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

NCT02561195

Last updated date
Study Location
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clostridium Difficile Associated Disease
Intervention  ICMJE
  • Biological: Clostridium difficile Vaccine
    0.5 mL intramuscular injection.
  • Biological: Placebo
    0.5 mL intramuscular injection
Study Arms  ICMJE
  • 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
Publications * 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.

*   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
 (submitted: May 26, 2020)
944
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2015)
854
Actual Study Completion Date  ICMJE February 13, 2020
Actual Primary Completion Date March 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02561195
Other Study ID Numbers  ICMJE B5091009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP