Clostridium Difficile Vaccine Efficacy Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Clostridium Difficile Infection

In brief

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.

Key facts

Study ID

NCT03090191

Run by

Pfizer

People needed

17535

Starts

2017-03-29

Expected to finish

2021-12-21

Last updated by the study team

2023-02-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States
• Coastal Clinical Research, LLC, An AMR Company — Mobile, Alabama, United States
• The Pain Center of Arizona — Peoria, Arizona, United States
• Phoenix VA Health Care System — Phoenix, Arizona, United States
• Phoenix Clinical LLC — Phoenix, Arizona, United States
• MedPharmics, LLC — Phoenix, Arizona, United States
• Hope Research Institute — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• Clinical Research Institute of Arizona, LLC — Surprise, Arizona, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Baptist Health Rehabilitation Institute — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• California Kidney Specialist — Covina, California, United States
• Usborne Family Medicine — Covina, California, United States
• Kaiser Permanente Daly City — Daly City, California, United States
• Premier Health Research Center, LLC — Downey, California, United States
• Paradigm Clinical Research Centers, Inc. — La Mesa, California, United States
• VA Loma Linda Healthcare System Research Pharmacy — Loma Linda, California, United States
• VA Loma Linda Healthcare System — Loma Linda, California, United States
• Long Beach Clinical Trials Services, Inc. — Long Beach, California, United States
• Long Beach Clinical Trials — Long Beach, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• North Alabama Research Center, LLC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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