Trial record 1 of 1 for:
H-040-008
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-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: NCT00319592 |
Recruitment Status :
Completed
First Posted : April 27, 2006
Results First Posted : August 16, 2012
Last Update Posted : August 20, 2012
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Sponsor:
Sanofi
Collaborator:
PRA Health Sciences
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 vaccine Biological: JE-VAX® vaccine |
Enrollment | 60 |
Participant Flow
Recruitment Details | Participants were enrolled from 18 May 2005 to 07 September 2005 at 1clinical center in the United States. |
Pre-assignment Details | A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | ChimeriVax™-JE After Placebo | JE-VAX® |
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Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28. | Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. |
Period Title: Overall Study | ||
Started | 30 | 30 |
Completed | 29 | 29 |
Not Completed | 1 | 1 |
Reason Not Completed | ||
Protocol Violation | 1 | 0 |
Physician Decision | 0 | 1 |
Baseline Characteristics
Arm/Group Title | ChimeriVax™-JE After Placebo | JE-VAX® | Total | |
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Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28. | Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. | Total of all reporting groups | |
Overall Number of Baseline Participants | 30 | 30 | 60 | |
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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 | 30 participants | 30 participants | 60 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 |
30 100.0%
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30 100.0%
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60 100.0%
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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 | 30 participants | 30 participants | 60 participants | |
32.7 (8.82) | 29.2 (9.14) | 31 (8.98) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 30 participants | 30 participants | 60 participants | |
Female |
16 53.3%
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16 53.3%
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32 53.3%
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Male |
14 46.7%
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14 46.7%
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28 46.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 30 participants | 30 participants | 60 participants |
30 | 30 | 60 |
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 |
ClinicalTrials.gov Identifier: | NCT00319592 |
Other Study ID Numbers: |
H-040-008 |
First Submitted: | April 28, 2006 |
First Posted: | April 27, 2006 |
Results First Submitted: | July 11, 2012 |
Results First Posted: | August 16, 2012 |
Last Update Posted: | August 20, 2012 |