Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
NCT03918629
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- 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.
- 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 <15 mL/min/1.73 m2 or on
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
therapy.
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study | ||||||
Official Title ICMJE | A PHASE 3, RANDOMIZED OBSERVER-BLINDED STUDY TO EVALUATE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF 2 DOSES COMPARED TO 3 DOSES OF CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER | ||||||
Brief Summary | This study will investigate a Clostridium difficile vaccine in healthy adults 50 years of age and older. In half the healthy adults, all 3 doses given are the Clostridium difficile vaccine, and in half the healthy adults, 2 of the 3 doses are the Clostridium difficile vaccine with the other dose containing no active ingredients. The study will look at the subjects' immune response to the vaccine and assess the safety and tolerability of a 2-dose regimen of Clostridium difficile vaccine compared to a 3-dose regimen of Clostridium difficile vaccine. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Prevention | ||||||
Condition ICMJE | Clostridium Difficile Associated Disease | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 1998 | ||||||
Original Estimated Enrollment ICMJE | 500 | ||||||
Actual Study Completion Date ICMJE | December 17, 2020 | ||||||
Actual Primary Completion Date | December 17, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03918629 | ||||||
Other Study ID Numbers ICMJE | B5091019 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |