Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346723
Status:
COMPLETED
Last Update Posted:
2009-01-30
First Post:
2006-06-29
Brief Title:
Annual Study to Investigate Inactivated Subunit Influenza Vaccine for the 20062007 Influenza Season in Europe
Sponsor:
Solvay Pharmaceuticals
Organization:
Solvay Pharmaceuticals
Study Overview
Official Title:
Immunogenicity and Reactogenicity of Trivalent Influenza Subunit Vaccine Influvac for the Season 20062007 An Open Baseline-Controlled Study in Two Groups of Healthy Subjects Adults and Elderly
Status:
COMPLETED
Status Verified Date:
2009-01
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:
Influenza flu viruses change continuously therefore also the parts of viruses used in influenza vaccines can vary from year to year In Europe manufacturersmarketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year The current study is a phase IIIa clinical trial with a commercially available vaccine Influvac supplied in pre filled syringes It is part of the ongoing clinical trial program for Influvac and will be done to assess the immunogenicity and safety and tolerability of next seasons trivalent influenza subunit vaccine in two groups of healthy subjects subjects aged 18 and 60 years and subjects 61 years of age elderly
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 |
|---|---|---|---|
| 2006-001300-37 | None | None | None |