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

This study has been terminated.
(Issues with CTM stability.)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00772954
First received: October 10, 2008
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Clostridium Difficile Infection
Clostridium Difficile Diarrhea
Biological: Vaccine diluent buffer
Biological: Clostridium difficile toxoid vaccine (50 μg)
Biological: Clostridium difficile toxoid vaccine (100 μg)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

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. [ Time Frame: Day 0 up to 70 days post first vaccination ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: March 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo vaccine group
Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.
Biological: Vaccine diluent buffer
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
Experimental: Clostridium Difficile Vaccine Group 1
Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
Biological: Clostridium difficile toxoid vaccine (50 μg)
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
Experimental: Clostridium Difficile Vaccine Group 2
Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
Biological: Clostridium difficile toxoid vaccine (100 μg)
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772954

Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Dennis N Morrison, D.O. Bio-Kinetic Clinical Applications, Inc.
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00772954     History of Changes
Other Study ID Numbers: H-030-010
Study First Received: October 10, 2008
Results First Received: March 13, 2012
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Clostridium difficile diarrhea
Clostridium difficile toxoid vaccine

Additional relevant MeSH terms:
Diarrhea
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 10, 2014