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

NCT01001988

CompletedPhase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Encephalitis, Japanese Encephalitis

Interventions: Blood sample, JE-CV administered in Study JEC02

Countries: Philippines, Thailand

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

Eligibility overview

Sex: ALL

Age: 2 Years to 3 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (4)

City of Muntinlupa, Philippines
Bangkok, Thailand
Bangkok, Thailand
Khon Kaen, Thailand