Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children

NCT ID: NCT01954810

Last Updated: 2013-10-08

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-05-31

Brief Summary

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This study has aim to describe the immune response to the second dose of Japanese encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV 5 years ago.

Detailed Description

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This is a prospective study to demonstrate the boosting antibody response in children previously vaccinated with one dose of JECV 5 years ago.

Conditions

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Japanese Encephalitis

Keywords

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JECV IMOJEV Booster response Children antibody response Duration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type NO_INTERVENTION

Japanese encephalitis chimeric vaccine (JECV)

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Other Intervention Names

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IMOJEV

Eligibility Criteria

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Inclusion Criteria

1. Subject who was vaccinated with 1 dose JE-CV in JEC02 and participated in 5 year follow-up in JEC05 trial and finished year 5 of follow-up.
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

1. Participation in another clinical trial investigating a vaccine which need to have vaccination or blood draw within the 4 weeks preceding the trial vaccination except JEC05
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
Minimum Eligible Age

72 Months

Maximum Eligible Age

80 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Pope Kosalaraksa

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Thailand

Central Contacts

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Pope Kosalaraksa, M.D.

Role: CONTACT

Phone: +66-89-7112236

Email: [email protected]

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