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

Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) in Children 6 to 35 Months of Age

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.

The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to explore response to vaccination.

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.