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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Vaccination with Fluval AB suspension for injection
District Doctor's Office
Budapest, Hungary
District Doctor's Office
Pilisvörösvar, Hungary
District Doctor's Office
Szentendre, Hungary
Assessment of immunogenicity measures in comparison to criteria specified in CPMP/BWP/214/96
To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test in comparison to criteria specified in CPMP/BWP/214/96.
Time frame: 21-28 days after immunization
To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.
Safety and tolerability will be assessed in comparison to available safety and tolerability data on Fluval AB suspension for injection: * number and percentage of subjects with at least one local reaction between Day 0 and Day 21-28. * number and percentage of subjects with at least one systemic reaction between Day 0 and Day 21-28. * number and percentage of subjects with at least one adverse reaction between Day 0 and Day 21-28.
Time frame: From Day 0 until 21-28 days after immunization
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