Encephalitis, Japanese B Clinical Trial
Official title:
Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children
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 clinical cases is about 50,000. Of these cases, about 50% result in
permanent neuropsychiatric sequelae. The disease occurs mostly among children aged <10
years. There is no specific antiviral treatment for JE. Vaccination is the single most
important control measure. This study aims to evaluate the immunogenicity and safety of
inactivated Vero cell derived JE vaccine (Beijing P-3 strain) produced by Liaoning Cheng Da
Biotechnology Co., Ltd, China "JEVAC" in Thai children.
152 healthy Thai children aged between 1-3 years will be vaccinated with "JEVAC" in a dose
of 0.5 mL. subcutaneously on Day 0, 1-4 weeks later and a booster vaccination at one year
(totally 3 doses). Two mL. of blood will be drawn on Day 0, 4 weeks after second dose, at
one year on booster vaccination day and 4 weeks after the booster (totally 8 mL. of 13
months study period) for determination of JE neutralizing antibodies (PRNT50) using Beijing
P3 strain. Adverse events will be observed for 28 days after each vaccination. Serious
adverse events will be observed throughout the study period.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 3 | |
| Completed |
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Phase 3 |