Trial record 1 of 1 for:
H-040-007
Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine
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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: NCT00981630 |
Recruitment Status :
Completed
First Posted : September 22, 2009
Results First Posted : December 5, 2012
Last Update Posted : December 5, 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: Live attenuated Japanese encephalitis virus Biological: ChimeriVax™ diluent (Placebo) |
Enrollment | 128 |
Participant Flow
Recruitment Details | Participants were enrolled from 01 December 2004 to 31 January 2005 at 2 clinical centers in Australia. |
Pre-assignment Details | A total of 128 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | ChimeriVax™-JE 3 log10 PFU | ChimeriVax™-JE 4 log10 PFU | ChimeriVax™-JE 5 log10 PFU | Placebo |
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All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0. | All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0. | All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0 | All participants received a single dose of Placebo (diluent) on Day 0. |
Period Title: Overall Study | ||||
Started | 32 | 32 | 32 | 32 |
Completed | 32 | 32 | 32 | 32 |
Not Completed | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | ChimeriVax™-JE 3 log10 PFU | ChimeriVax™-JE 4 log10 PFU | ChimeriVax™-JE 5 log10 PFU | Placebo | Total | |
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All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0. | All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0. | All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0 | All participants received a single dose of Placebo (diluent) on Day 0. | Total of all reporting groups | |
Overall Number of Baseline Participants | 32 | 32 | 32 | 32 | 128 | |
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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 | 32 participants | 32 participants | 32 participants | 32 participants | 128 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 |
32 100.0%
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32 100.0%
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32 100.0%
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32 100.0%
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128 100.0%
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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 | 32 participants | 32 participants | 32 participants | 32 participants | 128 participants | |
29.3 (7.62) | 26.7 (9.17) | 27.4 (8.31) | 29.4 (8.43) | 28.2 (8.38) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 32 participants | 32 participants | 32 participants | 32 participants | 128 participants | |
Female |
15 46.9%
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18 56.3%
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15 46.9%
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16 50.0%
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64 50.0%
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Male |
17 53.1%
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14 43.8%
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17 53.1%
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16 50.0%
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64 50.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Australia | Number Analyzed | 32 participants | 32 participants | 32 participants | 32 participants | 128 participants |
32 | 32 | 32 | 32 | 128 |
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: | NCT00981630 |
Other Study ID Numbers: |
H-040-007 |
First Submitted: | September 21, 2009 |
First Posted: | September 22, 2009 |
Results First Submitted: | November 6, 2012 |
Results First Posted: | December 5, 2012 |
Last Update Posted: | December 5, 2012 |