Influenza Clinical Trial
Official title:
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
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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