Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01457027
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2011-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess Immunogenicity Parameters After Vaccination Against Influenza and to Evaluate How These Parameters Change During the Influenza Season
Sponsor:
Crucell Holland BV
Organization:
Study Overview
Official Title:
A Phase IV, Open Label Study to Evaluate the Short and Long Term Immune Response and CROSS-protection After Vaccination With viroSOME Adjuvanted Inflexal V in Elderly Subjects
Status:
COMPLETED
Status Verified Date:
2013-02
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:
A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: