Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306995
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2006-02-16
Brief Title:
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Open Randomized Multicenter Comparative Vaccination Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of a Monovalent Candidate Pandemic Influenza A Vaccine in Individuals Over 60 Years of Age
Status:
COMPLETED
Status Verified Date:
2020-02
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:
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity If such virus is pathogenic to human and demonstrates the ability to transmit from person to person the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world Recently purely avian influenza viruses including the H5N1 H9N2 and H7N7 subtypes have been directly transmitted to humans raising concern over the possibility of a new influenza pandemic among the worlds immunologically naive populations In order to face this kind of situation a pandemic influenza vaccine has to be developed
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