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

Primary Purpose

Encephalitis, Japanese Encephalitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Blood sample
JE-CV administered in Study JEC02
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Encephalitis focused on measuring Encephalitis, Japanese Encephalitis, Japanese Encephalitis Chimeric Virus Vaccine, Toddlers

Eligibility Criteria

2 Years - 3 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2009
Last Updated
October 23, 2017
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01001988
Brief Title
Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers
Official Title
Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 7, 2009 (Actual)
Primary Completion Date
October 16, 2013 (Actual)
Study Completion Date
October 16, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Japanese Encephalitis
Keywords
Encephalitis, Japanese Encephalitis, Japanese Encephalitis Chimeric Virus Vaccine, Toddlers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Blood sample for immunogenicity assessment
Intervention Type
Biological
Intervention Name(s)
JE-CV administered in Study JEC02
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV
Description
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
Title
Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

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

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