Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
NCT ID: NCT02725437
Last Updated: 2018-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
100 participants
INTERVENTIONAL
2016-02-29
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Low-dose C. difficile Vaccine (accelerated schedule)
Clostridium difficile Vaccine
0.5 mL intramuscular injection
High-dose C. difficile Vaccine (accelerated schedule)
Clostridium difficile Vaccine
0.5 mL intramuscular injection
Placebo (accelerated schedule)
Placebo
0.5 mL intramuscular injection
Low-dose C. difficile Vaccine (non-accelerated schedule)
Clostridium difficile Vaccine
0.5 mL intramuscular injection
High-dose C. difficile Vaccine (non-accelerated schedule)
Clostridium difficile Vaccine
0.5 mL intramuscular injection
Placebo (non-accelerated schedule)
Placebo
0.5 mL intramuscular injection
Interventions
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Clostridium difficile Vaccine
0.5 mL intramuscular injection
Placebo
0.5 mL intramuscular injection
Eligibility Criteria
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Inclusion Criteria
2. Aged 65 to 85 years
Exclusion Criteria
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
65 Years
85 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
Sumida-ku, Tokyo, Japan
SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)
Fukuoka, , Japan
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
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Other Identifiers
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B5091010
Identifier Type: -
Identifier Source: org_study_id
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