NCT01649713

Yearly Licence Tolerability and Immunogenicity Study of Fluval AB Seasonal Influenza Vaccine to be Used in the 2012/2013 Vaccination Season

Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 15 ugHA/Strain/0.5mL) in Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Fluart Innovative Vaccine Ltd, Hungary · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection, as measured by haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.

Detailed description

For the 2011-2012 vaccination season the following influenza virus strains were recommended to be included in the influenza vaccines: * A/California/7/2009(H1N1)-like virus, * A/Perth/16/2009(H3N2)-like virus, * B/Brisbane/60/2008-like virus. For the 2012-2013 season the following strains were recommended (Amended EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2012/2013, EMA/CHMP/BWP/140597/2012): * A/California/7/2009(H1N1)-like virus, * A/Victoria/361/2011(H3N2)-like virus, * B/Wisconsin/1/2010-like virus. Since the A/H3N2 and the B virus strains were changed, a yearly licence clinical study have to be performed.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Fluval AB vaccination	Vaccination with Fluval AB suspension for injection

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-07-25
• Last updated: 2012-10-12

Locations

3 sites across 1 country: Hungary