Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354016
Status:
COMPLETED
Last Update Posted:
2007-03-13
First Post:
2006-07-18
Brief Title:
Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine Using the Strain Composition 20062007 in Non-Elderly Adult and Elderly Subjects
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Phase III Multicenter Uncontrolled Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine Using the Strain Composition 20062007 When Administered to Non-Elderly Adult and Elderly Subjects
Status:
COMPLETED
Status Verified Date:
2007-03
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:
Due to antigenic changes of influenza viruses the virus strains used in influenza vaccines are adjusted every year according to WHO World Health Organization and CHMP Committee for Medicinal Products for Human Use recommendations Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects CPMPBWP21496
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT number 2006-000438-11 | None | None | None |