Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-03 @ 8:40 PM
Study NCT ID:
NCT02126761
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2014-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Different Formulations of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects 65 Years of Age and Above
Sponsor:
Seqirus
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Observer Blind, Antigen and Adjuvant Dosage-Finding Study to Evaluate the Safety and Immunogenicity of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects ≥65 Years of Age
Status:
COMPLETED
Status Verified Date:
2015-12
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:
In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in independently-living elderly subjects ≥ 65 years of age.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-005344-29 | EUDRACT_NUMBER | None | View |