Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children

This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.

The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.

Inclusion Criteria:

• Children aged 1 to <5 years on the day of inclusion
• History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
• In good general health at the time of inclusion
• Provision of informed consent by the parent(s) or legal guardian(s)

Exclusion Criteria:

• Receipt of blood or blood products in the past 3 months
• Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
• Previous receipt of 2 doses of any vaccine against JE virus
• Known hypersensitivity to any of the vaccine components
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination