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

Phase 3CompletedNCT01001988

Sanofi Pasteur, a Sanofi Company596 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

596

Conditions

Encephalitis Japanese Encephalitis

Interventions

Blood sampleOTHER

Blood sample for immunogenicity assessment

JE-CV administered in Study JEC02BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Unnamed facility

City of Muntinlupa, Philippines

Unnamed facility

Bangkok, Thailand

Unnamed facility

Bangkok, Thailand

Unnamed facility

Khon Kaen, Thailand

Outcomes

Primary Outcomes

Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV

Seroprotection was defined as the proportion of participants with Japanese encephalitis virus neutralizing antibody titers ≥10 1/dil as measured by a JE 50% plaque reduction neutralization test (PRNT50).

Time frame: Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination

Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV

Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.

Time frame: Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination

Data from ClinicalTrials.gov

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