Trial record 1 of 1 for:
JEC01
Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
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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: NCT00621764 |
Recruitment Status :
Completed
First Posted : February 22, 2008
Results First Posted : September 25, 2014
Last Update Posted : October 2, 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: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Japanese Encephalitis Hepatitis A |
Interventions |
Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28) Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28) |
Enrollment | 300 |
Participant Flow
Recruitment Details | The study participants were enrolled from 02 March 2008 to 06 January 2009 at 3 clinic centers in Thailand. |
Pre-assignment Details | A total of 300 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study. |
Arm/Group Title | JE-CV/Hepatitis A (Group 1) | Hepatitis A/JE-CV (Group 2) | JE-CV/Hepatitis A (Group 3) | Hepatitis A/JE-CV (Group 4) |
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Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart |
Period Title: Overall Study | ||||
Started | 50 | 50 | 101 | 99 |
Completed | 50 | 50 | 101 | 98 |
Not Completed | 0 | 0 | 0 | 1 |
Reason Not Completed | ||||
Protocol Violation | 0 | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | JE CV/Hepatitis A (Group 1) | Hepatitis A/JE CV (Group 2) | JE CV/Hepatitis A (Group 3) | Hepatitis A/JE CV (Group 4) | Total | |
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Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart | Total of all reporting groups | |
Overall Number of Baseline Participants | 50 | 50 | 101 | 99 | 300 | |
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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 | 50 participants | 50 participants | 101 participants | 99 participants | 300 participants | |
<=18 years |
50 100.0%
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50 100.0%
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101 100.0%
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99 100.0%
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300 100.0%
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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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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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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 | 50 participants | 50 participants | 101 participants | 99 participants | 300 participants | |
2.4 (0.5) | 2.5 (0.6) | 1.4 (0.2) | 1.3 (0.2) | 1.7 (0.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 50 participants | 101 participants | 99 participants | 300 participants | |
Female |
17 34.0%
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35 70.0%
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57 56.4%
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57 57.6%
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166 55.3%
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Male |
33 66.0%
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15 30.0%
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44 43.6%
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42 42.4%
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134 44.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Thailand | Number Analyzed | 50 participants | 50 participants | 101 participants | 99 participants | 300 participants |
50 | 50 | 101 | 99 | 300 |
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: | NCT00621764 |
Other Study ID Numbers: |
JEC01 |
First Submitted: | February 12, 2008 |
First Posted: | February 22, 2008 |
Results First Submitted: | September 9, 2014 |
Results First Posted: | September 25, 2014 |
Last Update Posted: | October 2, 2014 |