Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT03437304
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2018-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults
Sponsor:
Eurocine Vaccines AB
Organization:
Study Overview
Official Title:
A Phase I/II, Randomised, Multicentre, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults (Age 50 to 75 Years)
Status:
COMPLETED
Status Verified Date:
2018-12
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:
This is a Phase I/II, randomised, multicentre, partially double-blind (group 1, 2, 4 and 5), parallel-group study designed to primarily evaluate the safety, tolerability and immune response in older adults (age 50 to 75 years) following Immunose™ FLU vaccination at 5 sites in Sweden. A total of 300 subjects will be randomised to 1 of 7 treatment groups. The hypothesis is that Immunose™ FLU is safe and tolerable and will increase the influenza-specific mucosal immune response in older adults.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: