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 |
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.
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
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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University of Cincinnati Medical Center Opening in 1823 as the country
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Allentown, Pennsylvania 18102
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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
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120 North 19th Avenue
Bozeman, Montana 59718
Bozeman, Montana 59718
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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