Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine
      (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess
      the safety of the study vaccine compares to licenced vaccine. Two hundred and twenty children
      are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive
      2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data
      included immediate reaction at the injection site and systemic reaction within 30 min of
      administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34
      days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start
      of first dose to 28-34 days after second dose).
    

Detailed description: 
      Mouse brain-derived Japanese Encephalitis (JE) vaccine was developed in Vietnam since 1989
      with the support from WHO and BIKEN institute, Japan. It helped Viet Nam prevents Japanese
      Encephalitis outbreaks successfully during those years.

      However, mouse brain-derived JE vaccine production requires companies to compliance various
      requirements from WHO. Especially, WHO has a plan to replace the mouse brain-derived JE
      vaccines with Cell culture-derived JE vaccines.

      Vero cell-derived vaccine technology shows many advantages compares to Mouse brain-derived
      vaccine technology. VABIOTECH has been approved and sponsored by the Ministry of Science and
      Technology to produce Vero cell - derived JE vaccine. The vaccine demonstrated a good safety
      and immunogenicity profile in animal models. The vaccine has been proven safety in volunteer
      adults and in phase 2 which evaluated the safety and immunogenicity of 3 difference antigen
      concentrations.

      In this study, a selected dose of the studied vaccine (JECEVAX) derived from phase 2 will be
      compared the safety with a licensed vaccine (JEVAX-VABIOTECH Vietnam) in Vietnamese children,
      aged 9-24 months to assess the safety and immunogenicity. Two hundred and twenty children are
      enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2
      doses of investigate vaccines or control vaccine subcutaneously, at 28-34 days interval.
      Safety data included immediate reaction at the injection site and systemic reaction within 30
      min of administration, solicited and unsolicited adverse events occurs from the 1st dose to
      28-34 days after first dose (up to date of 2nd dose) and from the second dose to 28-34 days
      after 2nd dose (up to date of 3rd visit). SAE (from start of first dose to 28-34 days after
      second dose - date of 3rd visit).
    

Intervention name(s): JEVAX; JECEVAX
Intervention type(s): Biological; Biological
Intervention description(s): JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval; JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Japanese Encephalitis; JECEVAX; Vietnam