Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: FluLaval® Quadrivalent; Fluzone®
Intervention description: 1 or 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.; 1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 316.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Immunogenicity; Fluzone®; 6 to 35 months of age; Seasonal influenza; Safety

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of the new influenza
      vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV)
      in children 6 to 35 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
             of the investigator, can and will comply, with the requirements of the protocol.

          -  A male or female between, and including, 6 and 35 months of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Subjects in stable health as determined by investigator's clinical examination and
             assessment of subject's medical history.

          -  Subjects are eligible regardless of history of administration of influenza vaccine in
             a previous season.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period. Routine registered childhood vaccinations are permitted.

          -  Child in care.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose. For corticosteroids, this will mean
             prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

          -  Prior receipt of any seasonal or pandemic influenza vaccine within six months
             preceding the first dose of study vaccine, or planned use during the study period.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  History of Guillain-Barré syndrome within six weeks of receipt of prior influenza
             vaccine.

          -  Any known or suspected allergy to any constituent of influenza vaccines; a history of
             anaphylactic-type reaction to consumption of eggs; or a history of severe adverse
             reaction to a previous influenza vaccine.

          -  Acute disease and/or fever at the time of enrollment.

               -  Fever is defined as temperature ≥ 38.0°C/100.4°F by any method.

               -  Subjects with a minor illness without fever may be enrolled at the discretion of
                  the investigator.

          -  Any significant disorder of coagulation or treatment with warfarin derivatives or
             heparin.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Any other condition which, in the opinion of the investigator, prevents the subject
             from participating in the study.