A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
NCT ID: NCT02561195
Last Updated: 2021-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2015-07-16
2020-02-13
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
PREVENTION
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
* Aged 65 to 85 years
* Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study.
Exclusion Criteria
* 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
* Subjects originally randomized to placebo during the original portion of the study.
* Subjects who have already completed Visit 9 prior to study unblinding.
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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Avail Clinical Research, LLC
DeLand, Florida, United States
QPS-MRA, LLC (Broward Research Group)
Hollywood, Florida, United States
QPS-MRA, LLC (Miami Research Associates)
South Miami, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States
Vince & Associates Clinical Research, Inc
Overland Park, Kansas, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Clinical Research Center of Nevada LLC
Las Vegas, Nevada, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Benchmark Research
Austin, Texas, United States
Texas Center For Drug Development, Inc.
Houston, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Countries
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References
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Remich S, Kitchin N, Peterson J, Li P, Pride MW, Brock L, Anderson AS, Gruber WC, Jansen KU, Lockhart SP, Webber C. A Phase 2 Extension Study Evaluating the Immunogenicity, Safety, and Tolerability of 3 or 4 Doses of a Clostridioides difficile Vaccine in Healthy US Adults Aged 65 to 85 Years. J Infect Dis. 2024 Feb 14;229(2):367-375. doi: 10.1093/infdis/jiad307.
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B5091009
Identifier Type: -
Identifier Source: org_study_id
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