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Clostridium Difficile Vaccine Efficacy Trial (Clover)

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ClinicalTrials.gov Identifier: NCT03090191
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Biological: Clostridium difficile vaccine Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15776 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : September 28, 2020
Estimated Study Completion Date : September 28, 2020

Arm Intervention/treatment
Experimental: Clostridium difficile vaccine Biological: Clostridium difficile vaccine
Toxoid-based Clostridium difficile vaccine

Placebo Comparator: Placebo Biological: Placebo
Normal saline solution (0.9% sodium chloride)




Primary Outcome Measures :
  1. First primary case CDI incidence [ Time Frame: Up to 3 years after the 3rd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)

  2. First primary case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)

  3. Percentage of subjects reporting local reactions [ Time Frame: Up to 7 days following each vaccination, 1, 2, and 3 ]
    Pain, erythema, and induration, as self-reported on electronic diaries

  4. Percentage of subjects reporting systemic events [ Time Frame: Up to 7 days following each vaccination, 1, 2, and 3 ]
    Fever, vomiting, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain, as self-reported on electronic diaries

  5. Percentage of subjects reporting nonserious adverse events [ Time Frame: Up to 7 months after the first dose ]
    As elicited by investigational site staff

  6. Percentage of subjects reporting serious adverse events [ Time Frame: Up to 12 months after the first dose ]
    As elicited by investigational site staff


Secondary Outcome Measures :
  1. Recurrent case CDI incidence [ Time Frame: Up to 3 years after the 3rd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)

  2. Recurrent case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)

  3. First primary case CDI incidence [ Time Frame: Up to 3 years after the 3rd dose ]
    Per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile)

  4. First primary case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile)

  5. Recurrent case CDI incidence [ Time Frame: Up to 3 years after the 3rd dose ]
    Per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile)

  6. Recurrent case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile)

  7. In subjects that receive only 2 doses, first primary CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)

  8. In subjects that receive only 2 doses, recurrent case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)

  9. In subjects that receive only 2 doses, first primary case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile)

  10. In subjects that receive only 2 doses, recurrent case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile)

  11. All case CDI incidence [ Time Frame: Up to 3 years after the 3rd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)

  12. All case CDI incidence [ Time Frame: Up to 3 years after the 3rd dose ]
    Per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile)

  13. All case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)

  14. All case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile)

  15. Mean time to resolution of diarrhea in first primary cases of CDI [ Time Frame: Up to 3.5 years after enrolment ]
    Confirmed at the central laboratory

  16. Proportion of subjects experiencing a first primary episode of CDI who have a non-protocol-related medically attended visit during the CDI episode [ Time Frame: Up to 3.5 years after enrolment ]
    Confirmed at the central laboratory

  17. Mean ATLAS (age, treatment with systemic antibiotics during CDI therapy, leukocyte count, serum albumin, and serum creatinine) score [ Time Frame: Up to 3.5 years after enrolment ]
    Score calculated based on age, treatment with systemic antibiotics during CDI therapy, leukocyte count, serum albumin, and serum creatinine



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090191


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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United States, Alabama
North Alabama Research Center, LLC Recruiting
Athens, Alabama, United States, 35611
Medical Affiliated Research Center, Inc. Recruiting
Huntsville, Alabama, United States, 35801
Coastal Clinical Research, Inc. Recruiting
Mobile, Alabama, United States, 36608
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The Pain Center of Arizona Recruiting
Peoria, Arizona, United States, 85381
Phoenix VA Health Care System Recruiting
Phoenix, Arizona, United States, 85012
Phoenix Clinical LLC Recruiting
Phoenix, Arizona, United States, 85014
MedPharmics, LLC Not yet recruiting
Phoenix, Arizona, United States, 85015
HOPE Research Institute Recruiting
Phoenix, Arizona, United States, 85018
The Pain Center of Arizona Recruiting
Phoenix, Arizona, United States, 85018
Clinical Research Institute of Arizona, LLC Recruiting
Surprise, Arizona, United States, 85374
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Baptist Health Center for Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
Arkansas Gastroenterology Recruiting
North Little Rock, Arkansas, United States, 72117
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San Gorgonio Memorial Hospital Recruiting
Banning, California, United States, 92220
Kaiser Permanente Daly City Recruiting
Daly City, California, United States, 94015
Premier Health Research Center, LLC Recruiting
Downey, California, United States, 90241
VA Loma Linda Health Care System Recruiting
Loma Linda, California, United States, 92357
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States, 90822
Academic Medical Research Institute Recruiting
Los Angeles, California, United States, 90022
Ronald Reagan Med Center - Univeristy of California, Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90095
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
UCLA CTRC Outpatient Unit Recruiting
Los Angeles, California, United States, 90095
VA Northern California Health Care System Recruiting
Mather, California, United States, 95655
Kaiser Permanente Vaccine Study Center Not yet recruiting
Oakland, California, United States, 94612
Veterans Affairs Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Covigilant Research, LLC Recruiting
Rancho Mirage, California, United States, 92270
Paradigm Clinical Research Center Recruiting
Redding, California, United States, 96001
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Roseville, California, United States, 95661
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Sacramento, California, United States, 95815
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Sacramento, California, United States, 95817
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Sacramento, California, United States, 95823
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San Diego, California, United States, 92117
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San Diego, California, United States, 92161
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San Dimas, California, United States, 91773
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San Jose, California, United States, 95119
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Santa Clara, California, United States, 95051
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Simi Valley, California, United States, 93065
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Walnut Creek, California, United States, 94596
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Aurora, Colorado, United States, 80045
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Aurora, Colorado, United States, 80045
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Aurora, Colorado, United States, 80045
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Aurora, Colorado, United States, 80045
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Hamden, Connecticut, United States, 06518
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Hamden, Connecticut, United States, 06518
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Milford, Connecticut, United States, 06460
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Bay Pines VA Healthcare System Recruiting
Bay Pines, Florida, United States, 33744
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Brandon, Florida, United States, 33511
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Brandon, Florida, United States, 33511
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Chiefland, Florida, United States, 32626
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Clearwater, Florida, United States, 33756
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Coral Gables, Florida, United States, 33134
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Coral Gables, Florida, United States, 33134
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DeLand, Florida, United States, 32720
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Fleming Island, Florida, United States, 32003
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Gainesville, Florida, United States, 32608
Malcom Randall VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
Indago Research & Health Center, Inc. Not yet recruiting
Hialeah, Florida, United States, 33012
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Jacksonville, Florida, United States, 32256
Multi-Specialty Research Associates, Inc. Not yet recruiting
Lake City, Florida, United States, 32055
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Lauderdale Lakes, Florida, United States, 33319
Ocean Blue Medical Research Center, Inc. Recruiting
Miami Springs, Florida, United States, 33166
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33142
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Miami, Florida, United States, 33144
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Miami, Florida, United States, 33145
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Naples, Florida, United States, 34102
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Orlando, Florida, United States, 32801
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Orlando, Florida, United States, 32819
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Pembroke Pines, Florida, United States, 33026
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Port Orange, Florida, United States, 32127
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West Palm Beach, Florida, United States, 33406
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Williston, Florida, United States, 32696
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Savannah, Georgia, United States, 31406
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Honolulu, Hawaii, United States, 96814
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Idaho Falls, Idaho, United States, 83404
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Meridian, Idaho, United States, 83642
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Meridian, Idaho, United States, 83646
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PMG Research of Christie Clinic, LLC Recruiting
Champaign, Illinois, United States, 61822
Edward Hines Jr VA Hospital Recruiting
Hines, Illinois, United States, 60141
Springfield Clinic Infectious Diseases Recruiting
Springfield, Illinois, United States, 62702
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Springfield, Illinois, United States, 62703
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Community Clinical Research Center Recruiting
Anderson, Indiana, United States, 46011
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Carmel, Indiana, United States, 46032
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Carmel, Indiana, United States, 46032
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Evansville, Indiana, United States, 47725
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Indianapolis, Indiana, United States, 46260
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Heartland Research Associates, LLC Recruiting
Wichita, Kansas, United States, 67205
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Kentucky Pediatric/Adult Research Recruiting
Bardstown, Kentucky, United States, 40004
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Lexington, Kentucky, United States, 40509
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Marrero, Louisiana, United States, 70072
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Metairie, Louisiana, United States, 70006
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Natchitoches, Louisiana, United States, 71457
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New Orleans, Louisiana, United States, 70121
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New Orleans, Louisiana, United States, 70121
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Annapolis, Maryland, United States, 21401
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Annapolis, Maryland, United States, 21401
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Annapolis, Maryland, United States, 21401
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Annapolis, Maryland, United States, 21401
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Ann Arbor, Michigan, United States, 48105
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Canton, Michigan, United States, 48187
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Flint, Michigan, United States, 48504
Revival Research Institute, LLC Active, not recruiting
Sterling Heights, Michigan, United States, 48313
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Mayo Clinic Rochester, Methodist Hospital Campus Recruiting
Rochester, Minnesota, United States, 55902
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
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MedPharmics, LLC Recruiting
Biloxi, Mississippi, United States, 39531
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Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110-1093
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Center for Advanced Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Center For Clinical Studies Recruiting
Saint Louis, Missouri, United States, 63110
Sundance Clinical Research Recruiting
Saint Louis, Missouri, United States, 63141
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Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research Recruiting
Bozeman, Montana, United States, 59718
Mercury Street Medical Group, PLLC Recruiting
Butte, Montana, United States, 59701
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Meridian Clinical Research, LLC Recruiting
Norfolk, Nebraska, United States, 68701
Barrett Clinic Recruiting
Omaha, Nebraska, United States, 68128
Meridian Clinical Research, LLC Recruiting
Omaha, Nebraska, United States, 68134
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ID Care Recruiting
Hillsborough, New Jersey, United States, 08844
Amici Clinical Research Recruiting
Martinsville, New Jersey, United States, 08836
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Somers Point, New Jersey, United States, 08244
Amici Clinical Research Recruiting
Warren, New Jersey, United States, 07059
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New Mexico VA Healthcare System Recruiting
Albuquerque, New Mexico, United States, 87108
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United Medical Associates Recruiting
Binghamton, New York, United States, 13901
Regional Clinical Research, Inc. Recruiting
Endwell, New York, United States, 13760
Rochester Clinical Research Recruiting
Rochester, New York, United States, 14609
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Waterway Primary Care LLC dba Calabash Medical Center Recruiting
Calabash, North Carolina, United States, 28467
Copernicus Group IRB Recruiting
Cary, North Carolina, United States, 27513
PMG Research of Raleigh, LLC Recruiting
Cary, North Carolina, United States, 27518
PMG Research of Charlotte, LLC Recruiting
Charlotte, North Carolina, United States, 28209
Durham VAMC Recruiting
Durham, North Carolina, United States, 27705
Duke Early Phase Clinical Research Recruiting
Durham, North Carolina, United States, 27710
Duke University Hospital Investigational Drug Services (IDS) Pharmacy Recruiting
Durham, North Carolina, United States, 27710
PharmQuest Recruiting
Greensboro, North Carolina, United States, 27408
PMG Research of Hickory, LLC Recruiting
Hickory, North Carolina, United States, 28601
PMG Research of Raleigh, LLC Recruiting
Raleigh, North Carolina, United States, 27609
Wake Research Associates, LLC Recruiting
Raleigh, North Carolina, United States, 27612
PMG Research of Rocky Mount, LLC Recruiting
Rocky Mount, North Carolina, United States, 27804
PMG Research of Salisbury, LLC Recruiting
Salisbury, North Carolina, United States, 28144
Waterway Primary Care LLC DBA Tabor City Family Medicine Recruiting
Tabor City, North Carolina, United States, 28463
PMG Research of Wilmington, LLC Recruiting
Wilmington, North Carolina, United States, 28401
Clinical Trials of America-NC, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
PMG Research of Winston-Salem, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
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Lillestol Research LLC Recruiting
Fargo, North Dakota, United States, 58103
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Aultman Cardiology Clinical Trials Recruiting
Canton, Ohio, United States, 44710
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Canton, Ohio, United States, 44710
UC Health Physicians Office Clifton Recruiting
Cincinnati, Ohio, United States, 45219
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Sterling Research Group, Ltd. Recruiting
Cincinnati, Ohio, United States, 45246
University Of Cincinnati-Internal Medicine Division of Digestive Diseases Recruiting
Cincinnati, Ohio, United States, 45267
Louis Stokes Cleveland VA Medical Center Recruiting
Cleveland, Ohio, United States, 44106
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
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Dayton, Ohio, United States, 45419
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Mentor, Ohio, United States, 44060
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IPS Research Company Active, not recruiting
Oklahoma City, Oklahoma, United States, 73103
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Kaiser Permanente Center for Health Research Recruiting
Portland, Oregon, United States, 97227
Columbia Research Group, Inc. Recruiting
Portland, Oregon, United States, 97239
VA Portland Healthcare System Recruiting
Portland, Oregon, United States, 97239
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Allentown, Pennsylvania, United States, 18103
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
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Camp Hill, Pennsylvania, United States, 17011
Westminster Family Medicine Recruiting
Erie, Pennsylvania, United States, 16506
Liberty Family Practice Recruiting
Erie, Pennsylvania, United States, 16508
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
VA Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Preferred Primary Care Physicians, Inc. Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Preferred Primary Care Physicians, Inc. Recruiting
Uniontown, Pennsylvania, United States, 15401
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Omega Medical Research Recruiting
Warwick, Rhode Island, United States, 02886
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Medical Research South, LLC Recruiting
Charleston, South Carolina, United States, 29407
Coastal Carolina Research Center Recruiting
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Meridian Clinical Research Recruiting
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Holston Medical Group Recruiting
Bristol, Tennessee, United States, 37620
Internal Medicine and Pediatric Associates of Bristol, PC Recruiting
Bristol, Tennessee, United States, 37620
PMG Research of Bristol, LLC Recruiting
Bristol, Tennessee, United States, 37620
PMG Research, Inc. d/b/a PMG Research of Knoxville Recruiting
Knoxville, Tennessee, United States, 37912
PMG Research,Inc. d/b/a PMG Research of Knoxville Recruiting
Knoxville, Tennessee, United States, 37938
Clinical Neuroscience Solutions, Inc. Not yet recruiting
Memphis, Tennessee, United States, 38119
Trinity Clinical Research Recruiting
Tullahoma, Tennessee, United States, 37388
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Tekton Research, Inc. Recruiting
Austin, Texas, United States, 78745
Research Across America Recruiting
Dallas, Texas, United States, 75234
North Texas Infectious Diseases Consultants, P.A. Not yet recruiting
Dallas, Texas, United States, 75246
Ventavia Research Group, LLC Recruiting
Fort Worth, Texas, United States, 76104
University of North Texas Health Science Center at Fort Worth Recruiting
Fort Worth, Texas, United States, 76107
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Kelsey Research Foundation Recruiting
Houston, Texas, United States, 77025
Kelsey-Seybold Clinic Recruiting
Houston, Texas, United States, 77025
Texas Center for Drug Development, Inc. Recruiting
Houston, Texas, United States, 77081
Research Across America Recruiting
Mesquite, Texas, United States, 75149
Clinical Trials of Texas, Inc. Recruiting
San Antonio, Texas, United States, 78229
Diagnostics Research Group Recruiting
San Antonio, Texas, United States, 78229
South Texas Veterans Healthcare System, Audie L Murphy Hospital Recruiting
San Antonio, Texas, United States, 78229
Martin Diagnostic Clinic Recruiting
Tomball, Texas, United States, 77375
United States, Utah
J. Lewis Research Inc. / Foothill Family Clinic Draper Recruiting
Draper, Utah, United States, 84020
Advanced Clinical Research/Gut Whisperer Recruiting
Riverton, Utah, United States, 84065
J. Lewis Research, Inc./Foothill Family Clinic Recruiting
Salt Lake City, Utah, United States, 84109
J Lewis Research, Incorporated Recruiting
Salt Lake City, Utah, United States, 84121
J. Lewis Research, Inc. - Jordan River Family Medicine Recruiting
South Jordan, Utah, United States, 84095
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases, LLC Recruiting
Annandale, Virginia, United States, 22003
Virginia Research Center Recruiting
Midlothian, Virginia, United States, 23114
Salem VAMC Recruiting
Salem, Virginia, United States, 24153
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Frandsen Family Medicine DBA Sound Medical Research Recruiting
Port Orchard, Washington, United States, 98366
Western Institutional Review Board Recruiting
Puyallup, Washington, United States, 98374
Multicare Health System Recruiting
Tacoma, Washington, United States, 98405
Wenatchee Valley Hospital & Clinics Recruiting
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Argentina
Sanatorio Británico S.A. Not yet recruiting
Rosario, Santa FE, Argentina, S2000CVB
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Buenos Aires, Argentina, C1221AFC
Hospital San Roque Not yet recruiting
Cordoba, Argentina, 5000
Sanatorio Allende S.A. Not yet recruiting
Cordoba, Argentina, 5000
Hospital Nuestra Senora de la Misericordia Not yet recruiting
Cordoba, Argentina, X5000JRD
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Pcia. De Buenos Aires, Argentina
Hospital Dr. Jose Maria Cullen Not yet recruiting
Santa Fe, Argentina, 3000
Australia, New South Wales
Paratus Clinical Pty Ltd Active, not recruiting
Kanwal, New South Wales, Australia, 2259
Australian Clinical Research Network Recruiting
Maroubra, New South Wales, Australia, 2035
University Clinic Pharmacy Recruiting
Westmead, New South Wales, Australia, 2145
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Austrials Pty Ltd Recruiting
Sherwood, Queensland, Australia, 4075
Mater Misericordiae Ltd & Mater Medical Research Institute Ltd Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Eastern Health - Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Emeritus Research Recruiting
Camberwell, Victoria, Australia, 3124
Barwon Health Recruiting
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
UZ Leuven Recruiting
Leuven, Belgium, 3000
CHU de Liège - Domaine universitaire du Sart Tilman Recruiting
Liege, Belgium, 4000
Bulgaria
"MHAT- Dr. Hristo Stambolski" EOOD Recruiting
Kazanlak, Bulgaria, 6100
MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department Recruiting
Kozloduy, Bulgaria, 3320
MHAT "Sv. Nikolay Chudotvorets" EOOD Recruiting
Lom, Bulgaria, 3600
UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence Recruiting
Pleven, Bulgaria, 5800
UMHAT "Sveti Georgi" EAD Recruiting
Plovdiv, Bulgaria, 4002
"Center for Mental Health - Ruse" EOOD Recruiting
Ruse, Bulgaria, 7000
SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD Recruiting
Ruse, Bulgaria, 7002
''Medical Center-1-Sevlievo'' EOOD Recruiting
Sevlievo, Bulgaria, 5400
MHAT -Silistra AD Recruiting
Silistra, Bulgaria, 7500
MC ''Tsaritsa Yoanna''EOOD Recruiting
Sliven, Bulgaria, 8800
MC 'Kardiohelp' EOOD Recruiting
Sofia, Bulgaria, 1142
"Acibadem City Clinic University Hospital" EOOD Recruiting
Sofia, Bulgaria, 1407
Acibadem City Clinic Tokuda Ead Recruiting
Sofia, Bulgaria, 1407
MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases Recruiting
Sofia, Bulgaria, 1750
"SHATPD-Troyan" EOOD Recruiting
Troyan, Bulgaria, 5600
MC Medica Plus OOD Recruiting
Veliko Tarnovo, Bulgaria, 5000
MHAT ''Sveta Petka" AD Recruiting
Vidin, Bulgaria, 3700
Canada, British Columbia
Vancouver Coastal Health Research Institution Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Canada, Ontario
The Ottawa Hospital General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
The Ottawa Hospital Civic Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Manna Research Inc. (Toronto) Recruiting
Toronto, Ontario, Canada, M9W4L6
Canada, Quebec
Q & T Research Chicoutimi Recruiting
Chicoutimi, Quebec, Canada, G7H 7Y8
Q & T Research Outaouais Inc. Recruiting
Gatineau, Quebec, Canada, J8Y 6S8
Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Comite d'ethique de la recherche - Hopital Charles LeMoyne - Ciss de la Monteregie-Centre Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
CIUSSS de l'Estrie - CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec Recruiting
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Canada
Comite d'ethique de la recherche du CIUSSS de l'Estrie- CHUS Recruiting
Quebec, Canada, G1E 7G9
Centre de recherche Saint-Louis Recruiting
Quebec, Canada, G1W 4R4
ALPHA Recherche Clinique Recruiting
Quebec, Canada, G3K 2P8
Chile
Centro de Investigacion Clínica del Sur Recruiting
Temuco, IX Region DE LA Araucania, Chile, 4781156
Comite Etico Cientifico del Servicio de Salud Metropolitano Oriente Recruiting
Antofagasta, Region DE Antofagasta, Chile, 1270244
Psicomed Esudios Medicos Recruiting
Antofagasta, Region DE Antofagasta, Chile, 1270244
Hospital Dr. Hernan Henriquez Aravena Recruiting
Temuco, Region DE LA Araucaria, Chile, 4781151
Biomedica Research Group Recruiting
Santiago, Región Metropolitana, Chile, 7500710
Fundacion Arriaran Recruiting
Santiago, Región Metropolitana, Chile, 8360159
Centro de Investigaciones Clinicas Viña del Mar Ltda. Not yet recruiting
Vina del Mar, Valparaíso, Chile, 25240364
Colombia
Hospital Pablo Tobon Uribe Recruiting
Medellin, Antioquia, Colombia, 050001
Fundacion Centro de Investigacion Clinica - CIC Recruiting
Medellin, Antioquia, Colombia, 050021
Instituto de Coloproctologia ICO Recruiting
Medellin, Antioquia, Colombia, 050025
Clinica de la Costa Ltda. Recruiting
Barranquilla, Atlantico, Colombia, 080020
Asociación IPS Médicos Internistas de Caldas Recruiting
Manizales, Caldas, Colombia, 170004
Centro de Investigaciones Medplus Medicina Prepagada Recruiting
Bogota, D.c., Colombia, 110221
Fundación Cardiomet CEQUIN Recruiting
Armenia, Quindío, Colombia, 630004
Fundacion Cardiovascular de Colombia Recruiting
Floridablanca, Santander, Colombia, 681002
Fundacion Valle del Lili Recruiting
Cali, Valle DEL Cauca, Colombia, 760032
Centro Medico Imbanaco de Cali S.A. Recruiting
Cali, Valle DEL Cauca, Colombia, 760043
Czechia
Doktor Brno s.r.o. Recruiting
Brno, Czech, Czechia, 65622
Nemocnice Kyjov Recruiting
Kyjov, Czech, Czechia, 69701
Ordinace vseobecneho praktickeho lekare Recruiting
Benatky nad Jizerou, Czechia, 29471
Slezska Nemocnice v Opave, prispevkova organizace Recruiting
Opava, Czechia, 74601
Policska nemocnice s.r.o., Recruiting
Policka, Czechia, 572 01
Fakultni nemocnice v Motole, Interni klinika 2. LF UK a FN Motol Recruiting
Praha 5, Czechia, 150 06
Oblastni nemocnice Pribram, a.s. Recruiting
Pribram I., Czechia, 26101
Interna a kardiologie s.r.o. Recruiting
Roznov pod Radhostem, Czechia, 756 61
Nemocnice Slany, p.o. Recruiting
Slany, Czechia, 274 01
Sarkamed s.r.o. Recruiting
Slany, Czechia, 27401
Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem Recruiting
Usti nad Labem, Czechia, 401 13
Finland
Kokkola Vaccine Research Clinic Recruiting
Maximin Liikekeskus, Kokkola, Finland, 67100
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029 HUS
Oulu Vaccine Research Clinic Recruiting
Oulu, Finland, 90220
Pori Vaccine Research Clinic Recruiting
Pori, Finland, 28100
Tampere Vaccine Research Clinic Recruiting
Tampere, Finland, 33100
Turku Vaccine Research Clinic Recruiting
Turku, Finland, 20520
France
CHU DIJON BOURGOGNE- Hopital Francois Mitterrand Recruiting
Dijon cedex, France, 21079
CIC Vaccinologie Cochin- Pasteur 1417 Recruiting
Paris, France, 75014
Hopital Nord-CHU Saint Etienne Recruiting
Saint Priest en Jarez, France, 42270
CHRU de Tours- Hopital Bretonneau Recruiting
Tours Cedex 09, France, 37044
Germany
Emovis GmbH Recruiting
Berlin, Germany, 10629
MECS Cottbus GmbH Active, not recruiting
Cottbus, Germany, 03050
Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann Recruiting
Dresden, Germany, 01279
Universitaetsklinikum Essen, Klinik fuer Infektiologie Recruiting
Essen, Germany, 45147
EUGASTRO GmbH/ Praxis Recruiting
Leipzig, Germany, 04103
SIBAmed Studienzentrum GmbH & Co.KG Recruiting
Leipzig, Germany, 04103
Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut Recruiting
Leipzig, Germany, 04249
Universitaetsmedizin Rostock Recruiting
Rostock, Germany, 18057
MALU medizinische Studien GmbH Active, not recruiting
Wardenburg, Germany, 26203
Studienzentrum Nordwest Recruiting
Westerstede, Germany, 26655
Klinikum Wuerzburg Mitte gGmbH Recruiting
Wuerzburg, Germany, 97070
Hungary
Bajai Szent Rokus Korhaz, II Belgyogyaszat Recruiting
Baja, Hungary, 6500
DRC Kft. Recruiting
Balatonfured, Hungary, 8230
Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly Recruiting
Budapest, Hungary, 1021
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet, I. Belgyogyaszati Osztaly Recruiting
Budapest, Hungary, 1097
Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly Terminated
Budapest, Hungary, 1121
Semmelweis Egyetem, III. sz. Belgyogyaszati Klinika Recruiting
Budapest, Hungary, 1125
ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia Recruiting
Debrecen, Hungary, 4031
Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly Recruiting
Kaposvar, Hungary, 7400
CRU Hungary Kft. Recruiting
Miskolc, Hungary, 3529
Japan
Tokai Memorial Hospital Recruiting
Kasugai, Aichi, Japan, 487-0031
Aichi Medical University Hospital Recruiting
Nagakute, Aichi, Japan, 480-1195
Daido Clinic Recruiting
Nagoya, Aichi, Japan, 457-8511
Kamiiida daiichi General Hospital Recruiting
Nagoya, Aichi, Japan, 462-0802
Iizuka Hospital Recruiting
Iizuka, Fukuoka, Japan, 820-8505
Seishinkai Inoue Hospital Recruiting
Itoshima, Fukuoka, Japan, 819-1104
Fukuoka Tokushukai Medical Center Recruiting
Kasuga, Fukuoka, Japan, 816-0864
Kenwakai Otemachi Hospital Recruiting
Kitakyushu, Fukuoka, Japan, 803-8543
Fukuyama City Hospital Recruiting
Fukuyama, Hiroshima, Japan, 721-8511
Miyanomori Memorial Hospital Recruiting
Sapporo-shi, Hokkaido, Japan, 064-8570
Medical Corporation Tokushukai Koga General Hospital Recruiting
Koga, Ibaraki, Japan, 306-0041
Mito Kyodo General Hospital Recruiting
Mito, Ibaraki, Japan, 310-0015
Yokosuka Kyosai Hospital Recruiting
Yokosuka, Kanagawa, Japan, 238-8558
Osaki Citizen Hospital Recruiting
Osaki, Miyagi, Japan, 989-6183
Social Medical Care Corporation Hose-kai Marunouchi Hospital Recruiting
Matsumoto-City, Nagano Prefecture, Japan, 390-8601
Nozaki Tokushukai Hospital Recruiting
Daito, Osaka, Japan, 547-0074
Kusatsu General Hospital Recruiting
Kusatsu, Shiga, Japan, 525-8585
Yaizu City Hospital Recruiting
Yaizu, Shizuoka, Japan, 425-8505
Juntendo University Hospital Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Nerima General Hospital Recruiting
Nerima-ku, Tokyo, Japan, 176-8530
Sekino Hospital Recruiting
Toshima-ku, Tokyo, Japan, 171-0014
Fukui-Ken Saiseikai Hospital Recruiting
Fukui, Japan, 918-8503
Japanese Red Cross Kumamoto Hospital Recruiting
Kumamoto, Japan, 861-8520
Saga-Ken Medical Centre Koseikan Recruiting
Saga, Japan, 840-8571
Fukuwa Clinic Recruiting
Tokyo, Japan, 103-0027
Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan, Gyeonggi-do, Korea, Republic of, 15355
Asan Medical Center Recruiting
Songpa-gu, Seoul, Korea, Republic of, 05505
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
The Catholic University of Korea, St. Vincent's Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 16247
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 22332
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Hallym University Kangdong Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of, 05355
Hallym University Kangnam Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of, 07441
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Peru
Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A Recruiting
Trujillo, LA Libertad, Peru, 13011
Hospital Cayetano Heredia Recruiting
San Martin de Porres, Lima, Peru, 31
Hospital Nacional Adolfo Guevara Velasco Recruiting
Cusco, Peru, 08002
Clinica Internacional S.A Not yet recruiting
Lima, Peru, 41
Poland
NZOZ Vitamed Recruiting
Bydgoszcz, Poland, 85-079
Synexus Polska Sp. z o.o Oddzial w Gdansku Recruiting
Gdansk, Poland, 80-382
Synexus Polska Sp. z o.o. Oddzial w Gdyni Recruiting
Gdynia, Poland, 81-537
SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach Recruiting
Katowice, Poland, 40-040
Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C. Recruiting
Leczna, Poland, 21-010
Synexus Polska Sp. z o.o. Oddział w Poznaniu Recruiting
Poznan, Poland, 60-702
Synexus Polska Sp. z o.o. Oddzial w Warszawie Recruiting
Warszawa, Poland, 01-192
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu Recruiting
Wroclaw, Poland, 50-381
Portugal
Hospital Garcia de Orta Recruiting
Almada, Portugal, 2805-267
Centro Hospitalar do Baixo Vouga, E.P.E. Recruiting
Aveiro, Portugal, 3814-501
Hospital de Braga Recruiting
Braga, Portugal, 4710-243
Hospital Senhora de Oliveira - Guimaraes, E.P.E. Recruiting
Guimaraes, Portugal, 4835-044
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E. Recruiting
Vila Nova de Gaia, Portugal, 4434-502
Slovakia
PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia Recruiting
Bojnice, Slovakia, 972 01
Medak s.r.o., Gastroenterologicka ambulancia Active, not recruiting
Bratislava, Slovakia, 851 01
Stalerg, s.r.o. Recruiting
Kosice, Slovakia, 040 22
KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra Recruiting
Nitra, Slovakia, 949 01
Dionea, s.r.o. Recruiting
Nove Zamky, Slovakia, 940 01
MEDIPA, s.r.o. Vseobecna ambulancia pre dospelych Recruiting
Piestany, Slovakia, 921 01
MUDr. Viliam Cibik, PhD, s.r.o. Recruiting
Pruske, Slovakia, 01852
Medilex s.r.o., Interna ambulancia Recruiting
Rimavska Sobota, Slovakia, 979 01
Plucna ambulancia Hrebenar s.r.o. Recruiting
Spisska Nova Ves, Slovakia, 052 01
SPAOLO s.r.o., Ambulancia vnutorneho lekarstva Recruiting
Stara Tura, Slovakia, 916 01
Privatna urologicka ambulancia, s.r.o. Recruiting
Trencin, Slovakia, 911 01
MUDr. Zakova, s.r.o. Recruiting
Trencin, Slovakia, 91101
Fakutna nemocnica Trnava Recruiting
Trnava, Slovakia, 917 75
Spain
EAP Centelles Recruiting
Centelles, Barcelona, Spain, 08540
Hospital Universitari de Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Complejo Hospitalario Universitario A Coruna Recruiting
A Coruna, Spain, 15006
Parc de Salut Mar- Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08041
Hospital Universitario de la Princesa Recruiting
Madrid, Spain, 28006
Hospital General Universitario Gregorio Maranon Recruiting
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Hospital Universitari i Politecnic La Fe Recruiting
Valencia, Spain, 46026
Sweden
Infektionskliniken, Malarsjukhuset Recruiting
Eskilstuna, Sweden, 63188
Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset Recruiting
Goteborg, Sweden, 41650
Gothia Forum CTC/Sahlgrenska Universitetssjukhuset Recruiting
Göteborg, Sweden, 41345
Avdelningen for kliniska provningar, S-huset Recruiting
Orebro, Sweden, 70362
Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus Recruiting
Stockholm, Sweden, 11324
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung City, Taiwan (r.o.c.), Taiwan, 81362
Far Eastern Memorial Hospital Recruiting
New Taipei City, Taiwan, 220
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
United Kingdom
Stockport Nhs Foundation Trust Recruiting
Stockport, Cheshire, United Kingdom, SK27JE
Fowey River Practice Recruiting
Fowey, Cornwall, United Kingdom, PL23 1DT
Oak Tree Surgery Recruiting
Liskeard, Cornwall, United Kingdom, PL14 3XA
the Alverton Practice Recruiting
Penzance, Cornwall, United Kingdom, TR18 4JH
Rame Group Practice, Rame Medical Ltd. Recruiting
Torpoint, Cornwall, United Kingdom, PL11 2TB
Royal Devon & Exeter Hospital Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Knowle House Surgery Recruiting
Plymouth, Devon, United Kingdom, PL5 3JB
Layton Medical Centre Recruiting
Blackpool, Lancashire, United Kingdom, FY3 7EN
University Hospitals of Leicester NHS Trust Recruiting
Leicester, Leicestershire, United Kingdom, LE1 5WW
NHS Lothian, Western General Hospital Recruiting
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Heart of England NHS Foundation Trust Recruiting
Birmingham, WEST Midlands, United Kingdom, B9 5SS
Old Medical School Recruiting
Leeds, United Kingdom, LS1 3EX
Newcastle upon Tyne Hospitals NHS Foundation trust Recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03090191     History of Changes
Other Study ID Numbers: B5091007
2016-003866-14 ( EudraCT Number )
CLOVER ( Other Identifier: Alias Study Number )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs