A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
NCT02561195
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Healthy male and female subjects
- Aged 65 to 85 years
Additional Inclusion Criteria for the extension Stage:
- Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study.
- Proven or suspected prior episode of Clostridium difficile associated diarrhea
- Unstable chronic medical condition
- Disease requiring significant change in therapy or hospitalization for worsening
disease within 8 weeks before receipt of study vaccine
- Serious chronic disorders
- Congenital or acquired immunodeficiency disorders
- Rheumatologic disorders or other illnesses requiring chronic treatment with known
immunosuppressant medications.
- Active or treated leukemia or lymphoma or bone marrow disorder
- Any contraindication to vaccination or vaccine components including previous
anaphylactic reaction to any vaccine or vaccine-related components
Additional Exclusion Criteria for the Extension Stage:
- Subjects originally randomized to placebo during the original portion of the study.
- Subjects who have already completed Visit 9 prior to study unblinding.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years | ||||||
Official Title ICMJE | A PHASE 2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TWO 3-DOSE REGIMENS OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS AGED 65 TO 85 YEARS | ||||||
Brief Summary | This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules. The study will assess the safety and tolerability of the vaccine as well as the subjects' immune response to the vaccine. One year after the third dose subjects that did not receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up to 4 years after their third vaccination. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
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 * | Kitchin N, Remich SA, Peterson J, Peng Y, Gruber WC, Jansen KU, Pride MW, Anderson AS, Knirsch C, Webber C. A Phase 2 Study Evaluating the Safety, Tolerability, and Immunogenicity of Two 3-Dose Regimens of a Clostridium difficile Vaccine in Healthy US Adults Aged 65 to 85 Years. Clin Infect Dis. 2020 Jan 1;70(1):1-10. doi: 10.1093/cid/ciz153. | ||||||
* 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 | 944 | ||||||
Original Estimated Enrollment ICMJE | 854 | ||||||
Actual Study Completion Date ICMJE | February 13, 2020 | ||||||
Actual Primary Completion Date | March 7, 2017 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Additional Inclusion Criteria for the extension Stage:
Exclusion Criteria:
Additional Exclusion Criteria for the Extension Stage:
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Sex/Gender ICMJE |
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Ages ICMJE | 65 Years to 85 Years (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 | NCT02561195 | ||||||
Other Study ID Numbers ICMJE | B5091009 | ||||||
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 | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |