Trial record 1 of 1 for:
H-030-010
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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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Conditions |
Clostridium Difficile Infection Clostridium Difficile Diarrhea |
Interventions |
Biological: Vaccine diluent buffer Biological: Clostridium difficile toxoid vaccine (50 μg) Biological: Clostridium difficile toxoid vaccine (100 μg) |
Enrollment | 36 |
Participant Flow
Recruitment Details | Participants were enrolled on 28 March 2006 in 2 clinical centers in the US. |
Pre-assignment Details | A total of 36 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | Placebo Vaccine Group | Clostridium Difficile Toxoid Vaccine Group 1 | Clostridium Difficile Toxoid Vaccine Group 2 |
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Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28. | Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. | Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. |
Period Title: Overall Study | |||
Started | 12 | 12 | 12 |
Completed | 12 | 12 | 11 |
Not Completed | 0 | 0 | 1 |
Reason Not Completed | |||
Adverse Event | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Placebo Vaccine Group | Clostridium Difficile Toxoid Vaccine Group 1 | Clostridium Difficile Toxoid Vaccine Group 2 | Total | |
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Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28. | Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. | Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. | Total of all reporting groups | |
Overall Number of Baseline Participants | 12 | 12 | 12 | 36 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 12 participants | 12 participants | 36 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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Between 18 and 65 years |
12 100.0%
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12 100.0%
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12 100.0%
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36 100.0%
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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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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 12 participants | 12 participants | 12 participants | 36 participants | |
38.3 (12.98) | 36.9 (12.67) | 30.0 (8.57) | 35.1 (11.84) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 12 participants | 12 participants | 36 participants | |
Female |
7 58.3%
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11 91.7%
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5 41.7%
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23 63.9%
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Male |
5 41.7%
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1 8.3%
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7 58.3%
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13 36.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 12 participants | 12 participants | 12 participants | 36 participants |
12 | 12 | 12 | 36 |
Outcome Measures
Adverse Events
Limitations and Caveats
This study was terminated early in light of issues with CTM stability. All other study procedures and visits were performed per protocol.
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 |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00772954 |
Other Study ID Numbers: |
H-030-010 |
First Submitted: | October 10, 2008 |
First Posted: | October 15, 2008 |
Results First Submitted: | March 13, 2012 |
Results First Posted: | May 21, 2012 |
Last Update Posted: | May 21, 2012 |