NCT02526550

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Siriraj Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated chimeric Japanese Encephalitis vaccine	0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
BIOLOGICAL	Inactivated Hepatitis A vaccine	0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2015-08-18
• Last updated: 2016-12-07
• Results posted: 2016-12-07