Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT00695669
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2008-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Trial to Evaluate the Immunogenicity of Accelerated Primary Vaccination With Monovalent A/Indonesia/5/05 (H5N1) Vaccine Antigen in Association With AS03 Adjuvant in Adults Aged 18-64
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:
The purpose of the study is to characterize the immunogenicity \& safety of 2 doses of GSK's avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64 years
Detailed Description:
A Phase 2, open-label, randomized, parallel group, multi-centered study designed to evaluate the immunogenicity and safety of a 2-dose series of avian influenza vaccine plus AS03 adjuvant according to different regimens, in adults aged 18-64 years. All subjects will receive active study vaccine; no subjects are to receive placebo. A total of 312 subjects will be enrolled in this study at approximately 3 study centers in Canada. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 21, 42, and 182. Additional formal study center visits will be scheduled at additional timepoints for subjects in particular dose groups. In addition, a telephone call will be conducted for all subjects on Day 51
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?: