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A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

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NCT02117570

Last updated on December 14, 2017
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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
50-85 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 50 to 85 years

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 or disease requiring significant change in therapy or
hospitalization for worsening disease within 8 weeks before receipt of study vaccine.

Any contraindication to vaccination or vaccine components, including previous anaphylactic
reaction to any vaccine or vaccine-related components.

NCT02117570
Pfizer
Completed
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

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A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
A Phase 2, Placebo-controlled, Randomised, Observer-blinded Trial To Evaluate The Safety, Tolerability And Immunogenicity Of A Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years
This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. The study will assess the safety and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.
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 on day 1, day 8, and day 30.
  • Biological: Placebo
    Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.
  • Experimental: High dose of C. difficile vaccine
    Intervention: Biological: Clostridium difficile vaccine
  • Experimental: Low dose of C. difficile vaccine
    Intervention: Biological: Clostridium difficile vaccine
  • Placebo Comparator: Placebo
    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.
 
Completed
185
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy male and female subjects aged 50 to 85 years

Exclusion Criteria:

Proven or suspected prior episode of Clostridium difficile associated diarrhea.

Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.

Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT02117570
B5091003
2013-004764-58 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

ICMJE     Data element required by the

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

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