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
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:
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:
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
Aurora, Colorado 80045, United States
Aurora, Colorado 80045, United States
Aurora, Colorado 80045, United States
Aurora, Colorado 80045, United States
Gainesville, Florida 32608, United States
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Durham, North Carolina 27710, United States
Tabor City, North Carolina 28463, United States
Cincinnati, Ohio 45267, United States
Allentown, Pennsylvania 18103, United States
San Antonio, Texas 78229, United States
Annandale, Virginia 22003, United States
C.a.b.a., Buenos Aires C1118AAT, Argentina
C.a.b.a., Buenos Aires C1199ABB, Argentina
C.a.b.a., Buenos Aires C1426ABP, Argentina
Maroiubra, New South Wales 2035, Australia
South Brisbane, Queensland 4101, Australia
Pleven, 5800, Bulgaria
Vancouver, British Columbia V5Z1M9, Canada
Greenfield Park, Quebec J4V 2H1, Canada
Trois-Rivières, Quebec G8Z 3R9, Canada
Bogotá, D.C. 110221, Colombia
Pribram I., 26101, Czechia
Budapest, 1097, Hungary
Bunkyo-ku, Tokyo 113-8431, Japan
Chuo-ku, Tokyo 104-0031, Japan
Nerima-ku, Tokyo 176-8530, Japan
Toshima-ku, Tokyo 171-0014, Japan
Trujillo, La Libertad, 13011, Peru
Nitra, 949 01, Slovakia
Songpa-gu, Seoul 05505, South Korea