A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Quadrivalent seasonal influenza vaccine GSK2282512A; Fluarix™ VB; Fluarix™ YB; Quadrivalent seasonal influenza vaccine GSK2282512A
Intervention description: For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.; For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.; For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose; Single intramuscular dose for primed subjects, two doses for unprimed subjects.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3109.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      This study is designed to test the immunogenicity and safety of an investigational influenza
      vaccine, in children compared to two other influenza vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parent(s) or legally
             acceptable representative(s) can and will comply with the requirements of the
             protocol.

          -  A male or female child aged between 6 months and 17 years inclusive at the time of the
             first vaccination; children are eligible regardless of history of administration of
             influenza vaccine in a previous season.

          -  Written informed consent obtained from the subject/from the parent(s)/legally
             acceptable representative(s) of the subject.

          -  Written informed assent obtained from the subject if/as required by local regulations.

          -  Subjects in stable health as determined by investigator's clinical examination and
             assessment of subjects' medical history.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Female subjects of childbearing potential may be enrolled in the study, if the subject

               -  Has practiced adequate contraception for 30 days prior to vaccination, and

               -  Has a negative pregnancy urine test on the day of vaccination, and

               -  Has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the vaccination series.

        Exclusion Criteria:

          -  Child in care

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6
             months preceding the first dose of study vaccine, or planned use during the study
             period.

          -  Chronic administration of immunosuppressants or other immune modifying drugs within
             six months prior to the first vaccine dose.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  History of Guillain-Barré syndrome within 6 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.

          -  Fever at the time of enrolment.

          -  Acute disease at the time of enrolment.

          -  Any significant disorder of coagulation or treatment with Coumadin derivatives or
             heparin.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Ongoing aspirin therapy.

          -  Any other condition which, in the opinion of the Investigator, prevents the subject
             from participating in the study.