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

Japanese Encephalitis Clinical Trial

Official title:

Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001988
• Other study ID #: JEC05
• Secondary ID: U1111-1112-2127
• Status: Completed
• Phase: Phase 3
• First received: October 23, 2009
• Last updated: October 23, 2017
• Start date: August 7, 2009
• Est. completion date: October 16, 2013

Study information

• Verified date: October 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: October 16, 2013
• Est. primary completion date: October 16, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Other:
• Blood sample
Blood sample for immunogenicity assessment

Biological:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Philippines,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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
Primary	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.	Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination

External Links

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