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

Phase 3

Completed

• Conditions: Japanese Encephalitis; Encephalitis
• Interventions: Other: Blood sample; Biological: JE-CV administered in Study JEC02

• Registration Number: NCT01001988
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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

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 Timeline

• Study Start: 2009-08-07
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-27
• Primary Completion: 2013-10-16
• Study Completion: 2013-10-16
• Results First Submitted: 2017-09-18
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-23
• Last Update Submitted: 2017-10-23
• Results First Posted: 2017-11-29
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Blood sample	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.
Study group	JE-CV administered in Study JEC02	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV	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	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).
Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV	Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination	Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.