Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00491985
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2007-06-26
Brief Title:
Safety and Immunogenicity of 2 Formulations of an Intramuscular AH5N1 Pandemic Influenza Vaccine in Children
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
None
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 is an open randomized multicenter clinical trial
Objectives
To describe the safety profiles during the 21 days following each primary and booster injection
To describe the immune response 21 days after each primary and booster injection of each formulation
To describe the antibody persistence after the first vaccination
Objectives
To describe the safety profiles during the 21 days following each primary and booster injection
To describe the immune response 21 days after each primary and booster injection of each formulation
To describe the antibody persistence after the first vaccination
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