Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343681
Status:
COMPLETED
Last Update Posted:
2014-01-17
First Post:
2006-06-21
Brief Title:
A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity and Safety of the Inactivated Split-Virion Influenza Vaccine Northern Hemisphere 2006-2007 Formulation Intramuscular Route
Status:
COMPLETED
Status Verified Date:
2014-01
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:
This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency
The objectives of the trial are
To evaluate the compliance in terms of immunogenicity of the inactivated split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency
To describe the safety of the inactivated split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation
The objectives of the trial are
To evaluate the compliance in terms of immunogenicity of the inactivated split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency
To describe the safety of the inactivated split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation
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