Clostridium Difficile Vaccine Efficacy Trial



Status:Recruiting
Healthy:No
Age Range:50 - Any
Updated:3/1/2019
Start Date:March 29, 2017
End Date:September 28, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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

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.


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
We found this trial at
217
sites
Dayton, Ohio 45419
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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DeLand, FL
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910 Oakfield Dr # 102
Brandon, Florida 33511
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304 Northeast 1st Street
Chiefland, Florida 32626
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Galveston, TX
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5615 Kirby Dr.
Houston, Texas 77005
713-442-1223
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303 Williams Ave
Huntsville, Alabama 35801
256-533-6603
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3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
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2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Albuquerque, New Mexico 87108
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Allentown, Pennsylvania 18105
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Anderson, Indiana 46011
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Ann Arbor, Michigan 48113
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2002 Medical Parkway
Annapolis, Maryland 21401
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Annapolis, Maryland 21401
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Athens, Alabama 35811
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Austin, Texas 78745
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600 North Highland Springs Avenue
Banning, California 92220
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Bardstown, Kentucky 40004
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Bay Pines, Florida 33744
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3800 Houma Boulevard
Biloxi, Mississippi 39531
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Binghamton, New York 13901
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Brandon, Florida 33511
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Bristol, Tennessee 37620
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Bristol, Tennessee 37620
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Butte, Montana 59701
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C.a.b.a., Buenos Aires
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Camp Hill, Pennsylvania 17011
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24 Frank Lloyd Wright Drive
Canton, Michigan 48187
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Canton, Ohio 44710
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Carmel, Indiana 46032
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Cary, North Carolina 27518
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5000 Centregreen Way
Cary, North Carolina 27513
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Champaign, Illinois 61820
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28209
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Chicago, Illinois 60656
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Cincinnati, Ohio 45219
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222 Piedmont Avenue
Cincinnati, Ohio 45219
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Clearwater, Florida 33756
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Cleveland, Ohio 44122
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Columbus, Ohio 43215
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801 Monterey Street
Coral Gables, Florida 33134
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2020 Ponce de Leon Boulevard
Coral Gables, Florida 33134
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Dakota Dunes, South Dakota 57049
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Dallas, Texas 75324
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395 Hickey Boulevard
Daly City, California 94015
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Decatur, Georgia 30033
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Downey, California 90241
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Durham, North Carolina 27705
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2400 Pratt Street
Durham, North Carolina 27710
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Endwell, New York 13760
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Erie, Pennsylvania 16506
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Erie, Pennsylvania 16508
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Evansville, Indiana 47725
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Fargo, North Dakota 58103
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Fleming Island, Florida 32003
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1201 Flushing Road
Flint, Michigan 48504
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Fort Worth, Texas 76104
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Gainesville, Florida 32608
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Greensboro, North Carolina 27408
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Hamden, Connecticut 06518
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Hialeah, Florida 33012
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Hickory, North Carolina 28602
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Hillsborough, New Jersey 08844
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Hines, Illinois 60141
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Honolulu, Hawaii 96814
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Houston, Texas 77025
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Idaho Falls, Idaho 83404
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32216
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