Trial record 1 of 1 for:
H-040-009
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00314145 |
Recruitment Status :
Completed
First Posted : April 13, 2006
Results First Posted : December 5, 2012
Last Update Posted : December 6, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Condition |
Japanese Encephalitis |
Interventions |
Biological: ChimeriVax™-JE Biological: JE-VAX® |
Enrollment | 820 |
Participant Flow
Recruitment Details | Participants were enrolled and treated from 07 November 2005 to 15 November 2006 at 5 clinical centers in Australia and 5 clinical centers in the US. |
Pre-assignment Details | A total of 820 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | JE-VAX® | ChimeriVax™-JE |
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All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30. | All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms. |
Period Title: Overall Study | ||
Started | 410 | 410 |
Completed | 389 | 381 |
Not Completed | 21 | 29 |
Reason Not Completed | ||
Withdrawal by Subject | 8 | 10 |
Lost to Follow-up | 5 | 12 |
Physician Decision | 3 | 4 |
Adverse Event | 0 | 3 |
Protocol Violation | 3 | 0 |
Sponsor Decision | 2 | 0 |
Baseline Characteristics
Arm/Group Title | JE-VAX® | ChimeriVax™-JE | Total | |
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All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30. | All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms. | Total of all reporting groups | |
Overall Number of Baseline Participants | 410 | 410 | 820 | |
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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 | 410 participants | 410 participants | 820 participants | |
<=18 years |
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 |
410 100.0%
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410 100.0%
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820 100.0%
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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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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 410 participants | 410 participants | 820 participants | |
37.0 (14.81) | 37.7 (15.11) | 37.4 (14.96) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 410 participants | 410 participants | 820 participants | |
Female |
205 50.0%
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217 52.9%
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422 51.5%
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Male |
205 50.0%
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193 47.1%
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398 48.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 410 participants | 410 participants | 820 participants |
Australia | 203 | 120 | 323 | |
United States | 207 | 290 | 497 |
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: | NCT00314145 |
Other Study ID Numbers: |
H-040-009 |
First Submitted: | April 11, 2006 |
First Posted: | April 13, 2006 |
Results First Submitted: | November 6, 2012 |
Results First Posted: | December 5, 2012 |
Last Update Posted: | December 6, 2012 |