Safety and Immunogenicity of JECEVAX in Young Children
Japanese Encephalitis
About this trial
This is an interventional prevention trial for Japanese Encephalitis focused on measuring Japanese Encephalitis, JECEVAX, Vietnam
Eligibility Criteria
Inclusion Criteria:
- Healthy children of both sexes, 9-24 months of age;
- Have not been vaccinated with JE vaccine;
- Not have any chronic disease;
- Parents/legal guardians agree to participate their children in this study and sign the informed consent.
Exclusion Criteria:
- Currently has chronic diseases (cardiovascular, liver and spleen related etc);
- Currently has acute diseases;
- Use (orally or injection) with corticosteroid containing drug (>1 mg / kg dose);
- Use of immunocompromised treatment within 4 weeks of enrollment;
- Being immunocompromised and autoimmune diseases (HIV, lupus);
- The family history of immunocompromised;
- History of febrile seizure;
- Allergic to any vaccine component;
- Fever (>38 Celsius degree) within 3 days before vaccination or at enrollment;
- Malnourished (3rd grade or above);
- Blood disorder;
- Use of vaccines which have not been licenced 7 days before enrolment in this study
Sites / Locations
- District Health Center
- Phu Tho Preventive Medicine Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
JECEVAX-1
JECEVAX-0.8
JECEVAX-0.5
JEVAX
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1.0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12days
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days