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Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study

Last updated on July 25, 2019

Study Location
Hope Research Institute
Phoenix, Arizona, 85018 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Clostridium Difficile Associated Disease
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Pregnant female participants; breastfeeding female participants; positive urine
pregnancy test for women of childbearing potential (WOCBP); and WOCBP who are, in the
opinion of the investigator, sexually active and at risk for pregnancy and are
unwilling or unable to use effective methods of contraception as outlined in this
protocol from the signing of the informed consent until at least 28 days after the
last dose of investigational product.

- Prior episode of CDI, confirmed by either laboratory test or diagnosis of
pseudomembranous colitis at colonoscopy, at surgery, or histopathologically.

- Participants who may be unable to respond to vaccination due to:

- Metastatic malignancy; or

- End-stage renal disease (glomerular filtration rate dialysis).

- Any serious medical disorder that in the investigator's opinion is likely to be
fatal within the next 12 months.

- Congenital or acquired immunodeficiency.

- Known infection with human immunodeficiency virus (HIV).

- Any bleeding disorder or anticoagulant therapy that would contraindicate IM injection.

- Any contraindication to vaccination or vaccine components, including previous
anaphylactic reaction to any vaccine or vaccine-related components.

- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.

- Previous administration of an investigational C difficile vaccine or C difficile mAb

- Receipt of systemic corticosteroids for greater than or equal to 14 days within 28
days before enrollment.

- Receipt of chronic systemic treatment with other known immunosuppressant medications,
or radiotherapy, within 6 months before enrollment.

- Receipt of blood products or immunoglobulins within 6 months before enrollment.

- Participation in other studies involving investigational drug(s)/vaccine(s) within 28
days prior to study entry until 1 month after the third vaccination.

- 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
Pfizer employees, including their family members, directly involved in the conduct of
the study.

Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study


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