Long 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
Conditions
Interventions
Sponsors
Queen Sirikit National Institute of Child Health
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titers Day 0, Day 30, Year 1-5 50% Plaque Reduction Neutralization Test (PRNT50). | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroprotection rate Day 0, Day 30, Year 1-5 Bayesian method | — |
Countries
Thailand
Contacts
Public ContactTawee Chotpitayasunondh
Queen Sirikit National Institute of Child Health
Outcome results
None listed