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Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers

NCT ID: NCT01001988

Last Updated: 2017-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-07

Study Completion Date

2013-10-16

Brief Summary

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This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) . No vaccination was administered during the present long-term follow-up study.

Primary Objective:

* To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Detailed Description

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Persistence of immune response will be determined in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644). No vaccination will be given in this study.

Conditions

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Encephalitis Japanese Encephalitis

Keywords

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Encephalitis Japanese Encephalitis Japanese Encephalitis Chimeric Virus Vaccine Toddlers

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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Study group

Participants received a single dose of JE-CV administered in Study JEC02. In Study JEC05 there were yearly visits with blood samples taken for immunogenicity assessment.

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

Blood sample for immunogenicity assessment

JE-CV administered in Study JEC02

Intervention Type BIOLOGICAL

Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05

Interventions

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Blood sample

Blood sample for immunogenicity assessment

Intervention Type OTHER

JE-CV administered in Study JEC02

Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
* Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial.
* Participant and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria

* Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up to inclusion in JEC05 trial.
* Planned participation in another clinical trial up to the first year of the follow-up in the present trial.
Minimum Eligible Age

2 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

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City of Muntinlupa, , Philippines

Site Status

Bangkok, , Thailand

Site Status

Bangkok, , Thailand

Site Status

Khon Kaen, , Thailand

Site Status

Countries

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Philippines Thailand

Related Links

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http://www.sanofipasteur.com

Related Info

Other Identifiers

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U1111-1112-2127

Identifier Type: OTHER

Identifier Source: secondary_id

JEC05

Identifier Type: -

Identifier Source: org_study_id