The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
110
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
CROSS Research S.A. - Phase I Unit
Arzo, Switzerland
Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT)
Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain: * Seroconversion rate at Day 22 has to be \>40% of subjects aged ≥18 to ≤60 years and \>30% of subjects aged \>60 years, or * Seroprotection rate at Day 22 has to be \>70% of subjects aged ≥18 to ≤60 years and \>60% of subjects aged \>60 years, or * GMT-fold increase at Day 22 compared to baseline: a \>2.5-fold increase has to be reached in subjects aged ≥18 to ≤60 years and a \>2.0-fold increase has to be reached in subjects aged \>60 years
Time frame: Day 22 +/- 2 days
Incidence of solicited local adverse events
Time frame: Days 1 to 4 inclusive
Incidence of solicited systemic adverse events
Time frame: Days 1 to 4 inclusive
Incidence of unsolicited adverse events
Time frame: Days 1 to 22 inclusive
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