Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection
Condition: Influenza Prophylaxis
MeSH terms: Influenza, Human
Intervention: Vaccination with Fluval AB suspension for injection
Intervention description: Single intramuscular injection with Fluval AB suspension for injection in both age groups
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel-group, in two age groups
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: uncontrolled; open; multi-centre; immunogenicity and tolerability; two groups according to age (18-59 years and ≥60 years)

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult persons aged 18 to 59 years, elderly persons aged ≥60 years from both sexes,
             mentally competent;

          -  Are in good health (as determined by vital signs and existing medical condition) or
             are in stable medical condition. Subjects will not be excluded with known adequately
             treated clinically significant organ or systemic diseases (e.g. asthma or diabetes),
             such that, in the opinion of the investigator, the significance of the disease will
             not compromise the subject's participation in the study;

          -  Female volunteers aged 18-59 years (i.e. participants of childbearing potential) with
             a negative result from the urine pregnancy test prior to vaccination who agrees to use
             an acceptable contraception method or abstinence throughout the trial and not become
             pregnant for the duration of the study;

          -  Capability of participants to understand and comply with planned study procedures;

          -  Participants provide written Informed Consent (IC) prior to initiation of study
             procedures;

          -  Absence of existence of any exclusion criteria.

        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.

          -  Known hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin,
             ciprofloxacin, neomycin, vancomycin or any other component of the vaccine;

          -  History of Guillain-Barré syndrome;

          -  History of neurological symptoms or signs, or anaphylactic shock following
             administration of any vaccine;

          -  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;

          -  Immunosuppressive therapy within 36 months prior to vaccination;

          -  Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;

          -  Receipt of immunostimulants;

          -  Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3
             months prior to vaccination;

          -  Suspected or known HIV, HBV or HCV infection;

          -  Acute disease and/or axillary temperature ≥37oC within 3 days prior to vaccination;

          -  Vaccine therapy within 4 weeks prior to vaccination;

          -  Influenza vaccination (any kind) within 6 months prior to vaccination;

          -  Experimental drug therapy within 4 weeks prior to vaccination;

          -  Concomitant participation in another clinical study;

          -  Any condition which, in the opinion of the investigator, may interfere with the
             evaluation of the study;

          -  Past or current psychiatric disease of the volunteer that upon judgement of the
             investigator may have effect on the objective decision-making of the volunteer;

          -  Alcohol or drug abuse of the participant.