Trial Search Results

Clostridium Difficile Vaccine Efficacy Trial

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pfizer

Stanford Investigator(s):

Intervention(s):

  • Biological: Clostridium difficile vaccine
  • Biological: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

50 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mark Holodniy
650-493-5000
Not Recruiting