Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
17535 participants
INTERVENTIONAL
2017-03-29
2021-12-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Clostridium difficile vaccine
Clostridium difficile vaccine
Toxoid-based Clostridium difficile vaccine
Placebo
Placebo
Normal saline solution (0.9% sodium chloride)
Interventions
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Clostridium difficile vaccine
Toxoid-based Clostridium difficile vaccine
Placebo
Normal saline solution (0.9% sodium chloride)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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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
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Coastal Clinical Research, LLC, An AMR Company
Mobile, Alabama, United States
The Pain Center of Arizona
Peoria, Arizona, United States
Phoenix VA Health Care System
Phoenix, Arizona, United States
Phoenix Clinical LLC
Phoenix, Arizona, United States
MedPharmics, LLC
Phoenix, Arizona, United States
Hope Research Institute
Phoenix, Arizona, United States
The Pain Center of Arizona
Phoenix, Arizona, United States
Clinical Research Institute of Arizona, LLC
Surprise, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Baptist Health Rehabilitation Institute
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
California Kidney Specialist
Covina, California, United States
Usborne Family Medicine
Covina, California, United States
Kaiser Permanente Daly City
Daly City, California, United States
Premier Health Research Center, LLC
Downey, California, United States
Paradigm Clinical Research Centers, Inc.
La Mesa, California, United States
VA Loma Linda Healthcare System Research Pharmacy
Loma Linda, California, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
Long Beach Clinical Trials Services, Inc.
Long Beach, California, United States
Long Beach Clinical Trials
Long Beach, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA CTRC Outpatient Unit
Los Angeles, California, United States
VA Northern California Health Care System
Mather, California, United States
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States
Covigilant Research, LLC
Rancho Mirage, California, United States
Paradigm Clinical Research Centers, Inc.
Redding, California, United States
VA Loma Linda Healthcare System Ambulatory Care System
Redlands, California, United States
Covigilant Research LLC
Riverside, California, United States
Kaiser Permanente Roseville
Roseville, California, United States
One Community Health
Sacramento, California, United States
Kaiser Permanente Sacramento
Sacramento, California, United States
CTSC Clinical Research Center
Sacramento, California, United States
Lawrence J. Ellison Ambulatory Care Center
Sacramento, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Kaiser Permanente South Sacramento
Sacramento, California, United States
Breakthrough Clinical Trials
San Bernardino, California, United States
VA San Diego Healthcare System
San Diego, California, United States
California Kidney Specialists
San Dimas, California, United States
Kaiser Permanente San Jose
San Jose, California, United States
Kaiser Permanente Santa Clara
Santa Clara, California, United States
Alta California Medical Group
Simi Valley, California, United States
Kaiser Permanente Walnut Creek
Walnut Creek, California, United States
Clinical Trial Center University of Colorado Denver, School of Medicine
Aurora, Colorado, United States
University of Colorado Clinical & Translational Research Center Clinic
Aurora, Colorado, United States
University of Colorado Clinical & Translational Research Center Outpatient Clinic
Aurora, Colorado, United States
University of Colorado Denver, School of Medicine
Aurora, Colorado, United States
University of Colorado Department of AIP 2. Pharmacy Bulk Storage
Aurora, Colorado, United States
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Clinical Research Consulting, LLC
Milford, Connecticut, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Florida Sleep Disorder Center of Brandon
Brandon, Florida, United States
Teradan Clinical Trials
Brandon, Florida, United States
Southeast Clinical Research
Chiefland, Florida, United States
Innovative Research of West FL., Inc.
Clearwater, Florida, United States
Alliance for Multispecialty Reseach, LLC
Coral Gables, Florida, United States
Omega Research Consultants, LLC
DeBary, Florida, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
Malcom Randall VA Medical Center Investigational Drug Services
Gainesville, Florida, United States
Malcom Randall VA Medical Center
Gainesville, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Clinical Neuroscience Solutions,Inc.
Jacksonville, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Optimus U. Corp.
Miami, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Doctors Research Institute
Miami, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Next Phase Research Alliance
Miami, Florida, United States
Charisma Medical and Research Center
Miami Lakes, Florida, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Orlando, Florida, United States
HMD Research LLC
Orlando, Florida, United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Precision Clinical Research, LLC
Sunrise, Florida, United States
Soma Medical Center
West Palm Beach, Florida, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Snake River Research, PLLC
Idaho Falls, Idaho, United States
Advanced Clinical Research
Meridian, Idaho, United States
Solaris Clinical Research
Meridian, Idaho, United States
Christie Clinic, LLC
Champaign, Illinois, United States
Edward Hines Jr VA Hospital
Hines, Illinois, United States
Springfield Clinic Infectious Diseases
Springfield, Illinois, United States
Community Clinical Research Center
Anderson, Indiana, United States
Infectious Disease of Indiana, PSC
Carmel, Indiana, United States
St. Vincent Outpatient Treatment Center
Carmel, Indiana, United States
Deaconess Clinic Mt. Pleasant
Evansville, Indiana, United States
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
MOC Research
Mishawaka, Indiana, United States
Meridian Clinical Research
Sioux City, Iowa, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Central Kentucky Research Associates, LLC
Lexington, Kentucky, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, United States
MedPharmics, LLC
Metairie, Louisiana, United States
Barnum Medical Research Inc
Natchitoches, Louisiana, United States
Ochsner Center for Primary Care and Wellness
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Luminis Health Anne Arundel Medical Center Infusion Center
Annapolis, Maryland, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States
Luminis Health Research Institute: Research Office
Annapolis, Maryland, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
ClinSite, LLC
Canton, Michigan, United States
Aa Mrc Llc
Flint, Michigan, United States
Revival Research Institute, LLC
Sterling Heights, Michigan, United States
Mayo Clinic Rochester, Methodist Hospital Campus
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
MedPharmics
Gulfport, Mississippi, United States
Center for Outpatient Health
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Center for Advanced Medicine
St Louis, Missouri, United States
Center For Clinical Studies
St Louis, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
Bozeman, Montana, United States
Bozeman Health GI Clinic
Bozeman, Montana, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Barrett Clinic
Omaha, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
ID Care
Hillsborough, New Jersey, United States
Amici Clinical Research
Raritan, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
New Mexico VA Healthcare System
Albuquerque, New Mexico, United States
Meridian Clinical Research LLC
Binghamton, New York, United States
Meridian Clinical Research, LLC
Endwell, New York, United States
Rochester Clinical Research
Rochester, New York, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
Durham VAMC
Durham, North Carolina, United States
Duke Early Phase Clinical Research
Durham, North Carolina, United States
Duke University Hospital Investigational Drug Services (IDS) Pharmacy
Durham, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States
Waterway Primary Care LLC DBA Tabor City Family Medicine
Tabor City, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Aultman Cardiology Clinical Trials
Canton, Ohio, United States
Aultman Hospital
Canton, Ohio, United States
UC Health Physicians Office Clifton
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
University Of Cincinnati-Internal Medicine Division of Digestive Diseases
Cincinnati, Ohio, United States
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Velocity Clinical Research, Inc.
Cleveland, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Remington-Davis, Incorporated
Columbus, Ohio, United States
PriMED Clinical Research
Dayton, Ohio, United States
Great Lakes Medical Research LLC
Mentor, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Kaiser Permanente Center For Health Research
Portland, Oregon, United States
Columbia Research Group, Inc.
Portland, Oregon, United States
VA Portland Healthcare System
Portland, Oregon, United States
Lehigh Valley Health Network/Network Office of Research and Innovation
Allentown, Pennsylvania, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Westminster Family Medicine
Erie, Pennsylvania, United States
Liberty Family Practice
Erie, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Medical Research South, LLC
Charleston, South Carolina, United States
Main Street Physician's Care - Waterway
Little River, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Holston Medical Group
Bristol, Tennessee, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, United States
PMG Research, Inc. d/b/a PMG Research of Knoxville
Knoxville, Tennessee, United States
PMG Research,Inc. d/b/a PMG Research of Knoxville
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Trinity Clinical Research
Tullahoma, Tennessee, United States
Tekton Research, Inc.
Austin, Texas, United States
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, United States
Synexus US, LP
Dallas, Texas, United States
Texas Health Care, PLLC
Fort Worth, Texas, United States
Ventavia Research Group, LLC
Fort Worth, Texas, United States
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Kelsey Research Foundation
Houston, Texas, United States
Kelsey-Seybold Clinic
Houston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Synexus US, dba Research Across America
Mesquite, Texas, United States
LinQ Research, LLC
Pearland, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
South Texas Veterans Healthcare System, Audie L Murphy Hospital
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, United States
Advanced Clinical Research/Gut Whisperer
Riverton, Utah, United States
J. Lewis Research, Inc./Foothill Family Clinic
Salt Lake City, Utah, United States
J Lewis Research, Incorporated
Salt Lake City, Utah, United States
J. Lewis Research, Inc. - Jordan River Family Medicine
South Jordan, Utah, United States
Clinical Alliance for Research & Education - Infectious Diseases, LLC
Annandale, Virginia, United States
Virginia Research Center LLC
Midlothian, Virginia, United States
Salem VAMC
Salem, Virginia, United States
Frandsen Family Medicine DBA Sound Medical Research
Port Orchard, Washington, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
Universal Research Group, LLC
Tacoma, Washington, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States
Marshfield Medical Center - Marshfield
Marshfield, Wisconsin, United States
Hospital Aleman
C.a.b.a., Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
C.a.b.a., Buenos Aires, Argentina
Centro Médico Dra. De Salvo
C.a.b.a., Buenos Aires, Argentina
Sanatorio Británico S.A.
Rosario, Santa Fe Province, Argentina
Hospital Nuestra Senora de la Misericordia
Córdoba, , Argentina
Paratus Clinical Pty Ltd
Kanwal, New South Wales, Australia
Australian Clinical Research Network
Maroiubra, New South Wales, Australia
Maroubra Medical Centre
Maroubra, New South Wales, Australia
University Clinic Pharmacy
Westmead, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Austrials Pty Ltd
Sherwood, Queensland, Australia
Mater Misericordiae Ltd & Mater Medical Research Institute Ltd
South Brisbane, Queensland, Australia
Eastern Health - Box Hill Hospital
Box Hill, Victoria, Australia
Emeritus Research
Camberwell, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Australian Clinical Research Network
Maroubra, , Australia
Institut Jules Bordet
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
CHU de Liège - Domaine universitaire du Sart Tilman
Liège, , Belgium
"MHAT- Dr. Hristo Stambolski" EOOD
Kazanlak, , Bulgaria
MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department
Kozloduy, , Bulgaria
MHAT "Sv. Nikolay Chudotvorets" EOOD
Lom, , Bulgaria
UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence
Pleven, , Bulgaria
UMHAT "Sveti Georgi" EAD
Plovdiv, , Bulgaria
"Center for Mental Health - Ruse" EOOD
Rousse, , Bulgaria
SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD
Rousse, , Bulgaria
''Medical Center-1-Sevlievo'' EOOD
Sevlievo, , Bulgaria
MHAT -Silistra AD
Silistra, , Bulgaria
MC ''Tsaritsa Yoanna''EOOD
Sliven, , Bulgaria
MC 'Cardiohelp' EOOD
Sofia, , Bulgaria
"Acibadem City Clinic University Hospital" EOOD
Sofia, , Bulgaria
Acibadem City Clinic Tokuda Ead
Sofia, , Bulgaria
MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases
Sofia, , Bulgaria
"SHATPD-Troyan" EOOD
Troyan Municipality, , Bulgaria
MC Medica Plus OOD
Veliko Tarnovo, , Bulgaria
MHAT ''Sveta Petka" AD
Vidin, , Bulgaria
Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre
Vancouver, British Columbia, Canada
The Ottawa Hospital General Campus
Ottawa, Ontario, Canada
The Ottawa Hospital Civic Campus
Ottawa, Ontario, Canada
Manna Research Inc. (Toronto)
Toronto, Ontario, Canada
Intermed Groupe Santé
Chicoutimi, Quebec, Canada
Q & T Research Outaouais Inc.
Gatineau, Quebec, Canada
Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada
Centre de recherche du CHU de Quebec-Universite Laval
Québec, Quebec, Canada
Centre de recherche Saint-Louis
Québec, Quebec, Canada
ALPHA Recherche Clinique
Québec, Quebec, Canada
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada
Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
Trois-Rivières, Quebec, Canada
Psicomed Esudios Medicos
Antofagasta, Antofagasta, Chile
Centro de Investigacion Clínica del Sur
Temuco, IX Region de LA Araucania, Chile
Hospital Dr. Hernan Henriquez Aravena
Temuco, Región de la Araucanía, Chile
Biomedica Research Group
Santiago, Santiago Metropolitan, Chile
Fundacion Arriaran
Santiago, Santiago Metropolitan, Chile
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Fundacion Centro de Investigacion Clinica - CIC
Medellín, Antioquia, Colombia
Instituto de Coloproctologia ICO
Medellín, Antioquia, Colombia
Clinica de la Costa Ltda.
Barranquilla, Atlántico, Colombia
Asociación IPS Médicos Internistas de Caldas
Manizales, Caldas Department, Colombia
Centro de Investigaciones - MedPlus Centro de Recuperación Integral S.A.S.
Bogotá, D.C., Colombia
Fundación Cardiomet CEQUIN
Armenia, Quindío Department, Colombia
Fundacion Cardiovascular de Colombia
Floridablanca, Santander Department, Colombia
Fundacion Valle del Lili
Cali, Valle del Cauca Department, Colombia
Centro Medico Imbanaco de Cali S.A.
Cali, Valle del Cauca Department, Colombia
Doktor Brno s.r.o.
Brno, Czech, Czechia
Ordinace vseobecneho praktickeho lekare
Benátky nad Jizerou, , Czechia
Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni
Kyjov, , Czechia
Slezska Nemocnice v Opave, prispevkova organizace
Opava, , Czechia
Policska nemocnice s.r.o.,
Polička, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Oblastni nemocnice Pribram, a.s.
Pribram I., , Czechia
Interna a kardiologie s.r.o.
Rožnov pod Radhoštěm, , Czechia
Nemocnice Slany, p.o.
Slaný, , Czechia
Sarkamed s.r.o.
Slaný, , Czechia
Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem
Ústí nad Labem, , Czechia
Helsinki University Central Hospital
Helsinki, , Finland
Kokkola Vaccine Research Clinic
Kokkola, , Finland
Oulu Vaccine Research Clinic
Oulu, , Finland
Pori Vaccine Research Clinic
Pori, , Finland
Tampere Vaccine Research Clinic
Tampere, , Finland
Turku Vaccine Research Clinic
Turku, , Finland
CHU DIJON BOURGOGNE- Hopital Francois Mitterrand
Dijon, , France
CIC Vaccinologie Cochin- Pasteur 1417
Paris, , France
Hopital Nord-CHU Saint Etienne
Saint-Priest-en-Jarez, , France
CHRU de Tours- Hopital Bretonneau
Tours, , France
Emovis GmbH
Berlin, , Germany
MECS Cottbus GmbH
Cottbus, , Germany
Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann
Dresden, , Germany
Universitaetsklinikum Essen, Klinik fuer Infektiologie
Essen, , Germany
EUGASTRO GmbH/ Praxis
Leipzig, , Germany
SIBAmed Studienzentrum GmbH & Co.KG
Leipzig, , Germany
Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut
Leipzig, , Germany
Universitaetsmedizin Rostock
Rostock, , Germany
Praxis Dr. med. J. Springub/ W. Schwarz
Westerstede, , Germany
Studienzentrum Nordwest
Westerstede, , Germany
Klinikum Wuerzburg Mitte gGmbH
Würzburg, , Germany
Bajai Szent Rokus Korhaz, II Belgyogyaszat
Baja, , Hungary
DRC Kft.
Balatonfüred, , Hungary
Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly
Budapest, , Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly
Budapest, , Hungary
Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly
Budapest, , Hungary
Semmelweis Egyetem III. Sz. Belgyogyaszati Klinika
Budapest, , Hungary
ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia
Debrecen, , Hungary
CRU Hungary Kft.
Encs, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly
Kaposvár, , Hungary
Tokai Memorial Hospital
Kasugai, Aichi-ken, Japan
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Daido Clinic
Nagoya, Aichi-ken, Japan
Kamiiida daiichi General Hospital
Nagoya, Aichi-ken, Japan
Iizuka Hospital
Iizuka, Fukuoka, Japan
Seishinkai Inoue Hospital
Itoshima, Fukuoka, Japan
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka, Japan
Kenwakai Otemachi Hospital
Kitakyushu, Fukuoka, Japan
Fukuyama City Hospital
Fukuyama, Hiroshima, Japan
Miyanomori Memorial Hospital
Sapporo, Hokkaido, Japan
Medical Corporation Tokushukai Koga General Hospital
Koga, Ibaraki, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, Japan
Osaki Citizen Hospital
Ōsaki, Miyagi, Japan
Social Medical Care Corporation Hose-kai Marunouchi Hospital
Matsumoto, Nagano, Japan
Nozaki Tokushukai Hospital
Daitō, Osaka, Japan
Omi Medical Center
Kusatsu, Shiga, Japan
Yaizu City Hospital
Yaizu, Shizuoka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Nerima General Hospital
Nerima-ku, Tokyo, Japan
Sekino Hospital
Toshima-ku, Tokyo, Japan
Fukui-Ken Saiseikai Hospital
Fukui, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Saga-Ken Medical Centre Koseikan
Saga, , Japan
Hospital Cayetano Heredia
San Martín de Porres, Lima region, Peru
Hospital Nacional Adolfo Guevara Velasco
Cusco, , Peru
Clinica Internacional S.A
Lima, , Peru
Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A
Trujillo, La Libertad, , Peru
NZOZ Vitamed
Bydgoszcz, , Poland
Synexus Polska Sp. z o.o Oddzial w Gdansku
Gdansk, , Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, , Poland
SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
Synexus Polska Sp. z o.o. Oddział w Poznaniu
Poznan, , Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.
Łęczna, , Poland
Hospital Garcia de Orta
Almada, , Portugal
Centro Hospitalar do Baixo Vouga, E.P.E.
Aveiro, , Portugal
Hospital de Braga
Braga, , Portugal
Hospital Senhora de Oliveira - Guimaraes, E.P.E.
Guimarães, , Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, , Portugal
PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia
Bojnice, , Slovakia
Medak s.r.o., Gastroenterologicka ambulancia
Bratislava, , Slovakia
Stalerg, s.r.o.
Košice, , Slovakia
KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra, , Slovakia
Dionea, s.r.o.
Nové Zámky, , Slovakia
MEDIPA, s.r.o.
Piešťany, , Slovakia
MUDr. Viliam Cibik, PhD, s.r.o.
Pruské, , Slovakia
Medilex s.r.o., Interna ambulancia
Rimavská Sobota, , Slovakia
Plucna ambulancia Hrebenar s.r.o.
Spišská Nová Ves, , Slovakia
SPAOLO s.r.o., Ambulancia vnutorneho lekarstva
Stará Turá, , Slovakia
Privatna urologicka ambulancia, s.r.o.
Trenčín, , Slovakia
MUDr. Zakova, s.r.o.
Trenčín, , Slovakia
Fakutna nemocnica Trnava
Trnava, , Slovakia
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Asan Medical Center
Songpa-gu, Seoul, South Korea
Dong-A University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Gyeonggi-do, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
EAP Centelles
Centelles, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Parc de Salut Mar- Hospital del Mar
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Infektionskliniken, Malarsjukhuset
Eskilstuna, , Sweden
Gothia Forum CTC/Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset
Gothenburg, , Sweden
Avdelningen for kliniska provningar, S-huset
Örebro, , Sweden
Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus
Stockholm, , Sweden
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan (r.o.c.), Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Stockport Nhs Foundation Trust
Stockport, Cheshire, United Kingdom
Fowey River Practice
Fowey, Cornwall, United Kingdom
Oak Tree Surgery
Liskeard, Cornwall, United Kingdom
The Alverton Practise, St Clare Medical Centre
Penzance, Cornwall, United Kingdom
Rame Group Practice, Rame Medical Ltd.
Torpoint, Cornwall, United Kingdom
Royal Devon & Exeter Hospital
Exeter, Devon, United Kingdom
Knowle House Surgery
Plymouth, Devon, United Kingdom
Layton Medical Centre
Blackpool, Lancashire, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
NHS Lothian, Western General Hospital
Edinburgh, Midlothian, United Kingdom
Heart of England NHS Foundation Trust
Birmingham, WEST Midlands, United Kingdom
St James University Hospital
Leeds, , United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation trust
Newcastle upon Tyne, , United Kingdom
Countries
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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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