Status:
COMPLETED
Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Encephalitis
Japanese Encephalitis
Eligibility:
All Genders
2-3 years
Phase:
PHASE3
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 ...
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 7 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2013
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT01001988
Start Date
August 7 2009
End Date
October 16 2013
Last Update
November 29 2017
Active Locations (4)
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1
City of Muntinlupa, Philippines, 1781
2
Bangkok, Thailand, 10330
3
Bangkok, Thailand, 10400
4
Khon Kaen, Thailand, 40002