Trial record 1 of 1 for:
H-030-008
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
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| ClinicalTrials.gov Identifier: NCT00127803 |
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Recruitment Status :
Completed
First Posted : August 9, 2005
Results First Posted : May 21, 2012
Last Update Posted : September 14, 2012
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention |
| Condition |
Clostridium Infections |
| Interventions |
Biological: Placebo (vaccine diluent) Biological: Clostridium difficile vaccine |
| Enrollment | 50 |
Participant Flow
| Recruitment Details | Participants were enrolled from 13 July 2005 to 27 July 2005 in 2 medical centers in the US. |
| Pre-assignment Details | A total of 50 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | Placebo Group | Low Dose Vaccine Group | Medium Dose Vaccine Group | High Dose Vaccine Group |
|---|---|---|---|---|
 Arm/Group Description |
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56. | Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56. | Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56. | Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56. |
| Period Title: Overall Study | ||||
| Started | 13 | 13 | 12 | 12 |
| Completed | 10 | 13 | 12 | 11 |
| Not Completed | 3 | 0 | 0 | 1 |
| Reason Not Completed | ||||
| Adverse Event | 2 | 0 | 0 | 0 |
| Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Lost to Follow-up | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Placebo Group | Low Dose Vaccine Group | Medium Dose Vaccine Group | High Dose Vaccine Group | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56. | Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56. | Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56. | Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 13 | 13 | 12 | 12 | 50 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 13 participants | 13 participants | 12 participants | 12 participants | 50 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
13 100.0%
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13 100.0%
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12 100.0%
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12 100.0%
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50 100.0%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 13 participants | 13 participants | 12 participants | 12 participants | 50 participants | |
| 33.6 (12.49) | 30.8 (10.26) | 30.4 (9.78) | 32.6 (9.07) | 31.9 (10.28) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 13 participants | 13 participants | 12 participants | 12 participants | 50 participants | |
| Female |
10 76.9%
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6 46.2%
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8 66.7%
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9 75.0%
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33 66.0%
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| Male |
3 23.1%
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7 53.8%
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4 33.3%
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3 25.0%
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17 34.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 13 participants | 13 participants | 12 participants | 12 participants | 50 participants |
| 13 | 13 | 12 | 12 | 50 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
| Name/Title: | Medical Director |
| Organization: | Sanofi Pasteur Inc. |
| EMail: | RegistryContactUs@sanofipasteur.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00127803 |
| Other Study ID Numbers: |
H-030-008 |
| First Submitted: | August 5, 2005 |
| First Posted: | August 9, 2005 |
| Results First Submitted: | March 13, 2012 |
| Results First Posted: | May 21, 2012 |
| Last Update Posted: | September 14, 2012 |