Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00237991
Status:
COMPLETED
Last Update Posted:
2008-10-16
First Post:
2005-10-12
Brief Title:
Safety of GlaxoSmithKline GSK Biologicals Hepatitis A Vaccine in Korean Population
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicentric Post-Marketing Surveillance to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals Hepatitis A Vaccine Administered in Korean Population
Status:
COMPLETED
Status Verified Date:
2008-10
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:
GlaxoSmithKline Korea has submitted a registration file for its hepatitis A vaccine The present study will collect clinical data in the local target population as per the requirement of Korean Food and Drugs administration FDA
Detailed Description:
All subjects will be administered one dose of the hepatitis A vaccine
Study Oversight
Has Oversight DMC:
None
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?:
None