Trial record 1 of 2 for:
JEC12
Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers
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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: NCT01396512 |
Recruitment Status :
Completed
First Posted : July 18, 2011
Results First Posted : April 25, 2014
Last Update Posted : April 25, 2014
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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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 Japanese Encephalitis Virus Disease |
Interventions |
Biological: Live attenuated Japanese encephalitis chimeric virus vaccine Biological: Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine) |
Enrollment | 274 |
Participant Flow
Recruitment Details | The study participants were enrolled from 12 July 2011 to 28 September 2012 at 10 clinic centers in South Korea. |
Pre-assignment Details | A total of 274 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study. |
Arm/Group Title | IMOJEV™ Vaccine Group | CD.JEVAX™ Vaccine Group |
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Participants age 12 to 24 months received one dose of IMOJEV™ | Participants age 12 to 24 months received one dose of CD.JEVAX™ |
Period Title: Overall Study | ||
Started | 137 | 137 |
Completed | 137 | 136 |
Not Completed | 0 | 1 |
Reason Not Completed | ||
Withdrawal by Subject | 0 | 1 |
Baseline Characteristics
Arm/Group Title | IMOJEV™ Vaccine Group | CD.JEVAX™ Vaccine Group | Total | |
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Participants age 12 to 24 months received one dose of IMOJEV™ | Participants age 12 to 24 months received one dose of CD.JEVAX™ | Total of all reporting groups | |
Overall Number of Baseline Participants | 137 | 137 | 274 | |
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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 | 137 participants | 137 participants | 274 participants | |
<=18 years |
137 100.0%
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137 100.0%
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274 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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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: Months |
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Number Analyzed | 137 participants | 137 participants | 274 participants | |
14.0 (2.0) | 14.3 (2.2) | 14.2 (2.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 137 participants | 137 participants | 274 participants | |
Female |
58 42.3%
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57 41.6%
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115 42.0%
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Male |
79 57.7%
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80 58.4%
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159 58.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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South Korea | Number Analyzed | 137 participants | 137 participants | 274 participants |
137 | 137 | 274 |
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 ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT01396512 |
Other Study ID Numbers: |
JEC12 U1111-1117-7378 ( Other Identifier: WHO ) |
First Submitted: | July 14, 2011 |
First Posted: | July 18, 2011 |
Results First Submitted: | March 24, 2014 |
Results First Posted: | April 25, 2014 |
Last Update Posted: | April 25, 2014 |