Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309647
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2006-03-31
Brief Title:
Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent H5N1 Influenza Vaccines Whole Virus Formulation in Adults 18 and 60 Years of Age
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Partially-blind Multi-centric Study in Adults Aged Between 18-60 Years Designed to Evaluate the Reactogenicity and Immunogenicity of 1 and 2 Doses of Pandemic Monovalent H5N1 Influenza Vaccines Whole Virus Formulation Administered at Different Doses and Adjuvanted or Not
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Today the leading contender for the next pandemic of influenza is H5N1 a strain of avian virus Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines Candidate pandemic-like vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination scheduleThis study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus The vaccines contain different antigen doses For each dose adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain
Detailed Description:
None
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