search
Back to results

Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

Primary Purpose

Clostridium Difficile Infection, Clostridium Difficile Diarrhea

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Vaccine diluent buffer
Clostridium difficile toxoid vaccine (50 μg)
Clostridium difficile toxoid vaccine (100 μg)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Clostridium difficile diarrhea, Clostridium difficile toxoid vaccine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult males or females, 18 - 55 years in good general health

Exclusion Criteria:

  • Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening
  • Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication
  • Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Placebo vaccine group

    Clostridium Difficile Vaccine Group 1

    Clostridium Difficile Vaccine Group 2

    Arm Description

    Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.

    Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.

    Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.

    Outcomes

    Primary Outcome Measures

    Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2008
    Last Updated
    April 19, 2012
    Sponsor
    Sanofi
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00772954
    Brief Title
    Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
    Official Title
    A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of Two Doses of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Adult Volunteers (18 - 55 Years)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Terminated
    Why Stopped
    Issues with CTM stability.
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sanofi

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.
    Detailed Description
    This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of C. difficile vaccine. The study was conducted in healthy male and female adults, 18 to 55 years old. Subjects was randomly assigned on Day 0 to receive one of two doses of C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clostridium Difficile Infection, Clostridium Difficile Diarrhea
    Keywords
    Clostridium difficile diarrhea, Clostridium difficile toxoid vaccine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo vaccine group
    Arm Type
    Placebo Comparator
    Arm Description
    Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.
    Arm Title
    Clostridium Difficile Vaccine Group 1
    Arm Type
    Experimental
    Arm Description
    Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
    Arm Title
    Clostridium Difficile Vaccine Group 2
    Arm Type
    Experimental
    Arm Description
    Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
    Intervention Type
    Biological
    Intervention Name(s)
    Vaccine diluent buffer
    Intervention Description
    0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
    Intervention Type
    Biological
    Intervention Name(s)
    Clostridium difficile toxoid vaccine (50 μg)
    Intervention Description
    0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
    Intervention Type
    Biological
    Intervention Name(s)
    Clostridium difficile toxoid vaccine (100 μg)
    Intervention Description
    0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
    Primary Outcome Measure Information:
    Title
    Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.
    Time Frame
    Day 0 up to 70 days post first vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult males or females, 18 - 55 years in good general health Exclusion Criteria: Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dennis N Morrison, D.O.
    Organizational Affiliation
    Bio-Kinetic Clinical Applications, Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

    We'll reach out to this number within 24 hrs