Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Quadrivalent Influenza Vaccine (split virion, inactivated)
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Quadrivalent Inactivated Influenza Vaccine

Summary:

      The aim of the study is to describe the immunogenicity and safety of the new formulation of
      Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH)
      in subjects aged 9 to 17 years in Taiwan

      Primary Objective:

        -  To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal
           formulation

      Secondary Objective:

        -  To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 9 to 17 years on the day of inclusion

          -  Assent form (AF) and/or informed consent form (ICF) have been signed and dated by the
             subject according to each site requirements, and ICF has been signed and dated by the
             parent(s) or another legally acceptable representative(s) and by an independent
             witness if applicable

          -  Subject and parent/legally acceptable representative are able to attend all scheduled
             visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Subject is pregnant (or positive urine pregnancy test), or lactating, or of
             childbearing potential (to be considered of non-childbearing potential, a female must
             be post-menopausal for at least 1 year, surgically sterile, or using an effective
             method of contraception or abstinence from at least 4 weeks prior to vaccination and
             until at least 4 weeks after vaccination)

          -  Participation at the time of study enrollment or in the 4 weeks preceding the trial
             vaccination or planned participation during the present trial period in another
             clinical trial investigating a vaccine, drug, medical device, or medical procedure

          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned
             receipt of any vaccine in the 3 weeks following trial vaccination

          -  Vaccination against influenza in the previous 12 months if administered in the context
             of a clinical trial or in the previous 6 months if administered in the context of a
             flu vaccination campaign

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
             within the preceding 6 months; or long-term systemic corticosteroid therapy
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

          -  Self-reported history of seropositivity for Human Immunodeficiency Virus (HIV),
             Hepatitis B, or Hepatitis C, after questioning

          -  Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and
             octoxynol-9, or to any of the vaccine components, or history of a life-threatening
             reaction to the vaccine used in the study or to a vaccine containing any of the same
             substances

          -  Known or suspected thrombocytopenia, contraindicating intramuscular vaccination based
             on investigator's judgment

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination upon investigator's judgment

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Current alcohol abuse or drug addiction

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (temperature ≥38.0°C). A prospective subject
             should not be included in the study until the condition has resolved or the febrile
             event has subsided

          -  Identified as a family member (i.e., parent, spouse, natural or adopted child) of the
             Investigator or employee with direct involvement in the proposed study.