Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT01003418
Status:
TERMINATED
Last Update Posted:
2019-02-15
First Post:
2009-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 8 to 12 Weeks
Status:
TERMINATED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated prematurely for logistic reasons, not related to safety or efficacy of the vaccine.
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 assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.
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?: