Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310648
Status:
COMPLETED
Last Update Posted:
2006-09-14
First Post:
2006-04-03
Brief Title:
Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects 60 Years
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
Part 1Phase I Open-Label Single-Center to Evaluate the Safety of a Commercially Available Adjuvanted Influenza Vaccine When Administered to Elderly Subjects Part 2 A Phase III Randomized Controlled Observer-Blind Single-Center Study to Evaluate the Immunogenicity and Safety of a Commercially Available Influenza Vaccine and a Conventional Commercially Available Influenza Vaccine When Administered to Elderly Subjects
Status:
COMPLETED
Status Verified Date:
2006-09
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:
Clinical Trial in Two parts
Part 1 Phase I Open-Label Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects
Part 2 A Phase III Randomized Controlled Observer-blind Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects
Part 1 Phase I Open-Label Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects
Part 2 A Phase III Randomized Controlled Observer-blind Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects
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 |
|---|---|---|---|
| Part 2 200511-III | None | None | None |
| Part 1 200511-I | None | None | None |