Clinical trial NCT03090191: Clostridium Difficile Vaccine Efficacy Trial
Official title: A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridium Difficile Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 17535
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 3
timeFrame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
measure: Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 2
timeFrame: From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
measure: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1
timeFrame: Within 7 days after Dose 1 at Month 0
measure: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2
timeFrame: Within 7 days after Dose 2 at Month 1
measure: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3
timeFrame: Within 7 days after Dose 3 at Month 6
measure: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1
timeFrame: Within 7 days after Dose 1 at Month 0
measure: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2
timeFrame: Within 7 days after Dose 2 at Month 1
measure: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3
timeFrame: Within 7 days after Dose 3 at Month 6
measure: Number of Participants Reporting Adverse Events (AEs)
timeFrame: From Day 1 of Dose 1 to 1 Month after Dose 3 (7 Months)
measure: Number of Participants Reporting Serious Adverse Events (SAEs)
timeFrame: From Day 1 of Dose 1 up to 6 months after Dose 3 (up to Month 12)
Secondary outcomes:
measure: Number of All Episodes of CDI (Definition 1 and 2) After Dose 3
timeFrame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
measure: Time to Resolution for Participants With First Primary Episodes of CDI (Definition 1) After Dose 3
timeFrame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
measure: Proportion of Participants Who Required Medical Attention During First Primary Episode of CDI (Definition 1) After Dose 3
timeFrame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
measure: Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 3
timeFrame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
measure: Number of All Episodes of CDI (Definition 1 and 2) After Dose 2
timeFrame: From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
measure: Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 2
timeFrame: From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
measure: Number of First Primary Episode of CDI (Definition 1) After Dose 2 and Before Dose 3
timeFrame: From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses
measure: Number of Participants With Recurrent Episode of CDI (Definition 2) After Dose 2 and Before Dose 3
timeFrame: From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, LLC, An AMR Company
state: Alabama
city: Peoria
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Phoenix VA Health Care System
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Clinical LLC
state: Arizona
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Surprise
country: United States
facility: Clinical Research Institute of Arizona, LLC
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Health Rehabilitation Institute
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Covina
country: United States
facility: California Kidney Specialist
state: California
city: Covina
country: United States
facility: Usborne Family Medicine
state: California
city: Daly City
country: United States
facility: Kaiser Permanente Daly City
state: California
city: Downey
country: United States
facility: Premier Health Research Center, LLC
state: California
city: La Mesa
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System Research Pharmacy
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services, Inc.
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA CTRC Outpatient Unit
state: California
city: Mather
country: United States
facility: VA Northern California Health Care System
state: California
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto Health Care System
state: California
city: Rancho Mirage
country: United States
facility: Covigilant Research, LLC
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: California
city: Redlands
country: United States
facility: VA Loma Linda Healthcare System Ambulatory Care System
state: California
city: Riverside
country: United States
facility: Covigilant Research LLC
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Roseville
state: California
city: Sacramento
country: United States
facility: One Community Health
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento
state: California
city: Sacramento
country: United States
facility: CTSC Clinical Research Center
state: California
city: Sacramento
country: United States
facility: Lawrence J. Ellison Ambulatory Care Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento
state: California
city: San Bernardino
country: United States
facility: Breakthrough Clinical Trials
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: San Dimas
country: United States
facility: California Kidney Specialists
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: Simi Valley
country: United States
facility: Alta California Medical Group
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek
state: California
city: Aurora
country: United States
facility: Clinical Trial Center University of Colorado Denver, School of Medicine
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Clinical & Translational Research Center Clinic
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Clinical & Translational Research Center Outpatient Clinic
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver, School of Medicine
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Department of AIP 2. Pharmacy Bulk Storage
state: Colorado
city: Hamden
country: United States
facility: Gastroenterology Center of Connecticut, PC
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Brandon
country: United States
facility: Florida Sleep Disorder Center of Brandon
state: Florida
city: Brandon
country: United States
facility: Teradan Clinical Trials
state: Florida
city: Chiefland
country: United States
facility: Southeast Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West FL., Inc.
state: Florida
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Reseach, LLC
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites - DeLand Clinical Research Unit
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center Investigational Drug Services
state: Florida
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions,Inc.
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Charisma Medical and Research Center
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Optimus U. Corp.
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: Doctors Research Institute
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: Next Phase Research Alliance
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center, LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Soma Medical Center
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Champaign
country: United States
facility: Christie Clinic, LLC
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr VA Hospital
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic Infectious Diseases
state: Illinois
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Carmel
country: United States
facility: Infectious Disease of Indiana, PSC
state: Indiana
city: Carmel
country: United States
facility: St. Vincent Outpatient Treatment Center
state: Indiana
city: Evansville
country: United States
facility: Deaconess Clinic Mt. Pleasant
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital & Health Care Center
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital and Health Care Center
state: Indiana
city: Mishawaka
country: United States
facility: MOC Research
state: Indiana
city: Sioux City
country: United States
facility: Meridian Clinical Research
state: Iowa
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates, LLC
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Natchitoches
country: United States
facility: Barnum Medical Research Inc
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Center for Primary Care and Wellness
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Annapolis
country: United States
facility: Luminis Health Anne Arundel Medical Center Infusion Center
state: Maryland
city: Annapolis
country: United States
facility: Luminis Health Anne Arundel Medical Center
state: Maryland
city: Annapolis
country: United States
facility: Luminis Health Research Institute: Research Office
state: Maryland
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Canton
country: United States
facility: ClinSite, LLC
state: Michigan
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Sterling Heights
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester, Methodist Hospital Campus
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Gulfport
country: United States
facility: MedPharmics
state: Mississippi
city: Saint Louis
country: United States
facility: Center for Outpatient Health
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Center For Clinical Studies
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health GI Clinic
state: Montana
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Barrett Clinic
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Hillsborough
country: United States
facility: ID Care
state: New Jersey
city: Raritan
country: United States
facility: Amici Clinical Research
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico VA Healthcare System
state: New Mexico
city: Binghamton
country: United States
facility: Meridian Clinical Research LLC
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
city: Durham
country: United States
facility: Duke Early Phase Clinical Research
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital Investigational Drug Services (IDS) Pharmacy
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Tabor City
country: United States
facility: Waterway Primary Care LLC DBA Tabor City Family Medicine
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Progressive Medicine of the Triad, LLC
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Canton
country: United States
facility: Aultman Cardiology Clinical Trials
state: Ohio
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Physicians Office Clifton
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Cincinnati
country: United States
facility: University Of Cincinnati-Internal Medicine Division of Digestive Diseases
state: Ohio
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Incorporated
state: Ohio
city: Dayton
country: United States
facility: PriMED Clinical Research
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Medical Research LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Center For Health Research
state: Oregon
city: Portland
country: United States
facility: Columbia Research Group, Inc.
state: Oregon
city: Portland
country: United States
facility: VA Portland Healthcare System
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network/Network Office of Research and Innovation
state: Pennsylvania
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Erie
country: United States
facility: Westminster Family Medicine
state: Pennsylvania
city: Erie
country: United States
facility: Liberty Family Practice
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Charleston
country: United States
facility: Medical Research South, LLC
state: South Carolina
city: Little River
country: United States
facility: Main Street Physician's Care - Waterway
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol, PC
state: Tennessee
city: Bristol
country: United States
facility: PMG Research of Bristol, LLC
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research, Inc. d/b/a PMG Research of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research,Inc. d/b/a PMG Research of Knoxville
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Tullahoma
country: United States
facility: Trinity Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A.
state: Texas
city: Dallas
country: United States
facility: Synexus US, LP
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Care, PLLC
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center at Fort Worth
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Kelsey Research Foundation
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Mesquite
country: United States
facility: Synexus US, dba Research Across America
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Healthcare System, Audie L Murphy Hospital
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Draper
country: United States
facility: J. Lewis Research Inc. / Foothill Family Clinic Draper
state: Utah
city: Riverton
country: United States
facility: Advanced Clinical Research/Gut Whisperer
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc./Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J Lewis Research, Incorporated
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. - Jordan River Family Medicine
state: Utah
city: Annandale
country: United States
facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center LLC
state: Virginia
city: Salem
country: United States
facility: Salem VAMC
state: Virginia
city: Port Orchard
country: United States
facility: Frandsen Family Medicine DBA Sound Medical Research
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Tacoma
country: United States
facility: Universal Research Group, LLC
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Marshfield
country: United States
facility: Marshfield Medical Center - Marshfield
state: Wisconsin
city: C.a.b.a.
country: Argentina
facility: Hospital Aleman
state: Buenos Aires
city: C.a.b.a.
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
city: C.a.b.a.
country: Argentina
facility: Centro Médico Dra. De Salvo
state: Buenos Aires
city: Rosario
country: Argentina
facility: Sanatorio Británico S.A.
state: Santa FE
city: Cordoba
country: Argentina
facility: Hospital Nuestra Senora de la Misericordia
city: Kanwal
country: Australia
facility: Paratus Clinical Pty Ltd
state: New South Wales
city: Maroiubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Maroubra
country: Australia
facility: Maroubra Medical Centre
state: New South Wales
city: Westmead
country: Australia
facility: University Clinic Pharmacy
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Sherwood
country: Australia
facility: Austrials Pty Ltd
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd & Mater Medical Research Institute Ltd
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Health - Box Hill Hospital
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU de Liège - Domaine universitaire du Sart Tilman
city: Kazanlak
country: Bulgaria
facility: "MHAT- Dr. Hristo Stambolski" EOOD
city: Kozloduy
country: Bulgaria
facility: MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department
city: Lom
country: Bulgaria
facility: MHAT "Sv. Nikolay Chudotvorets" EOOD
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sveti Georgi" EAD
city: Ruse
country: Bulgaria
facility: "Center for Mental Health - Ruse" EOOD
city: Ruse
country: Bulgaria
facility: SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD
city: Sevlievo
country: Bulgaria
facility: ''Medical Center-1-Sevlievo'' EOOD
city: Silistra
country: Bulgaria
facility: MHAT -Silistra AD
city: Sliven
country: Bulgaria
facility: MC ''Tsaritsa Yoanna''EOOD
city: Sofia
country: Bulgaria
facility: MC 'Cardiohelp' EOOD
city: Sofia
country: Bulgaria
facility: "Acibadem City Clinic University Hospital" EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Ead
city: Sofia
country: Bulgaria
facility: MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases
city: Troyan
country: Bulgaria
facility: "SHATPD-Troyan" EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: MC Medica Plus OOD
city: Vidin
country: Bulgaria
facility: MHAT ''Sveta Petka" AD
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital General Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: Manna Research Inc. (Toronto)
state: Ontario
city: Chicoutimi
country: Canada
facility: Intermed Groupe Santé
state: Quebec
city: Gatineau
country: Canada
facility: Q & T Research Outaouais Inc.
state: Quebec
city: Greenfield Park
country: Canada
facility: Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
state: Quebec
city: Quebec
country: Canada
facility: Centre de recherche du CHU de Quebec-Universite Laval
city: Quebec
country: Canada
facility: Centre de recherche Saint-Louis
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Temuco
country: Chile
facility: Centro de Investigacion Clínica del Sur
state: IX Region DE LA Araucania
city: Antofagasta
country: Chile
facility: Psicomed Esudios Medicos
state: Region DE Antofagasta
city: Temuco
country: Chile
facility: Hospital Dr. Hernan Henriquez Aravena
state: Region DE LA Araucania
city: Santiago
country: Chile
facility: Biomedica Research Group
state: Región Metropolitana
city: Santiago
country: Chile
facility: Fundacion Arriaran
state: Región Metropolitana
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica - CIC
state: Antioquia
city: Medellin
country: Colombia
facility: Instituto de Coloproctologia ICO
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda.
state: Atlantico
city: Manizales
country: Colombia
facility: Asociación IPS Médicos Internistas de Caldas
state: Caldas
city: Bogota
country: Colombia
facility: Centro de Investigaciones - MedPlus Centro de Recuperación Integral S.A.S.
state: D.c.
city: Armenia
country: Colombia
facility: Fundación Cardiomet CEQUIN
state: Quindío
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia
state: Santander
city: Cali
country: Colombia
facility: Fundacion Valle del Lili
state: Valle DEL Cauca
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A.
state: Valle DEL Cauca
city: Brno
country: Czechia
facility: Doktor Brno s.r.o.
state: Czech
city: Benatky nad Jizerou
country: Czechia
facility: Ordinace vseobecneho praktickeho lekare
city: Kyjov
country: Czechia
facility: Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni
city: Opava
country: Czechia
facility: Slezska Nemocnice v Opave, prispevkova organizace
city: Policka
country: Czechia
facility: Policska nemocnice s.r.o.,
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Pribram I.
country: Czechia
facility: Oblastni nemocnice Pribram, a.s.
city: Roznov pod Radhostem
country: Czechia
facility: Interna a kardiologie s.r.o.
city: Slany
country: Czechia
facility: Nemocnice Slany, p.o.
city: Slany
country: Czechia
facility: Sarkamed s.r.o.
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Dijon cedex
country: France
facility: CHU DIJON BOURGOGNE- Hopital Francois Mitterrand
city: Paris
country: France
facility: CIC Vaccinologie Cochin- Pasteur 1417
city: Saint Priest en Jarez
country: France
facility: Hopital Nord-CHU Saint Etienne
city: Tours Cedex 09
country: France
facility: CHRU de Tours- Hopital Bretonneau
city: Berlin
country: Germany
facility: Emovis GmbH
city: Cottbus
country: Germany
facility: MECS Cottbus GmbH
city: Dresden
country: Germany
facility: Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann
city: Essen
country: Germany
facility: Universitaetsklinikum Essen, Klinik fuer Infektiologie
city: Leipzig
country: Germany
facility: EUGASTRO GmbH/ Praxis
city: Leipzig
country: Germany
facility: SIBAmed Studienzentrum GmbH & Co.KG
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Westerstede
country: Germany
facility: Praxis Dr. med. J. Springub/ W. Schwarz
city: Westerstede
country: Germany
facility: Studienzentrum Nordwest
city: Wuerzburg
country: Germany
facility: Klinikum Wuerzburg Mitte gGmbH
city: Baja
country: Hungary
facility: Bajai Szent Rokus Korhaz, II Belgyogyaszat
city: Balatonfured
country: Hungary
facility: DRC Kft.
city: Budapest
country: Hungary
facility: Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly
city: Budapest
country: Hungary
facility: Semmelweis Egyetem III. Sz. Belgyogyaszati Klinika
city: Debrecen
country: Hungary
facility: ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia
city: Encs
country: Hungary
facility: CRU Hungary Kft.
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly
city: Kasugai
country: Japan
facility: Tokai Memorial Hospital
state: Aichi
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Daido Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Kamiiida daiichi General Hospital
state: Aichi
city: Iizuka
country: Japan
facility: Iizuka Hospital
state: Fukuoka
city: Itoshima
country: Japan
facility: Seishinkai Inoue Hospital
state: Fukuoka
city: Kasuga
country: Japan
facility: Fukuoka Tokushukai Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kenwakai Otemachi Hospital
state: Fukuoka
city: Fukuyama
country: Japan
facility: Fukuyama City Hospital
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Miyanomori Memorial Hospital
state: Hokkaido
city: Koga
country: Japan
facility: Medical Corporation Tokushukai Koga General Hospital
state: Ibaraki
city: Mito
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
state: Kanagawa
city: Osaki
country: Japan
facility: Osaki Citizen Hospital
state: Miyagi
city: Matsumoto-City
country: Japan
facility: Social Medical Care Corporation Hose-kai Marunouchi Hospital
state: Nagano Prefecture
city: Daito
country: Japan
facility: Nozaki Tokushukai Hospital
state: Osaka
city: Kusatsu
country: Japan
facility: Omi Medical Center
state: Shiga
city: Yaizu
country: Japan
facility: Yaizu City Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Nerima-ku
country: Japan
facility: Nerima General Hospital
state: Tokyo
city: Toshima-ku
country: Japan
facility: Sekino Hospital
state: Tokyo
city: Fukui
country: Japan
facility: Fukui-Ken Saiseikai Hospital
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Saga
country: Japan
facility: Saga-Ken Medical Centre Koseikan
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon-do
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: San Martin de Porres
country: Peru
facility: Hospital Cayetano Heredia
state: Lima
city: Cusco
country: Peru
facility: Hospital Nacional Adolfo Guevara Velasco
city: Lima
country: Peru
facility: Clinica Internacional S.A
city: Trujillo, La Libertad
country: Peru
facility: Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o Oddzial w Gdansku
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Katowice
country: Poland
facility: SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach
city: Leczna
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o. Oddział w Poznaniu
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Aveiro
country: Portugal
facility: Centro Hospitalar do Baixo Vouga, E.P.E.
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimaraes
country: Portugal
facility: Hospital Senhora de Oliveira - Guimaraes, E.P.E.
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
city: Bojnice
country: Slovakia
facility: PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia
city: Bratislava
country: Slovakia
facility: Medak s.r.o., Gastroenterologicka ambulancia
city: Kosice
country: Slovakia
facility: Stalerg, s.r.o.
city: Nitra
country: Slovakia
facility: KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
city: Nove Zamky
country: Slovakia
facility: Dionea, s.r.o.
city: Piestany
country: Slovakia
facility: MEDIPA, s.r.o.
city: Pruske
country: Slovakia
facility: MUDr. Viliam Cibik, PhD, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: Medilex s.r.o., Interna ambulancia
city: Spisska Nova Ves
country: Slovakia
facility: Plucna ambulancia Hrebenar s.r.o.
city: Stara Tura
country: Slovakia
facility: SPAOLO s.r.o., Ambulancia vnutorneho lekarstva
city: Trencin
country: Slovakia
facility: Privatna urologicka ambulancia, s.r.o.
city: Trencin
country: Slovakia
facility: MUDr. Zakova, s.r.o.
city: Trnava
country: Slovakia
facility: Fakutna nemocnica Trnava
city: Centelles
country: Spain
facility: EAP Centelles
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Parc de Salut Mar- Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Eskilstuna
country: Sweden
facility: Infektionskliniken, Malarsjukhuset
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset
city: Göteborg
country: Sweden
facility: Gothia Forum CTC/Sahlgrenska Universitetssjukhuset
city: Orebro
country: Sweden
facility: Avdelningen for kliniska provningar, S-huset
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
state: Taiwan (r.o.c.)
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Stockport
country: United Kingdom
facility: Stockport Nhs Foundation Trust
state: Cheshire
city: Fowey
country: United Kingdom
facility: Fowey River Practice
state: Cornwall
city: Liskeard
country: United Kingdom
facility: Oak Tree Surgery
state: Cornwall
city: Penzance
country: United Kingdom
facility: The Alverton Practise, St Clare Medical Centre
state: Cornwall
city: Torpoint
country: United Kingdom
facility: Rame Group Practice, Rame Medical Ltd.
state: Cornwall
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
state: Devon
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
state: Devon
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
state: Lancashire
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
state: Leicestershire
city: Edinburgh
country: United Kingdom
facility: NHS Lothian, Western General Hospital
state: Midlothian
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
state: WEST Midlands
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: