NCT01404182

Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine in Adults and Elderly Persons

Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine (Trivalent, Seasonal, Active Ingredient Content: 15 μg HA/Strain/0.5 mL) in Adults and Elderly Persons

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Fluart Innovative Vaccine Ltd, Hungary · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB trivalent influenza vaccine in adults and elderly people.

Detailed description

Immunogenicity Objective: To assess immunogenicity of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test. Safety and Tolerability Objectives: To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Vaccination with Fluval AB influenza vaccine	Vaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant.

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-07-27
• Last updated: 2012-05-21

Locations

2 sites across 1 country: Hungary