Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT01306305
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2011-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere
Sponsor:
Crucell Holland BV
Organization:
Study Overview
Official Title:
Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2010/2011-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations
Status:
COMPLETED
Status Verified Date:
2013-08
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 assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines
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?: