Trial record 1 of 1 for:
H-244-004
Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults (WinVax004)
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| ClinicalTrials.gov Identifier: NCT00746798 |
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Recruitment Status :
Completed
First Posted : September 4, 2008
Results First Posted : November 2, 2011
Last Update Posted : April 3, 2015
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
- Study Details
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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 |
West Nile Fever |
| Interventions |
Biological: ChimeriVax-WN02 vaccine Biological: Placebo |
| Enrollment | 479 |
Participant Flow
| Recruitment Details | Participants were enrolled from 03 October 2008 to 08 December 2008 in 15 clinical centers in the US. |
| Pre-assignment Details | A total of 498 of the 479 randomized participants who met the inclusion and exclusion criteria were vaccinated. 1 subject was withdrawn from the study before receiving any study vaccine and was excluded from analysis and this report. |
| Arm/Group Title | ChimeriVax WN02 Vaccine Low Dose | ChimeriVax WN02 Vaccine Medium Dose | ChimeriVax WN02 Vaccine High Dose | Placebo |
|---|---|---|---|---|
 Arm/Group Description |
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously | Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously | Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously | Participants who received placebo (saline) given one time subcutaneously |
| Period Title: Overall Study | ||||
| Started | 122 | 124 | 113 | 120 |
| Completed | 121 | 122 | 110 | 120 |
| Not Completed | 1 | 2 | 3 | 0 |
| Reason Not Completed | ||||
| Protocol Violation | 0 | 1 | 0 | 0 |
| Withdrawal by Subject | 0 | 1 | 1 | 0 |
| Death | 0 | 0 | 2 | 0 |
| Participant unable to return for visit | 1 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | ChimeriVax WN02 Vaccine Low Dose | ChimeriVax WN02 Vaccine Medium Dose | ChimeriVax WN02 Vaccine High Dose | Placebo | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously | Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously | Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously | Participants who received placebo (saline) given one time subcutaneously | Total of all reporting groups | |
| Overall Number of Baseline Participants | 122 | 124 | 113 | 120 | 479 | |
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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 | 122 participants | 124 participants | 113 participants | 120 participants | 479 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 |
72 59.0%
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75 60.5%
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62 54.9%
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76 63.3%
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285 59.5%
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| >=65 years |
50 41.0%
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49 39.5%
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51 45.1%
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44 36.7%
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194 40.5%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 122 participants | 124 participants | 113 participants | 120 participants | 479 participants | |
| 63.1 (9.39) | 62.9 (8.10) | 63.4 (9.01) | 62.2 (8.28) | 62.9 (8.69) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 122 participants | 124 participants | 113 participants | 120 participants | 479 participants | |
| Female |
76 62.3%
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65 52.4%
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63 55.8%
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64 53.3%
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268 55.9%
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| Male |
46 37.7%
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59 47.6%
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50 44.2%
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56 46.7%
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211 44.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 122 participants | 124 participants | 113 participants | 120 participants | 479 participants |
| 122 | 124 | 113 | 120 | 479 | ||
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 |
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT00746798 |
| Other Study ID Numbers: |
H-244-004 |
| First Submitted: | September 2, 2008 |
| First Posted: | September 4, 2008 |
| Results First Submitted: | September 27, 2011 |
| Results First Posted: | November 2, 2011 |
| Last Update Posted: | April 3, 2015 |