent diarrhea.
* Other acute or chronic condition or abnormality that may increase the risk associated with study participation or IP administration or may interfere with interpretation of study results
* Pregnant or breastfeeding female subjects; male subjects and female subjects who are sexually active and at risk for pregnancy and will not/cannot use 2 methods of contraception
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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North Alabama Research Center, LLC

Athens, Alabama, United States

Site Status

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, United States

Site Status

Coastal Clinical Research, LLC, An AMR Company

Mobile, Alabama, United States

Site Status

The Pain Center of Arizona

Peoria, Arizona, United States

Site Status

Phoenix VA Health Care System

Phoenix, Arizona, United States

Site Status

Phoenix Clinical LLC

Phoenix, Arizona, United States

Site Status

MedPharmics, LLC

Phoenix, Arizona, United States

Site Status

Hope Research Institute

Phoenix, Arizona, United States

Site Status

The Pain Center of Arizona

Phoenix, Arizona, United States

Site Status

Clinical Research Institute of Arizona, LLC

Surprise, Arizona, United States

Site Status

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Site Status

Baptist Health Rehabilitation Institute

Little Rock, Arkansas, United States

Site Status

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Site Status

California Kidney Specialist

Covina, California, United States

Site Status

Usborne Family Medicine

Covina, California, United States

Site Status

Kaiser Permanente Daly City

Daly City, California, United States

Site Status

Premier Health Research Center, LLC

Downey, California, United States

Site Status

Paradigm Clinical Research Centers, Inc.

La Mesa, California, United States

Site Status

VA Loma Linda Healthcare System Research Pharmacy

Loma Linda, California, United States

Site Status

VA Loma Linda Healthcare System

Loma Linda, California, United States

Site Status

Long Beach Clinical Trials Services, Inc.

Long Beach, California, United States

Site Status

Long Beach Clinical Trials

Long Beach, California, United States

Site Status

VA Long Beach Healthcare System

Long Beach, California, United States

Site Status

Academic Medical Research Institute

Los Angeles, California, United States

Site Status

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

UCLA CTRC Outpatient Unit

Los Angeles, California, United States

Site Status

VA Northern California Health Care System

Mather, California, United States

Site Status

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Covigilant Research, LLC

Rancho Mirage, California, United States

Site Status

Paradigm Clinical Research Centers, Inc.

Redding, California, United States

Site Status

VA Loma Linda Healthcare System Ambulatory Care System

Redlands, California, United States

Site Status

Covigilant Research LLC

Riverside, California, United States

Site Status

Kaiser Permanente Roseville

Roseville, California, United States

Site Status

One Community Health

Sacramento, California, United States

Site Status

Kaiser Permanente Sacramento

Sacramento, California, United States

Site Status

CTSC Clinical Research Center

Sacramento, California, United States

Site Status

Lawrence J. Ellison Ambulatory Care Center

Sacramento, California, United States

Site Status

University of California, Davis Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente South Sacramento

Sacramento, California, United States

Site Status

Breakthrough Clinical Trials

San Bernardino, California, United States

Site Status

VA San Diego Healthcare System

San Diego, California, United States

Site Status

California Kidney Specialists

San Dimas, California, United States

Site Status

Kaiser Permanente San Jose

San Jose, California, United States

Site Status

Kaiser Permanente Santa Clara

Santa Clara, California, United States

Site Status

Alta California Medical Group

Simi Valley, California, United States

Site Status

Kaiser Permanente Walnut Creek

Walnut Creek, California, United States

Site Status

Clinical Trial Center University of Colorado Denver, School of Medicine

Aurora, Colorado, United States

Site Status

University of Colorado Clinical & Translational Research Center Clinic

Aurora, Colorado, United States

Site Status

University of Colorado Clinical & Translational Research Center Outpatient Clinic

Aurora, Colorado, United States

Site Status

University of Colorado Denver, School of Medicine

Aurora, Colorado, United States

Site Status

University of Colorado Department of AIP 2. Pharmacy Bulk Storage

Aurora, Colorado, United States

Site Status

Gastroenterology Center of Connecticut, PC

Hamden, Connecticut, United States

Site Status

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Site Status

Clinical Research Consulting, LLC

Milford, Connecticut, United States

Site Status

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Site Status

Florida Sleep Disorder Center of Brandon

Brandon, Florida, United States

Site Status

Teradan Clinical Trials

Brandon, Florida, United States

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Southeast Clinical Research

Chiefland, Florida, United States

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Innovative Research of West FL., Inc.

Clearwater, Florida, United States

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Alliance for Multispecialty Reseach, LLC

Coral Gables, Florida, United States

Site Status

Omega Research Consultants, LLC

DeBary, Florida, United States

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Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States

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Fleming Island Center for Clinical Research

Fleming Island, Florida, United States

Site Status

Malcom Randall VA Medical Center Investigational Drug Services

Gainesville, Florida, United States

Site Status

Malcom Randall VA Medical Center

Gainesville, Florida, United States

Site Status

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status

Clinical Neuroscience Solutions,Inc.

Jacksonville, Florida, United States

Site Status

Multi-Specialty Research Associates, Inc.

Lake City, Florida, United States

Site Status

Optimus U. Corp.

Miami, Florida, United States

Site Status

Finlay Medical Research

Miami, Florida, United States

Site Status

Doctors Research Institute

Miami, Florida, United States

Site Status

Acevedo Clinical Research Associates

Miami, Florida, United States

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Next Phase Research Alliance

Miami, Florida, United States

Site Status

Charisma Medical and Research Center

Miami Lakes, Florida, United States

Site Status

Ocean Blue Medical Research Center, Inc.

Miami Springs, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Orlando, Florida, United States

Site Status

HMD Research LLC

Orlando, Florida, United States

Site Status

Pines Care Research Center, LLC

Pembroke Pines, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Precision Clinical Research, LLC

Sunrise, Florida, United States

Site Status

Soma Medical Center

West Palm Beach, Florida, United States

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Atlanta VA Medical Center

Decatur, Georgia, United States

Site Status

Meridian Clinical Research

Savannah, Georgia, United States

Site Status

Clinical Research Atlanta

Stockbridge, Georgia, United States

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East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Snake River Research, PLLC

Idaho Falls, Idaho, United States

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Advanced Clinical Research

Meridian, Idaho, United States

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Solaris Clinical Research

Meridian, Idaho, United States

Site Status

Christie Clinic, LLC

Champaign, Illinois, United States

Site Status

Edward Hines Jr VA Hospital

Hines, Illinois, United States

Site Status

Springfield Clinic Infectious Diseases

Springfield, Illinois, United States

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Community Clinical Research Center

Anderson, Indiana, United States

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Infectious Disease of Indiana, PSC

Carmel, Indiana, United States

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St. Vincent Outpatient Treatment Center

Carmel, Indiana, United States

Site Status

Deaconess Clinic Mt. Pleasant

Evansville, Indiana, United States

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St. Vincent Hospital & Health Care Center

Indianapolis, Indiana, United States

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St. Vincent Hospital and Health Care Center

Indianapolis, Indiana, United States

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MOC Research

Mishawaka, Indiana, United States

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Meridian Clinical Research

Sioux City, Iowa, United States

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Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States

Site Status

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, United States

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Central Kentucky Research Associates, LLC

Lexington, Kentucky, United States

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Tandem Clinical Research, LLC

Marrero, Louisiana, United States

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MedPharmics, LLC

Metairie, Louisiana, United States

Site Status

Barnum Medical Research Inc

Natchitoches, Louisiana, United States

Site Status

Ochsner Center for Primary Care and Wellness

New Orleans, Louisiana, United States

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Ochsner Clinic Foundation

New Orleans, Louisiana, United States

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Luminis Health Anne Arundel Medical Center Infusion Center

Annapolis, Maryland, United States

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Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, United States

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Luminis Health Research Institute: Research Office

Annapolis, Maryland, United States

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VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

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ClinSite, LLC

Canton, Michigan, United States

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Aa Mrc Llc

Flint, Michigan, United States

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Revival Research Institute, LLC

Sterling Heights, Michigan, United States

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Mayo Clinic Rochester, Methodist Hospital Campus

Rochester, Minnesota, United States

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Mayo Clinic

Rochester, Minnesota, United States

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MedPharmics

Gulfport, Mississippi, United States

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Center for Outpatient Health

St Louis, Missouri, United States

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Washington University School of Medicine

St Louis, Missouri, United States

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Barnes Jewish Hospital

St Louis, Missouri, United States

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Barnes-Jewish Hospital

St Louis, Missouri, United States

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Center for Advanced Medicine

St Louis, Missouri, United States

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Center For Clinical Studies

St Louis, Missouri, United States

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Sundance Clinical Research

St Louis, Missouri, United States

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Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research

Bozeman, Montana, United States

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Bozeman Health GI Clinic

Bozeman, Montana, United States

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Mercury Street Medical Group, PLLC

Butte, Montana, United States

Site Status

Meridian Clinical Research, LLC

Norfolk, Nebraska, United States

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Barrett Clinic

Omaha, Nebraska, United States

Site Status

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

Site Status

ID Care

Hillsborough, New Jersey, United States

Site Status

Amici Clinical Research

Raritan, New Jersey, United States

Site Status

South Jersey Infectious Disease

Somers Point, New Jersey, United States

Site Status

New Mexico VA Healthcare System

Albuquerque, New Mexico, United States

Site Status

Meridian Clinical Research LLC

Binghamton, New York, United States

Site Status

Meridian Clinical Research, LLC

Endwell, New York, United States

Site Status

Rochester Clinical Research

Rochester, New York, United States

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PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

Cary, North Carolina, United States

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PMG Research of Charlotte, LLC

Charlotte, North Carolina, United States

Site Status

Durham VAMC

Durham, North Carolina, United States

Site Status

Duke Early Phase Clinical Research

Durham, North Carolina, United States

Site Status

Duke University Hospital Investigational Drug Services (IDS) Pharmacy

Durham, North Carolina, United States

Site Status

PharmQuest

Greensboro, North Carolina, United States

Site Status

PMG Research of Hickory, LLC

Hickory, North Carolina, United States

Site Status

PMG Research of Raleigh, LLC

Raleigh, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

PMG Research of Rocky Mount, LLC

Rocky Mount, North Carolina, United States

Site Status

PMG Research of Salisbury, LLC

Salisbury, North Carolina, United States

Site Status

Waterway Primary Care LLC DBA Tabor City Family Medicine

Tabor City, North Carolina, United States

Site Status

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Site Status

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

Site Status

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, United States

Site Status

Lillestol Research LLC

Fargo, North Dakota, United States

Site Status

Aultman Cardiology Clinical Trials

Canton, Ohio, United States

Site Status

Aultman Hospital

Canton, Ohio, United States

Site Status

UC Health Physicians Office Clifton

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Sterling Research Group, Ltd.

Cincinnati, Ohio, United States

Site Status

University Of Cincinnati-Internal Medicine Division of Digestive Diseases

Cincinnati, Ohio, United States

Site Status

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Velocity Clinical Research, Inc.

Cleveland, Ohio, United States

Site Status

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Remington-Davis, Incorporated

Columbus, Ohio, United States

Site Status

PriMED Clinical Research

Dayton, Ohio, United States

Site Status

Great Lakes Medical Research LLC

Mentor, Ohio, United States

Site Status

IPS Research Company

Oklahoma City, Oklahoma, United States

Site Status

Kaiser Permanente Center For Health Research

Portland, Oregon, United States

Site Status

Columbia Research Group, Inc.

Portland, Oregon, United States

Site Status

VA Portland Healthcare System

Portland, Oregon, United States

Site Status

Lehigh Valley Health Network/Network Office of Research and Innovation

Allentown, Pennsylvania, United States

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Capital Area Research, LLC

Camp Hill, Pennsylvania, United States

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Westminster Family Medicine

Erie, Pennsylvania, United States

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Liberty Family Practice

Erie, Pennsylvania, United States

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Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

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VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

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Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians, Inc.

Uniontown, Pennsylvania, United States

Site Status

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, United States

Site Status

Medical Research South, LLC

Charleston, South Carolina, United States

Site Status

Main Street Physician's Care - Waterway

Little River, South Carolina, United States

Site Status

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Site Status

Holston Medical Group

Bristol, Tennessee, United States

Site Status

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, United States

Site Status

PMG Research of Bristol, LLC

Bristol, Tennessee, United States

Site Status

PMG Research, Inc. d/b/a PMG Research of Knoxville

Knoxville, Tennessee, United States

Site Status

PMG Research,Inc. d/b/a PMG Research of Knoxville

Knoxville, Tennessee, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Site Status

Trinity Clinical Research

Tullahoma, Tennessee, United States

Site Status

Tekton Research, Inc.

Austin, Texas, United States

Site Status

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas, United States

Site Status

Synexus US, LP

Dallas, Texas, United States

Site Status

Texas Health Care, PLLC

Fort Worth, Texas, United States

Site Status

Ventavia Research Group, LLC

Fort Worth, Texas, United States

Site Status

University of North Texas Health Science Center at Fort Worth

Fort Worth, Texas, United States

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University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Kelsey Research Foundation

Houston, Texas, United States

Site Status

Kelsey-Seybold Clinic

Houston, Texas, United States

Site Status

Texas Center for Drug Development, Inc.

Houston, Texas, United States

Site Status

Synexus US, dba Research Across America

Mesquite, Texas, United States

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LinQ Research, LLC

Pearland, Texas, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

Diagnostics Research Group

San Antonio, Texas, United States

Site Status

South Texas Veterans Healthcare System, Audie L Murphy Hospital

San Antonio, Texas, United States

Site Status

DM Clinical Research

Tomball, Texas, United States

Site Status

Martin Diagnostic Clinic

Tomball, Texas, United States

Site Status

J. Lewis Research Inc. / Foothill Family Clinic Draper

Draper, Utah, United States

Site Status

Advanced Clinical Research/Gut Whisperer

Riverton, Utah, United States

Site Status

J. Lewis Research, Inc./Foothill Family Clinic

Salt Lake City, Utah, United States

Site Status

J Lewis Research, Incorporated

Salt Lake City, Utah, United States

Site Status

J. Lewis Research, Inc. - Jordan River Family Medicine

South Jordan, Utah, United States

Site Status

Clinical Alliance for Research & Education - Infectious Diseases, LLC

Annandale, Virginia, United States

Site Status

Virginia Research Center LLC

Midlothian, Virginia, United States

Site Status

Salem VAMC

Salem, Virginia, United States

Site Status

Frandsen Family Medicine DBA Sound Medical Research

Port Orchard, Washington, United States

Site Status

MultiCare Institute for Research & Innovation

Tacoma, Washington, United States

Site Status

Universal Research Group, LLC

Tacoma, Washington, United States

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Wenatchee Valley Hospital & Clinics

Wenatchee, Washington, United States

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Marshfield Medical Center - Marshfield

Marshfield, Wisconsin, United States

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Hospital Aleman

C.a.b.a., Buenos Aires, Argentina

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Hospital Italiano de Buenos Aires

C.a.b.a., Buenos Aires, Argentina

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Centro Médico Dra. De Salvo

C.a.b.a., Buenos Aires, Argentina

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Sanatorio Británico S.A.

Rosario, Santa Fe Province, Argentina

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Hospital Nuestra Senora de la Misericordia

Córdoba, , Argentina

Site Status

Paratus Clinical Pty Ltd

Kanwal, New South Wales, Australia

Site Status

Australian Clinical Research Network

Maroiubra, New South Wales, Australia

Site Status

Maroubra Medical Centre

Maroubra, New South Wales, Australia

Site Status

University Clinic Pharmacy

Westmead, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Austrials Pty Ltd

Sherwood, Queensland, Australia

Site Status

Mater Misericordiae Ltd & Mater Medical Research Institute Ltd

South Brisbane, Queensland, Australia

Site Status

Eastern Health - Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

Emeritus Research

Camberwell, Victoria, Australia

Site Status

Barwon Health

Geelong, Victoria, Australia

Site Status

Linear Clinical Research

Nedlands, Western Australia, Australia

Site Status

Australian Clinical Research Network

Maroubra, , Australia

Site Status

Institut Jules Bordet

Brussels, , Belgium

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UZ Leuven

Leuven, , Belgium

Site Status

CHU de Liège - Domaine universitaire du Sart Tilman

Liège, , Belgium

Site Status

"MHAT- Dr. Hristo Stambolski" EOOD

Kazanlak, , Bulgaria

Site Status

MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department

Kozloduy, , Bulgaria

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MHAT "Sv. Nikolay Chudotvorets" EOOD

Lom, , Bulgaria

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UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence

Pleven, , Bulgaria

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UMHAT "Sveti Georgi" EAD

Plovdiv, , Bulgaria

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"Center for Mental Health - Ruse" EOOD

Rousse, , Bulgaria

Site Status

SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD

Rousse, , Bulgaria

Site Status

''Medical Center-1-Sevlievo'' EOOD

Sevlievo, , Bulgaria

Site Status

MHAT -Silistra AD

Silistra, , Bulgaria

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MC ''Tsaritsa Yoanna''EOOD

Sliven, , Bulgaria

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MC 'Cardiohelp' EOOD

Sofia, , Bulgaria

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"Acibadem City Clinic University Hospital" EOOD

Sofia, , Bulgaria

Site Status

Acibadem City Clinic Tokuda Ead

Sofia, , Bulgaria

Site Status

MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases

Sofia, , Bulgaria

Site Status

"SHATPD-Troyan" EOOD

Troyan Municipality, , Bulgaria

Site Status

MC Medica Plus OOD

Veliko Tarnovo, , Bulgaria

Site Status

MHAT ''Sveta Petka" AD

Vidin, , Bulgaria

Site Status

Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre

Vancouver, British Columbia, Canada

Site Status

The Ottawa Hospital General Campus

Ottawa, Ontario, Canada

Site Status

The Ottawa Hospital Civic Campus

Ottawa, Ontario, Canada

Site Status

Manna Research Inc. (Toronto)

Toronto, Ontario, Canada

Site Status

Intermed Groupe Santé

Chicoutimi, Quebec, Canada

Site Status

Q & T Research Outaouais Inc.

Gatineau, Quebec, Canada

Site Status

Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne

Greenfield Park, Quebec, Canada

Site Status

Centre de recherche du CHU de Quebec-Universite Laval

Québec, Quebec, Canada

Site Status

Centre de recherche Saint-Louis

Québec, Quebec, Canada

Site Status

ALPHA Recherche Clinique

Québec, Quebec, Canada

Site Status

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, Canada

Site Status

Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec

Trois-Rivières, Quebec, Canada

Site Status

Psicomed Esudios Medicos

Antofagasta, Antofagasta, Chile

Site Status

Centro de Investigacion Clínica del Sur

Temuco, IX Region de LA Araucania, Chile

Site Status

Hospital Dr. Hernan Henriquez Aravena

Temuco, Región de la Araucanía, Chile

Site Status

Biomedica Research Group

Santiago, Santiago Metropolitan, Chile

Site Status

Fundacion Arriaran

Santiago, Santiago Metropolitan, Chile

Site Status

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Site Status

Fundacion Centro de Investigacion Clinica - CIC

Medellín, Antioquia, Colombia

Site Status

Instituto de Coloproctologia ICO

Medellín, Antioquia, Colombia

Site Status

Clinica de la Costa Ltda.

Barranquilla, Atlántico, Colombia

Site Status

Asociación IPS Médicos Internistas de Caldas

Manizales, Caldas Department, Colombia

Site Status

Centro de Investigaciones - MedPlus Centro de Recuperación Integral S.A.S.

Bogotá, D.C., Colombia

Site Status

Fundación Cardiomet CEQUIN

Armenia, Quindío Department, Colombia

Site Status

Fundacion Cardiovascular de Colombia

Floridablanca, Santander Department, Colombia

Site Status

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Site Status

Centro Medico Imbanaco de Cali S.A.

Cali, Valle del Cauca Department, Colombia

Site Status

Doktor Brno s.r.o.

Brno, Czech, Czechia

Site Status

Ordinace vseobecneho praktickeho lekare

Benátky nad Jizerou, , Czechia

Site Status

Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni

Kyjov, , Czechia

Site Status

Slezska Nemocnice v Opave, prispevkova organizace

Opava, , Czechia

Site Status

Policska nemocnice s.r.o.,

Polička, , Czechia

Site Status

Fakultni nemocnice v Motole

Prague, , Czechia

Site Status

Oblastni nemocnice Pribram, a.s.

Pribram I., , Czechia

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Interna a kardiologie s.r.o.

Rožnov pod Radhoštěm, , Czechia

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Nemocnice Slany, p.o.

Slaný, , Czechia

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Sarkamed s.r.o.

Slaný, , Czechia

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Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem

Ústí nad Labem, , Czechia

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Helsinki University Central Hospital

Helsinki, , Finland

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Kokkola Vaccine Research Clinic

Kokkola, , Finland

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Oulu Vaccine Research Clinic

Oulu, , Finland

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Pori Vaccine Research Clinic

Pori, , Finland

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Tampere Vaccine Research Clinic

Tampere, , Finland

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Turku Vaccine Research Clinic

Turku, , Finland

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CHU DIJON BOURGOGNE- Hopital Francois Mitterrand

Dijon, , France

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CIC Vaccinologie Cochin- Pasteur 1417

Paris, , France

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Hopital Nord-CHU Saint Etienne

Saint-Priest-en-Jarez, , France

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CHRU de Tours- Hopital Bretonneau

Tours, , France

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Emovis GmbH

Berlin, , Germany

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MECS Cottbus GmbH

Cottbus, , Germany

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Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann

Dresden, , Germany

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Universitaetsklinikum Essen, Klinik fuer Infektiologie

Essen, , Germany

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EUGASTRO GmbH/ Praxis

Leipzig, , Germany

Site Status

SIBAmed Studienzentrum GmbH & Co.KG

Leipzig, , Germany

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Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut

Leipzig, , Germany

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Universitaetsmedizin Rostock

Rostock, , Germany

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Praxis Dr. med. J. Springub/ W. Schwarz

Westerstede, , Germany

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Studienzentrum Nordwest

Westerstede, , Germany

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Klinikum Wuerzburg Mitte gGmbH

Würzburg, , Germany

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Bajai Szent Rokus Korhaz, II Belgyogyaszat

Baja, , Hungary

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DRC Kft.

Balatonfüred, , Hungary

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Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly

Budapest, , Hungary

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Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly

Budapest, , Hungary

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Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly

Budapest, , Hungary

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Semmelweis Egyetem III. Sz. Belgyogyaszati Klinika

Budapest, , Hungary

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ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia

Debrecen, , Hungary

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CRU Hungary Kft.

Encs, , Hungary

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Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly

Kaposvár, , Hungary

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Tokai Memorial Hospital

Kasugai, Aichi-ken, Japan

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Aichi Medical University Hospital

Nagakute, Aichi-ken, Japan

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Daido Clinic

Nagoya, Aichi-ken, Japan

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Kamiiida daiichi General Hospital

Nagoya, Aichi-ken, Japan

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Iizuka Hospital

Iizuka, Fukuoka, Japan

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Seishinkai Inoue Hospital

Itoshima, Fukuoka, Japan

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Fukuoka Tokushukai Hospital

Kasuga, Fukuoka, Japan

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Kenwakai Otemachi Hospital

Kitakyushu, Fukuoka, Japan

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Fukuyama City Hospital

Fukuyama, Hiroshima, Japan

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Miyanomori Memorial Hospital

Sapporo, Hokkaido, Japan

Site Status

Medical Corporation Tokushukai Koga General Hospital

Koga, Ibaraki, Japan

Site Status

Mito Kyodo General Hospital

Mito, Ibaraki, Japan

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Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, Japan

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Osaki Citizen Hospital

Ōsaki, Miyagi, Japan

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Social Medical Care Corporation Hose-kai Marunouchi Hospital

Matsumoto, Nagano, Japan

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Nozaki Tokushukai Hospital

Daitō, Osaka, Japan

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Omi Medical Center

Kusatsu, Shiga, Japan

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Yaizu City Hospital

Yaizu, Shizuoka, Japan

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Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

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Fukuwa Clinic

Chuo-ku, Tokyo, Japan

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Nerima General Hospital

Nerima-ku, Tokyo, Japan

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Sekino Hospital

Toshima-ku, Tokyo, Japan

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Fukui-Ken Saiseikai Hospital

Fukui, , Japan

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Japanese Red Cross Kumamoto Hospital

Kumamoto, , Japan

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Saga-Ken Medical Centre Koseikan

Saga, , Japan

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Hospital Cayetano Heredia

San Martín de Porres, Lima region, Peru

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Hospital Nacional Adolfo Guevara Velasco

Cusco, , Peru

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Clinica Internacional S.A

Lima, , Peru

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Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A

Trujillo, La Libertad, , Peru

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NZOZ Vitamed

Bydgoszcz, , Poland

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Synexus Polska Sp. z o.o Oddzial w Gdansku

Gdansk, , Poland

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Synexus Polska Sp. z o.o. Oddzial w Gdyni

Gdynia, , Poland

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SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach

Katowice, , Poland

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Synexus Polska Sp. z o.o. Oddział w Poznaniu

Poznan, , Poland

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Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, , Poland

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Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, , Poland

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Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.

Łęczna, , Poland

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Hospital Garcia de Orta

Almada, , Portugal

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Centro Hospitalar do Baixo Vouga, E.P.E.

Aveiro, , Portugal

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Hospital de Braga

Braga, , Portugal

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Hospital Senhora de Oliveira - Guimaraes, E.P.E.

Guimarães, , Portugal

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Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.

Vila Nova de Gaia, , Portugal

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PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia

Bojnice, , Slovakia

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Medak s.r.o., Gastroenterologicka ambulancia

Bratislava, , Slovakia

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Stalerg, s.r.o.

Košice, , Slovakia

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KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

Nitra, , Slovakia

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Dionea, s.r.o.

Nové Zámky, , Slovakia

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MEDIPA, s.r.o.

Piešťany, , Slovakia

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MUDr. Viliam Cibik, PhD, s.r.o.

Pruské, , Slovakia

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Medilex s.r.o., Interna ambulancia

Rimavská Sobota, , Slovakia

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Plucna ambulancia Hrebenar s.r.o.

Spišská Nová Ves, , Slovakia

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SPAOLO s.r.o., Ambulancia vnutorneho lekarstva

Stará Turá, , Slovakia

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Privatna urologicka ambulancia, s.r.o.

Trenčín, , Slovakia

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MUDr. Zakova, s.r.o.

Trenčín, , Slovakia

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Fakutna nemocnica Trnava

Trnava, , Slovakia

Site Status

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Site Status

Asan Medical Center

Songpa-gu, Seoul, South Korea

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Dong-A University Hospital

Busan, , South Korea

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Kyungpook National University Hospital

Daegu, , South Korea

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The Catholic University of Korea, St. Vincent's Hospital

Gyeonggi-do, , South Korea

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Gachon University Gil Medical Center

Incheon, , South Korea

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Inha University Hospital

Incheon, , South Korea

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Korea University Anam Hospital

Seoul, , South Korea

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Hallym University Kangdong Sacred Heart Hospital

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

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Korea University Guro Hospital

Seoul, , South Korea

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EAP Centelles

Centelles, Barcelona, Spain

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Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

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Complejo Hospitalario Universitario A Coruna

A Coruña, , Spain

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Parc de Salut Mar- Hospital del Mar

Barcelona, , Spain

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Hospital Clinic de Barcelona

Barcelona, , Spain

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

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Hospital Universitario de la Princesa

Madrid, , Spain

Site Status

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

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Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status

Infektionskliniken, Malarsjukhuset

Eskilstuna, , Sweden

Site Status

Gothia Forum CTC/Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset

Gothenburg, , Sweden

Site Status

Avdelningen for kliniska provningar, S-huset

Örebro, , Sweden

Site Status

Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus

Stockholm, , Sweden

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan (r.o.c.), Taiwan

Site Status

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Stockport Nhs Foundation Trust

Stockport, Cheshire, United Kingdom

Site Status

Fowey River Practice

Fowey, Cornwall, United Kingdom

Site Status

Oak Tree Surgery

Liskeard, Cornwall, United Kingdom

Site Status

The Alverton Practise, St Clare Medical Centre

Penzance, Cornwall, United Kingdom

Site Status

Rame Group Practice, Rame Medical Ltd.

Torpoint, Cornwall, United Kingdom

Site Status

Royal Devon & Exeter Hospital

Exeter, Devon, United Kingdom

Site Status

Knowle House Surgery

Plymouth, Devon, United Kingdom

Site Status

Layton Medical Centre

Blackpool, Lancashire, United Kingdom

Site Status

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom

Site Status

NHS Lothian, Western General Hospital

Edinburgh, Midlothian, United Kingdom

Site Status

Heart of England NHS Foundation Trust

Birmingham, WEST Midlands, United Kingdom

Site Status

St James University Hospital

Leeds, , United Kingdom

Site Status

Newcastle upon Tyne Hospitals NHS Foundation trust

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Bulgaria Canada Chile Colombia Czechia Finland France Germany Hungary Japan Peru Poland Portugal Slovakia South Korea Spain Sweden Taiwan United Kingdom

References

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Donskey CJ, Dubberke ER, Klein NP, Liles EG, Szymkowiak K, Wilcox MH, Lawrence J, Bouguermouh S, Zhang H, Koury K, Bailey R, Smith HM, Lockhart S, Lamberth E, Kalina WV, Pride MW, Webber C, Anderson AS, Jansen KU, Gruber WC, Kitchin N. CLOVER (CLOstridium difficile Vaccine Efficacy tRial) Study: A Phase 3, Randomized Trial Investigating the Efficacy and Safety of a Detoxified Toxin A/B Vaccine in Adults 50 Years and Older at Increased Risk of Clostridioides difficile Infection. Clin Infect Dis. 2024 Dec 17;79(6):1503-1511. doi: 10.1093/cid/ciae410.

Reference Type DERIVED
PMID: 39180325 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B5091007

To obtain contact information for a study center near you, click here.

Other Identifiers

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2016-003866-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLOVER

Identifier Type: OTHER

Identifier Source: secondary_id

B5091007

Identifier Type: -

Identifier Source: org_study_id

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