Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT01010893
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
2009-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine
Sponsor:
Fluart Innovative Vaccine Ltd, Hungary
Organization:
Study Overview
Official Title:
Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons
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 immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.
Detailed Description:
Primary Objective:
To assess tolerability/safety (incidence of adverse events) of the study drug. To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and age groups.
Secondary Objectives:
To assess the long-term safety of the study drug 50-60 days after immunization. To determine the tolerability of simultaneous administration of FLUVAL P monovalent pandemic influenza vaccine and FLUVAL AB trivalent seasonal influenza vaccine in case of adults and elderly people.
To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season.
To assess the immunogenicity of the study drug by optional cross-reactive immunity tests performed with non-homologous influenza A and B virus strains.
To assess tolerability/safety (incidence of adverse events) of the study drug. To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and age groups.
Secondary Objectives:
To assess the long-term safety of the study drug 50-60 days after immunization. To determine the tolerability of simultaneous administration of FLUVAL P monovalent pandemic influenza vaccine and FLUVAL AB trivalent seasonal influenza vaccine in case of adults and elderly people.
To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season.
To assess the immunogenicity of the study drug by optional cross-reactive immunity tests performed with non-homologous influenza A and B virus strains.
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?: