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Trial record 1 of 1 for:    B5091007
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Clostridium Difficile Vaccine Efficacy Trial (Clover)

This study is currently recruiting participants.
Verified November 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT03090191
First Posted: March 24, 2017
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose

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 Intervention Phase
Clostridium Difficile Infection Biological: Clostridium difficile vaccine Biological: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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)

  • 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)

  • 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

  • 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

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

  • 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:
  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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

  • 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

  • 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


Estimated Enrollment: 15776
Actual Study Start Date: March 29, 2017
Estimated Study Completion Date: September 28, 2020
Estimated Primary Completion Date: September 28, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
  Contacts and Locations
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

  Hide Study Locations
Locations
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
United States, Arizona
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
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
United States, Arkansas
Baptist Health Center for Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
Arkansas Gastroenterology Recruiting
North Little Rock, Arkansas, United States, 72117
United States, California
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 Not yet 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) Not yet recruiting
Los Angeles, California, United States, 90095
Ronald Reagan UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
UCLA CTRC Outpatient Unit Not yet recruiting
Los Angeles, California, United States, 90095
VA Northern California Health Care System Not yet 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 Not yet 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
Kaiser Permanente Roseville Recruiting
Roseville, California, United States, 95661
Kaiser Permanente Sacramento Recruiting
Sacramento, California, United States, 95815
University Of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Kaiser Permanente South Sacramento Recruiting
Sacramento, California, United States, 95823
Paradigm Clinical Research Centers, Inc. Recruiting
San Diego, California, United States, 92117
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
California Kidney Specialists Recruiting
San Dimas, California, United States, 91773
Kaiser Permanente San Jose Recruiting
San Jose, California, United States, 95119
Kaiser Permanente Santa Clara Recruiting
Santa Clara, California, United States, 95051
Alta California Medical Group Recruiting
Simi Valley, California, United States, 93065
Kaiser Permanente Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
United States, Colorado
University of Colorado Denver, School of Medicine Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Clinical Research Consulting, LLC Recruiting
Milford, Connecticut, United States, 06460
United States, Florida
Bay Pines VA Healthcare System Recruiting
Bay Pines, Florida, United States, 33744
PAB Clinical Research Recruiting
Brandon, Florida, United States, 33511
Pulmonary Associates of Brandon Recruiting
Brandon, Florida, United States, 33511
Southeast Clinical Research Recruiting
Chiefland, Florida, United States, 32626
Innovative Research of West FL., Inc. Recruiting
Clearwater, Florida, United States, 33756
Clinical Research of South Florida Recruiting
Coral Gables, Florida, United States, 33134
Avail Clinical Research, LLC Recruiting
DeLand, Florida, United States, 32720
Fleming Island Center for Clinical Research Recruiting
Fleming Island, Florida, United States, 32003
Malcom Randall VA Medical Center Investigational Drug Services (IP Shipment Address Only) Not yet recruiting
Gainesville, Florida, United States, 32608
Malcom Randall VA Medical Center Not yet recruiting
Gainesville, Florida, United States, 32608
Precision Clinical Research, LLC Recruiting
Lauderdale Lakes, Florida, United States, 33319
Ocean Blue Medical Research Center, Inc. Recruiting
Miami Springs, Florida, United States, 33166
Finlay Medical Research Recruiting
Miami, Florida, United States, 33126
Acevedo Clinical Research Associates Recruiting
Miami, Florida, United States, 33142
Next Phase Research Alliance Recruiting
Miami, Florida, United States, 33144
Doctors Research Institute Recruiting
Miami, Florida, United States, 33145
Naples Research Recruiting
Naples, Florida, United States, 34102
Clinical Neuroscience Solutions, Inc Recruiting
Orlando, Florida, United States, 32801
Omega Research Consultants, LLC Not yet recruiting
Orlando, Florida, United States, 32810
HMD Research LLC Recruiting
Orlando, Florida, United States, 32819
Pines Care Research Center Recruiting
Pembroke Pines, Florida, United States, 33026
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Soma Medical Center Recruiting
West Palm Beach, Florida, United States, 33406
Southeast Clinical Research at Palms Medical Group Recruiting
Williston, Florida, United States, 32696
United States, Georgia
Atlanta VA Medical Center Recruiting
Decatur, Georgia, United States, 30033
Meridian Clinical Research, LLC Recruiting
Savannah, Georgia, United States, 31406
Clinical Research Atlanta Recruiting
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute Recruiting
Honolulu, Hawaii, United States, 96814
United States, Idaho
Snake River Research, PLLC Recruiting
Idaho Falls, Idaho, United States, 83404
Advanced Clinical Research Recruiting
Meridian, Idaho, United States, 83642
Solaris Clinical Research Recruiting
Meridian, Idaho, United States, 83646
United States, Illinois
PMG Research of Christie Clinic, LLC Recruiting
Champaign, Illinois, United States, 61822
Edward Hines Jr VA Hospital Not yet recruiting
Hines, Illinois, United States, 60141
Springfield Clinic Infectious Diseases Recruiting
Springfield, Illinois, United States, 62702
Springfield Clinic, Clinical Research Department Recruiting
Springfield, Illinois, United States, 62703
United States, Indiana
Community Clinical Research Center Recruiting
Anderson, Indiana, United States, 46011
Deaconess Clinic Mt. Pleasant Not yet recruiting
Evansville, Indiana, United States, 47725
MOC Research Recruiting
Mishawaka, Indiana, United States, 46544
United States, Kansas
Heartland Research Associates, LLC Recruiting
Wichita, Kansas, United States, 67205
United States, Kentucky
Kentucky Pediatric/Adult Research Recruiting
Bardstown, Kentucky, United States, 40004
Central Kentucky Research Associates, LLC Recruiting
Lexington, Kentucky, United States, 40509
United States, Louisiana
MedPharmics, LLC Recruiting
Metairie, Louisiana, United States, 70006
KAMP Medical Research, Inc. Recruiting
Natchitoches, Louisiana, United States, 71457
Ochsner Center for Primary Care and Wellness Recruiting
New Orleans, Louisiana, United States, 70121
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maryland
Anne Arundel Health System Research Institute Not yet recruiting
Annapolis, Maryland, United States, 21401
Anne Arundel Medical Center Infusion Center Not yet recruiting
Annapolis, Maryland, United States, 21401
Anne Arundel Medical Center Research Pharmacy Not yet recruiting
Annapolis, Maryland, United States, 21401
Anne Arundel Medical Center Not yet recruiting
Annapolis, Maryland, United States, 21401
United States, Michigan
VA Ann Arbor Healthcare System Not yet recruiting
Ann Arbor, Michigan, United States, 48105
ClinSite, LLC Recruiting
Ann Arbor, Michigan, United States, 48106
Aa Mrc Llc Recruiting
Flint, Michigan, United States, 48504
Revival Research Institute, LLC Recruiting
Sterling Heights, Michigan, United States, 48313
United States, Minnesota
Mayo Clinic, Methodist Hospital Campus (Drug Shipments Only) Recruiting
Rochester, Minnesota, United States, 55902
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Mississippi
MedPharmics, LLC Recruiting
Biloxi, Mississippi, United States, 39531
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110-1093
Barnes Jewish Hospital Not yet recruiting
Saint Louis, Missouri, United States, 63110
Barnes-Jewish Hospital Not yet recruiting
Saint Louis, Missouri, United States, 63110
Center for Advanced Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Center For Clinical Studies Not yet recruiting
Saint Louis, Missouri, United States, 63110
Sundance Clinical Research Recruiting
Saint Louis, Missouri, United States, 63141
United States, Montana
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
United States, Nebraska
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
United States, New Jersey
ID Care Recruiting
Hillsborough, New Jersey, United States, 08844
South Jersey Infectious Disease Recruiting
Somers Point, New Jersey, United States, 08244
Amici Clinical Research Not yet recruiting
Warren, New Jersey, United States, 07059
United States, New Mexico
New Mexico VA Healthcare System (Drug Ship Address) Not yet recruiting
Albuquerque, New Mexico, United States, 87108
New Mexico VA Healthcare System Not yet recruiting
Albuquerque, New Mexico, United States, 87108
United States, New York
United Medical Associates Recruiting
Binghamton, New York, United States, 13901
Regional Clinical Research, Inc. Recruiting
Endwell, New York, United States, 13760
Northern Westchester Hospital Not yet recruiting
Mount Kisco, New York, United States, 10549
Parker Jewish Institute for Health Care & Rehabilitation Not yet recruiting
New Hyde Park, New York, United States, 11040
Rochester Clinical Research Recruiting
Rochester, New York, United States, 14609
United States, North Carolina
Waterway Primary Care LLC dba Calabash Medical Center Recruiting
Calabash, North Carolina, United States, 28467
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
United States, North Dakota
Lillestol Research LLC Recruiting
Fargo, North Dakota, United States, 58103
United States, Ohio
Aultman Cardiology Clinical Trials Recruiting
Canton, Ohio, United States, 44710
Sterling Research Group, Ltd. Recruiting
Cincinnati, Ohio, United States, 45246
Louis Stokes Cleveland VA Medical Center Recruiting
Cleveland, Ohio, United States, 44106
PriMed Clinical Research Recruiting
Dayton, Ohio, United States, 45419
Great Lakes Medical Research Recruiting
Mentor, Ohio, United States, 44060
United States, Oklahoma
IPS Research Company Active, not recruiting
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
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
United States, Pennsylvania
Lehigh Valley Health Network/Network Office of Research and Innovation Recruiting
Allentown, Pennsylvania, United States, 18103
Capital Area Research, LLC Recruiting
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 Not yet 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
United States, Rhode Island
Omega Medical Research Recruiting
Warwick, Rhode Island, United States, 02886
United States, South Carolina
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
University of Tennessee Medical Center Not yet recruiting
Knoxville, Tennessee, United States, 37920
PMG Research,Inc. d/b/a PMG Research of Knoxville Recruiting
Knoxville, Tennessee, United States, 37938
Trinity Clinical Research Recruiting
Tullahoma, Tennessee, United States, 37388
United States, Texas
Tekton Research, Inc. Recruiting
Austin, Texas, United States, 78745
Research Across America Recruiting
Dallas, Texas, United States, 75234
Ventavia Research Group, LLC Recruiting
Fort Worth, Texas, United States, 76104
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 Not yet 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 Not yet recruiting
Salem, Virginia, United States, 24153
United States, Washington
Frandsen Family Medicine DBA Sound Medical Research Recruiting
Port Orchard, Washington, United States, 98366
Multicare Health System Recruiting
Tacoma, Washington, United States, 98405
Wenatchee Valley Hospital & Clinics Recruiting
Wenatchee, Washington, United States, 98801
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
Mingara Medical Pty Ltd Not yet recruiting
Tumbi Umbi, New South Wales, Australia, 2261
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
Barwon Health Recruiting
Geelong, Victoria, Australia, 3220
Emeritus Research Recruiting
Malvern East, Victoria, Australia, 3145
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
Belgium
Universiteit Antwerpen - Campus Drie Eiken Not yet recruiting
Antwerpen, Belgium, 2610
Institut Jules Bordet Not yet recruiting
Brussels, Belgium, 1000
UZ Leuven Recruiting
Leuven, Belgium, 3000
CHU de Liège - Domaine universitaire du Sart Tilman Not yet recruiting
Liege, Belgium, 4000
ResearchLink Not yet recruiting
Linkebeek, Belgium, 1630
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 Not yet recruiting
Silistra, Bulgaria, 7500
MC ''Tsaritsa Yoanna''EOOD Not yet 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 Not yet recruiting
Vidin, Bulgaria, 3700
Canada, British Columbia
The Medical Arts Health Research Group Not yet recruiting
Kamloops, British Columbia, Canada, V2C 5T1
Canada, Ontario
Manna Research Inc. (Toronto) Recruiting
Toronto, Ontario, Canada, M9W4L6
Canada, Quebec
Q & T Research Chicoutimi Recruiting
Chicoutimi, Quebec, Canada, G7H 7Y8
Q & T Recherche Outaouais Inc. Not yet recruiting
Gatineau, Quebec, Canada, J8Y 6S8
CIUSSS de l'Estrie - CHUS Not yet recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Canada
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 Not yet recruiting
Temuco, Region DE LA Araucania, Chile, 4781156
Hospital Dr. Hernan Henriquez Aravena Not yet recruiting
Temuco, Region DE LA Araucaria, Chile, 4781151
Biomedica Research Group Recruiting
Santiago, Región Metropolitana, Chile, 7500710
Fundacion Arriaran Not yet recruiting
Santiago, Región Metropolitana, Chile, 8360159
Psicomed Esudios Medicos Not yet recruiting
Antofagasta, Segunda Region, Chile, 1270244
Centro de Investigaciones Clinicas Viña del Mar Ltda. Not yet recruiting
Vina del Mar, Valparaíso, Chile, 25240364
Colombia
Fundacion Centro de Investigacion Clinica - CIC Not yet recruiting
Medellin, Antioquia, Colombia, 050021
Clinica de la Costa Ltda. Not yet recruiting
Barranquilla, Atlantico, Colombia, 080020
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 Not yet recruiting
Benatky nad Jizerou, Czechia, 29471
Slezska Nemocnice v Opave, prispevkova organizace Not yet 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 Not yet recruiting
Praha 5, Czechia, 150 06
Oblastni nemocnice Pribram, a.s. Not yet recruiting
Pribram I., Czechia, 26101
Interna a kardiologie s.r.o. Not yet recruiting
Roznov pod Radhostem, Czechia, 756 61
Nemocnice Slany Not yet recruiting
Slany, Czechia, 274 01
Sarkamed s.r.o. Recruiting
Slany, Czechia, 27401
Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem o.z. Not yet 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 Not yet recruiting
Dijon cedex, France, 21079
CIC Vaccinologie Cochin- Pasteur 1417 Not yet recruiting
Paris, France, 75014
CHU Reims-Robert Debre-Servicemedecine interne Not yet recruiting
Reims Cedex, France, 51092
Hopital Nord-CHU Saint Etienne Not yet recruiting
Saint Priest en Jarez, France, 42270
CHRU de Tours- Hopital Bretonneau Not yet recruiting
Tours Cedex 09, France, 37044
Germany
Emovis GmbH Recruiting
Berlin, Germany, 10629
MECS Cottbus GmbH Recruiting
Cottbus, Germany, 03050
Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann Not yet recruiting
Dresden, Germany, 01279
Universitaetsklinikum Essen, Klinik fuer Infektiologie Recruiting
Essen, Germany, 45147
Klinik I fuer Innere Medizin , Universitaetsklinikum Koeln Not yet recruiting
Koeln, Germany, 50937
EUGASTRO GmbH/ Praxis Not yet recruiting
Leipzig, Germany, 04103
SIBAmed Studienzentrum GmbH & Co.KG Recruiting
Leipzig, Germany, 04103
Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut Not yet recruiting
Leipzig, Germany, 04249
Universitaetsmedizin Rostock Not yet recruiting
Rostock, Germany, 18057
MALU medizinische Studien GmbH Recruiting
Wardenburg, Germany, 26203
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 Recruiting
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
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Infektologia Osztaly Not yet recruiting
Szekesfehervar, Hungary, 8000
Japan
Tokai Memorial Hospital Recruiting
Kasugai, Aichi, Japan, 487-0031
Aichi Medical University Hospital Not yet 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 Not yet 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 Not yet recruiting
Sapporo-shi, Hokkaido, Japan, 064-8570
Mito Kyodo General Hospital Recruiting
Mito, Ibaraki, Japan, 310-0015
Osaki Citizun Hospital Recruiting
Osaki, Miyagi, Japan, 989-6183
Marunouchi Hospital Recruiting
Matsumoto, Nagano, Japan, 390-8601
Nozaki Tokushukai Hospital Recruiting
Daito, Osaka, Japan, 547-0074
Kusatsu General Hospital Recruiting
Kusatsu, Shiga, Japan, 525-8585
Yaizu City Hospital Not yet recruiting
Yaizu, Shizuoka, Japan, 425-8505
Nerima General Hospital Recruiting
Nerima-ku, Tokyo, Japan, 176-8530
Sekino Hospital Recruiting
Toshima-ku, Tokyo, Japan, 171-0014
Fukui-Ken Saiseikai Hospital Not yet 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 Not yet recruiting
Ansan, Gyeonggi-do, Korea, Republic of, 15355
Asan Medical Center Not yet recruiting
Songpa-gu, Seoul, Korea, Republic of, 05505
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
The Catholic University of Korea, St. Vincent's Hospital Not yet recruiting
Gyeonggi-do, Korea, Republic of, 16247
Inha University Hospital Not yet recruiting
Incheon, Korea, Republic of, 22332
Korea University Anam Hospital Not yet recruiting
Seoul, Korea, Republic of, 02841
Hallym University Kangdong Sacred Heart Hospital Not yet 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 Not yet recruiting
Trujillo, LA Libertad, Peru, 13011
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, 81-384
SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach Recruiting
Katowice, Poland, 40-040
SP ZOZ Szpital Uniwersytecki w Krakowie Not yet recruiting
Krakow, Poland, 31-531
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
NZLA Michalkowice Not yet recruiting
Siemianowice Slaskie, Poland, 41-103
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 Not yet 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. Not yet 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 Not yet recruiting
Bratislava, Slovakia, 851 01
Stalerg, s.r.o. Not yet 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
Privatna urologicka ambulancia, s.r.o. Recruiting
Trencin, Slovakia, 911 01
MUDr. Zakova, s.r.o. Recruiting
Trencin, Slovakia, 91101
Fakultna nemocnica Trnava Not yet 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 Not yet recruiting
Barcelona, Spain, 08041
Hospital Universitario de la Princesa Recruiting
Madrid, Spain, 28006
Hospital General Universitario Gregorio Maranon Not yet recruiting
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal Not yet 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
Gothia Forum CTC/Sahlgrenska Universitetssjukhuset Not yet recruiting
Göteborg, Sweden, 41345
Sahlgrenska Universitetssjukhuset- Östra Sjukhuset Recruiting
Göteborg, Sweden, 41650
PharmaSite Not yet recruiting
Malmo, Sweden, 211 52
Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus Not yet recruiting
Stockholm, Sweden, 11324
Primary Trial Care Center, PTC Not yet recruiting
Västra Frölunda, Sweden, 42144
Avdelningen för klinisk prövningar, S-huset Not yet recruiting
Örebro, Sweden, 70362
Taiwan
Kaohsiung Veterans General Hospital Not yet recruiting
Kaohsiung City, Taiwan (r.o.c.), Taiwan, 81362
Far Eastern Memorial Hospital Not yet recruiting
New Taipei City, Taiwan, 220
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 10002
United Kingdom
Stockport Nhs Foundation Trust Not yet recruiting
Stockport, Cheshire, United Kingdom, SK27JE
Fowey River Practice Not yet recruiting
Fowey, Cornwall, United Kingdom, PL23 1DT
Oak Tree Surgery Recruiting
Liskeard, Cornwall, United Kingdom, PL14 3XA
the Alverton Practice Not yet recruiting
Penzance, Cornwall, United Kingdom, TR18 4JH
Rame Group Practice, Rame Medical Ltd. Recruiting
Torpoint, Cornwall, United Kingdom, PL11 2TB
Royal Devon & Exeter Hospital Not yet 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
Blackpool Teaching Hospitals NHS Foundation Trust Not yet recruiting
Blackpool, Lancashire, United Kingdom, FY3 8NR
University Hospitals of Leicester NHS Trust Not yet 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 Not yet recruiting
Birmingham, WEST Midlands, United Kingdom, B9 5SS
Old Medical School Recruiting
Leeds, United Kingdom, LS1 3EX
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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 Submitted: March 20, 2017
First Posted: March 24, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017
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