Status:
COMPLETED
Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children
Lead Sponsor:
Mahidol University
Conditions:
Encephalitis, Japanese B
Eligibility:
All Genders
1-3 years
Phase:
PHASE3
Brief Summary
Japanese encephalitis (JE) is the main cause of viral encephalitis in many countries of Asia including Thailand. Estimated annual mortality ranges from10,000-15,000 deaths, while the total number of c...
Eligibility Criteria
Inclusion
- Healthy Thai children aged 1- 3 years
- No previous history of JE vaccination
- Available for all visited schedule in the study period.
- Written inform consent signed by a parent or guardian
Exclusion
- Known serious underlying diseases such as nervous system, heart, kidney and liver diseases.
- Known hypersensitivity to JE vaccine composition such as human albumin, dextran 40, etc.
- Previous history of JE disease.
- Receive the blood component within the past 3 months,
- Known history of immunocompromised conditions such as HIV/AIDS, malignancy.
- Under treatment of immunosuppressive drugs such as systemic corticosteroid and anti-neoplastic drug.
- Febrile illness (temperature ≥37.5°C) or acute illness/infection on the day of vaccination
- Plan to leave the study area before the end of study period.
- Participating in other clinical trials.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01408537
Start Date
May 1 2010
End Date
December 1 2012
Last Update
November 18 2014
Active Locations (1)
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1
Department Tropical Pediatrics
Ratchathewi, Bangkok, Thailand, 10400