Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01114620
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2010-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine Arepanrix™ (GSK2340274A) in Adults 65 Years of Age or Older
Status:
COMPLETED
Status Verified Date:
2019-10
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:
The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: