Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents
Condition: Human Influenza
MeSH terms: Influenza, Human
Intervention: Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml); Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)
Intervention description: vaccination; vaccination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: parallel-group study in two paediatric age groups
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: immunogenicity; reduced dose; Phase III; tolerability; safety

Summary:

      Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent,
      seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children
      and Adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 3 to 11 years, adolescents aged 12 to 18 years from both sexes;

          -  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 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 adolescent participants aged 12 to 18 years and the legitimate
             representative of all volunteers to understand and comply with planned study
             procedures;

          -  Adolescent participants aged 12 to 18 years and the legitimate representative of all
             volunteers 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, 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 or the legitimate representative
             that upon judgement of the investigator may have effect on the objective
             decision-making of the volunteer;

          -  Alcohol or drug abuse of the participant or the legitimate representative.