Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506350
Status:
COMPLETED
Last Update Posted:
2017-10-04
First Post:
2007-07-24
Brief Title:
Evaluate Reactogenicity Immunogenicity of an Influenza Pandemic Candidate Vaccine GSK1562902A in Primed Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate the Reactogenicity Immunogenicity of 1 or 2 Booster Administrations of an Influenza Pandemic Candidate Vaccine GSK1562902A in Primed Adults Aged Between 19 61 Years
Status:
COMPLETED
Status Verified Date:
2017-09
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 present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine GSK1562902A in adults aged between 19 and 61 years previously vaccinated with 2 doses of a pandemic candidate vaccine Fifty new subjects who did not participate in a primary study 106750 NCT00309634 will be recruited This protocol posting deals with objectives outcome measures of the booster phase The objectives outcome measures of the primary phase are presented in a separate protocol posting NCT00309634
Detailed Description:
The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine GSK1562902A in adults aged between 19 and 61 years previously vaccinated with 2 doses of a pandemic candidate vaccine The persistence of antibodies will be analysed at 6 12 18 and 24 months
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