Study of long term immunogenicity of a live attenuated SA14-14-2 JE Vaccine (CD.JEVAX) as a booster dose after priming with chimeric JE Vaccine (IMOJEV) in Thai children.
- Conditions
- ong term immunogenicity of CD.JEVAX as a booster does in Thai children previously vaccinated against JE with IMOJEV at least 12 months prior to the project by blood test once a year for 5 years.CD.JEVAX, IMOJEV
- Registration Number
- TCTR20221102003
- Lead Sponsor
- Queen Sirikit National Institute of Child Health
- Brief Summary
A Booster dose of CDJEVAX vaccination elicits very strong immune responses in children previously vaccinated with IMOJEV, indicated interchangeability of these 2 vaccines. Statistical models predicted individual neutralizing antibody titres and seroprotection up to 10 years postvaccination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1.Children (any gender) aged 1 to < 5 years on day of enrollment.
2.History of received 1 dose of IMOJEV as primary JE vaccination at least 1 year to 2 years prior to enrollment for booster dose.
3.In good general health at enrollment.
4.Informed consent by parent(s) or legal guardian(s)
5.Able to follow up for 28-35 days after enrollment.
6.Has not been received any vaccine within 30 days before enrollment.
1.Acute febrile illness on day of vaccination.
2.Had been received any JE vaccine before (except IMOJEV for 1 dose).
3.Receipt of blood or blood products in the past 3 months or plan to receive blood or 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 received any vaccine within 30 days prior study vaccine.
7.Planned to receive 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 Geometric mean titers Day 0, Day 30, Year 1-5 50% Plaque Reduction Neutralization Test (PRNT50).
- Secondary Outcome Measures
Name Time Method Seroprotection rate Day 0, Day 30, Year 1-5 Bayesian method