Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
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ClinicalTrials.gov Identifier: NCT00772954 |
Recruitment Status :
Terminated
(Issues with CTM stability.)
First Posted : October 15, 2008
Results First Posted : May 21, 2012
Last Update Posted : May 21, 2012
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Condition or disease | Intervention/treatment | Phase |
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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 (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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) |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo vaccine group
Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.
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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.
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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.
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Biological: Clostridium difficile toxoid vaccine (100 μg)
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively. |
- 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 ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772954
Principal Investigator: | Dennis N Morrison, D.O. | Bio-Kinetic Clinical Applications, Inc. |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00772954 |
Other Study ID Numbers: |
H-030-010 |
First Posted: | October 15, 2008 Key Record Dates |
Results First Posted: | May 21, 2012 |
Last Update Posted: | May 21, 2012 |
Last Verified: | April 2012 |
Clostridium difficile diarrhea Clostridium difficile toxoid vaccine |
Clostridium Infections Diarrhea Signs and Symptoms, Digestive Gram-Positive Bacterial Infections Bacterial Infections |
Bacterial Infections and Mycoses Infections Vaccines Immunologic Factors Physiological Effects of Drugs |