Trial record 1 of 1 for:
H-030-009
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
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| ClinicalTrials.gov Identifier: NCT00214461 |
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Recruitment Status :
Completed
First Posted : September 22, 2005
Results First Posted : April 9, 2012
Last Update Posted : April 11, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Condition |
Clostridium Infections |
| Interventions |
Biological: Vaccine diluent buffer (Placebo) Biological: C. difficile toxoid vaccine (2 µg) Biological: C. difficile toxoid vaccine (10 µg) Biological: C. difficile toxoid vaccine (50 µg) |
| Enrollment | 48 |
Participant Flow
| Recruitment Details | Participants were enrolled and treated from 01 November 2005 to 11 October 2006 in 3 medical centers in the US. |
| Pre-assignment Details | A total of 48 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | Placebo Vaccine Group | Low-dose C. Difficile Vaccine Group | Medium-dose C. Difficile Vaccine Group | High-dose C. Difficile Vaccine Group |
|---|---|---|---|---|
 Arm/Group Description |
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively. | Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively. | Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively. | Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively. |
| Period Title: Overall Study | ||||
| Started | 12 | 12 | 12 | 12 |
| Completed | 12 | 12 | 10 | 11 |
| Not Completed | 0 | 0 | 2 | 1 |
| Reason Not Completed | ||||
| Adverse Event | 0 | 0 | 1 | 1 |
| Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo Vaccine Group | Low-dose C. Difficile Vaccine Group | Medium-dose C. Difficile Vaccine Group | High-dose C. Difficile Vaccine Group | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively. | Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively. | Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively. | Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 12 | 12 | 12 | 12 | 48 | |
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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 | 12 participants | 12 participants | 12 participants | 12 participants | 48 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 |
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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| >=65 years |
12 100.0%
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12 100.0%
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12 100.0%
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12 100.0%
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48 100.0%
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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 | 12 participants | 48 participants | |
| 69.0 (3.59) | 72.2 (5.32) | 75.5 (6.47) | 68.9 (4.32) | 71.4 (5.60) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 12 participants | 12 participants | 12 participants | 12 participants | 48 participants | |
| Female |
6 50.0%
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8 66.7%
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5 41.7%
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7 58.3%
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26 54.2%
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| Male |
6 50.0%
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4 33.3%
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7 58.3%
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5 41.7%
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22 45.8%
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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 | 12 participants | 48 participants |
| 12 | 12 | 12 | 12 | 48 | ||
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: | NCT00214461 |
| Other Study ID Numbers: |
H-030-009 |
| First Submitted: | September 16, 2005 |
| First Posted: | September 22, 2005 |
| Results First Submitted: | March 13, 2012 |
| Results First Posted: | April 9, 2012 |
| Last Update Posted: | April 11, 2012 |