eutralizing Immunogenicity Antibody After 2 Intradermal Doses Pre-Exposure Prophylaxis of Purified Vero Cell Rabies Vaccine (PVRV) to 12-24 month-old Children, concomitantly with Chimeric Live-Attenuated JE Vaccine (IMOJEV)
Phase 4
Active, not recruiting
- Conditions
- Rabies vaccination,Japanese encephalitis,To describe immune response and proportion of seroprotective level of JE at baseline prebooster vaccinationRabies,Japanese encephalitis vaccination
- Registration Number
- TCTR20180531004
- Lead Sponsor
- Queen Saovabha Memorial Institute, The Thai Red Cross Society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 49
Inclusion Criteria
1) Children aged 12-24 months 2) In a good general health after physical exam at the time of inclusion 3) Informed consent form has been signed and dated by the parent(s)/legal guardian(s) 4) Be able to complete the vaccine course and every blood sample collection
Exclusion Criteria
1) History of receiving rabies vaccination or Rabies Nab titers ≥ 0.5 IU/ml 2) History of receiving JE vaccination 3) Contraindications to Live attenuated vaccine i.e. immunodeficiency, cancer with treatment of immunosuppressive agents 4) Parents reject to participate in study 5) History of receiving any vaccine in the 8 weeks preceding the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the immunogenicity of new two-visit intradermal regimen (day 0 and 28) compared with the c Day 0, 42 and 365 Rabies Neutralizing Antibody
- Secondary Outcome Measures
Name Time Method To assess the immunogenicity of chimeric JE vaccine after receiving primary and booster JE vaccinati day 0, day 42, day 365 and 379 Geometric mean titer for JE neutralizing antibody