Safety of 4Fluart ID Suspension for Injection in Adult Subjects

Exclusion Criteria

• •Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study. Pregnancy with regard to the total duration of the study.
• •Hypersensitivity to the active substances or to any of the excipients, such as thiomersal, or any component that may be present in traces, such as egg (ovalbumin), formaldehyde, gentamicin, neomycin, vancomycin or ciprofloxacin determined prior to vaccination;
• •Serious complications in the medical history with regard to any previous vaccination: encephalitis/encephalopathy, nonfebrile seizures, Guillain-Barré syndrome, vasculitis, neuritis, facial paresis determined prior to vaccination;
• •History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine determined prior to vaccination;
• •Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure with regard to the total duration of the study;
• •Immunosuppressive therapy within 36 months prior to vaccination and with regard to the total duration of the study;
• •Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids with regard to the total duration of the study;
• •Receipt of immunostimulants with regard to the total duration of the study;
• •Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination and with regard to the total duration of the study;
• •Suspected or known HIV, Hepatitis-B virus (HBV) or Hepatitis-C virus (HCV) infection with regard to the total duration of the study;
• •Acute disease and/or axillary temperature ≥37oC within 3 days prior to vaccination;
• •Vaccine therapy within 4 weeks prior to vaccination and with regard to the total duration of the study;
• •Influenza vaccination (any kind) within 6 months prior to vaccination and with regard to the total duration of the study;
• •Experimental drug therapy within 4 weeks prior to vaccination and with regard to the total duration of the study;
• •Concomitant participation in another clinical study;
• •Any condition which, may interfere with the evaluation of the study (including major protocol deviation with regard to the total duration of the study);
• •Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have an effect on the objective decision-making of the volunteer;
• •Alcohol or drug abuse of the participant.