NCT01010893

Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Fluart Innovative Vaccine Ltd, Hungary · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Vaccination with Fluval P and Fluval AB influenza vaccines	Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).
BIOLOGICAL	Vaccination with Fluval P monovalent influenza vaccine	Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-09-01
• Completion: 2010-02-01
• First posted: 2009-11-10
• Last updated: 2012-05-21

Locations

2 sites across 1 country: Hungary