Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT01100294
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
2010-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
Sponsor:
Fluart Innovative Vaccine Ltd, Hungary
Organization:
Study Overview
Official Title:
Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
Status:
COMPLETED
Status Verified Date:
2012-05
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:
To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.
Detailed Description:
This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated.
Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.
Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.
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?: