Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: FluLaval™ Quadrivalent; Fluzone® Quadrivalent
Intervention description: 1 or 2 doses administered intramusculary (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 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 2432.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fluzone Quadrivalent; Comparator; Children; Seasonal influenza; Safety; Immunogenicity

Summary:

      The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'
      quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone®
      Quadrivalent 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 (drug or vaccine) 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 (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within six months prior to the first vaccine dose. For
             corticosteroids, this will mean a dose equivalent to either > 2 mg/kg/day of body
             weight, or to ≥ 20 mg/day of prednisone for persons who weigh ≥ 10 kg, when
             administered for more than 2 weeks. Inhaled and topical steroids are allowed.

          -  Prior receipt of any seasonal or pandemic influenza vaccine (registered or
             investigational) 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 (including egg
             proteins); 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 enrolment.

               -  Fever is defined as temperature ≥ 38.0°C/100.4°F by any route.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) 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.