Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
NCT02725437
ABOUT THIS STUDY
FOR MORE INFORMATION
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1. Healthy male and female adults
2. Aged 65 to 85 years
1. Proven or suspected prior episode of Clostridium difficile associated diarrhea
2. Unstable chronic medical condition
3. Disease requiring significant change in therapy or hospitalization for worsening
disease within 8 weeks before receipt of study vaccine
4. Serious chronic medical disorders
5. Bleeding diathesis or condition associated with prolonged bleeding time that may
contraindicate intramuscular injection
6. Any contraindication to vaccination or vaccine components, including previous
anaphylactic reaction to any vaccine or vaccine-related components
7. Subjects with congenital or acquired immunodeficiency disorders
8. Subjects with rheumatologic disorders or other illnesses requiring chronic treatment
with known immunosuppressant medications
9. Active or treated leukemia or lymphoma or bone marrow disorder
10. Residence in a nursing home or other long-term care facility, or requirement for
semiskilled nursing care or assisted living
11. Abnormality in screening hematology and/or blood chemistry laboratory values
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Descriptive Information | ||||
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Brief Title ICMJE | Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults | |||
Official Title ICMJE | A Phase 1, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Two 3-dose Regimens Of Clostridium Difficile Vaccine Administered In Healthy Japanese Adults Aged 65 To 85 Years. | |||
Brief Summary | The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Other | |||
Condition ICMJE | Clostridium Difficile Associated Disease | |||
Intervention ICMJE |
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Study Arms ICMJE |
| |||
Publications * | Inoue M, Yonemura T, de Solom R, Yamaji M, Aizawa M, Knirsch C, Pride MW, Jansen KU, Gruber W, Webber C. A phase 1 randomized study assessing safety and immunogenicity of two 3-dose regimens of a Clostridium difficile vaccine in healthy older Japanese adults. Vaccine. 2019 May 1;37(19):2600-2607. doi: 10.1016/j.vaccine.2019.03.014. Epub 2019 Apr 5. | |||
* 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 | 100 | |||
Original Estimated Enrollment ICMJE | 128 | |||
Actual Study Completion Date ICMJE | February 2017 | |||
Actual Primary Completion Date | February 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02725437 | |||
Other Study ID Numbers ICMJE | B5091010 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |