Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children
NCT ID: NCT01954810
Last Updated: 2013-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
88 participants
INTERVENTIONAL
2013-10-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Japanese encephaltis chimerix vaccine
This is a single-arm study. Japanese encephalitis chimeric vaccine (JECV) will be administered to all subjects and check for antibody response 4 weeks after vaccination.
Japanese encephalitis chimeric vaccine (JECV)
Japanese encephalitis chimeric vaccine (JECV)will be administered to every children in the study for one dose and check for antibody response 4 weeks after vaccination
Interventions
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Japanese encephalitis chimeric vaccine (JECV)
Japanese encephalitis chimeric vaccine (JECV)will be administered to every children in the study for one dose and check for antibody response 4 weeks after vaccination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
3. Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
4. In good general health, based on medical history and physical examination
Exclusion Criteria
2. Planned participation in another clinical trial during the Day0-Day28 period
3. Receipt of live vaccine within 4 weeks preceding the trial vaccination
4. Planned receipt of any vaccine in the 4 weeks following the trial vaccination
5. Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
6. Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
7. Chronic illness or any underlying illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
72 Months
80 Months
ALL
Yes
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Pope Kosalaraksa
Associate Professor
Principal Investigators
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Pope Kosalaraksa, M.D.
Role: PRINCIPAL_INVESTIGATOR
Khon Kaen University
Locations
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Department of Pediatrics, Faculty of Medicine, Khon Kaen University
Muang, Changwat Khon Kaen, Thailand
Countries
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Central Contacts
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Facility Contacts
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Surapon Wiangnon, M.D.
Role: primary
Other Identifiers
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JEC24
Identifier Type: -
Identifier Source: org_study_id