Safety and immunogenicity of a booster dose of inactivated Vero-cell derived Japanese Encephalitis vaccine (JEVAC) in children whom primed with live attenuated JE vaccine.
- Conditions
- Immungenicity of booster dose of inactivated or live attenuated JE vaccine in children 20-30 month whom had primed with any live attenuated JE vaccine to ensure prevention of Japanese Encephalitis.Japanese encephalitis, JE vaccine, inactivated JE vaccine, live attenuated JE vaccine, , immunogenicity, safety
- Registration Number
- TCTR20220412006
- Lead Sponsor
- Biovalys Co., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 140
1.Children (any gender) aged 20-30 months on day of enrollment, 2.History of recieved 1 dose of IMOJEV or CD JEVAX as primary JE vaccination at 12-18 months prior to enrollment for booster dose, 3.In good general health at enrollment, 4.Informed consent by parent(s) or legal gardian(s), 5.Able to follow up for 1 year (+1 month) after enrollment
1.Acute febrile illness on day of vaccination (Body temperature is equal or more than 38 degree Celsius), 2.Had been recieved any JE vaccine before (except IMOJEV or CD JEVAX for 1 dose only), 3.Reciept of blood products in the past 3 months or plan to recieve blood product within 1 month after enrollment, 4.Known hypersensitivity of vaccine component, 5.Any confirmed or suspected immunosuppress or immunodeficient condition, by medical history or physical examination, 6.Had been recieved any vaccine within 30 days prior study vaccine, 7.Planned to recieve any vaccine within 30 days after enrollment, 8.Not participating in any clinical trial for drug or vaccine 30 days before and after enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity at baseline and at 42 and 365 days after booster in both arms The geometric mean titer (GMT) of JE neutralizing antibody,Rate of seroprotective level of JE neutralizing antiboy 30 minutes after booster and 7 days and 42 days after vaccination Occurrence of MedDRA, time to onset, intensity, duration related to vaccination of any unsolicited systemic adverse events
- Secondary Outcome Measures
Name Time Method Safety 30 minutes after booster and 7 days and 42 days after vaccination Occurrence of MedDRA, time to onset, intensity, duration related to vaccination of any unsolicited systemic adverse events