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A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

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NCT02561195

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Avail Clinical Research, LLC
DeLand, Florida, 32720 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Clostridium Difficile Associated Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02561195
Pfizer
Active, not recruiting
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Clostridium Difficile Associated Disease
  • Biological: Clostridium difficile Vaccine
    0.5 mL intramuscular injection.
  • Biological: Placebo
    0.5 mL intramuscular injection
  • Experimental: Low-dose C. difficile Vaccine (accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Experimental: High-dose C. difficile Vaccine (accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Placebo Comparator: Placebo (accelerated schedule)
    Intervention: Biological: Placebo
  • Experimental: Low-dose C. difficile Vaccine (non-accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Experimental: High-Dose C. difficile Vaccine (non-accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Placebo Comparator: Placebo (non-accelerated schedule)
    Intervention: Biological: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
847
April 2020
March 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
65 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02561195
B5091009
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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