Trial record 1 of 1 for:
H-040-006
Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)
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ClinicalTrials.gov Identifier: NCT00982137 |
Recruitment Status :
Completed
First Posted : September 22, 2009
Results First Posted : September 20, 2012
Last Update Posted : September 20, 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 |
Conditions |
Japanese Encephalitis Yellow Fever |
Interventions |
Biological: Live attenuated Japanese encephalitis virus; Yellow fever virus Biological: Yellow fever virus; Live attenuated Japanese encephalitis virus |
Enrollment | 108 |
Participant Flow
Recruitment Details | Participants were screened and enrolled from 27 July 2004 to 27 September 2004 at 1 clinical center in Australia. |
Pre-assignment Details | A total of 108 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | ChimeriVax™-JE Then STAMARIL® | STAMARIL® Then ChimeriVax™-JE | Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® |
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All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30. | All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30. | All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. | All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. |
Period Title: Overall Study | ||||
Started | 36 | 36 | 18 | 18 |
Completed | 36 | 35 | 18 | 17 |
Not Completed | 0 | 1 | 0 | 1 |
Reason Not Completed | ||||
Lost to Follow-up | 0 | 0 | 0 | 1 |
Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | ChimeriVax™-JE Then STAMARIL® | STAMARIL® Then ChimeriVax™-JE | Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | Total | |
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All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30. | All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30. | All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. | All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. | Total of all reporting groups | |
Overall Number of Baseline Participants | 36 | 36 | 18 | 18 | 108 | |
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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 | 36 participants | 36 participants | 18 participants | 18 participants | 108 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 |
36 100.0%
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36 100.0%
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18 100.0%
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18 100.0%
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108 100.0%
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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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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 36 participants | 36 participants | 18 participants | 18 participants | 108 participants | |
27.2 (9.71) | 23.4 (6.95) | 27.5 (10.19) | 25.8 (8.26) | 25.8 (8.77) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 36 participants | 36 participants | 18 participants | 18 participants | 108 participants | |
Female |
16 44.4%
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13 36.1%
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10 55.6%
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7 38.9%
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46 42.6%
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Male |
20 55.6%
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23 63.9%
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8 44.4%
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11 61.1%
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62 57.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Australia | Number Analyzed | 36 participants | 36 participants | 18 participants | 18 participants | 108 participants |
36 | 36 | 18 | 18 | 108 |
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: | NCT00982137 |
Other Study ID Numbers: |
H-040-006 |
First Submitted: | September 21, 2009 |
First Posted: | September 22, 2009 |
Results First Submitted: | July 11, 2012 |
Results First Posted: | September 20, 2012 |
Last Update Posted: | September 20, 2012 |