Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-26 @ 7:26 PM
Study NCT ID:
NCT02526550
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2015-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Sponsor:
Siriraj Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: