Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human
Intervention: GSK Bio's influenza vaccine GSK2584786A, different formulations; GSK Bio's influenza vaccine GSK2321138A; Fluarix™
Intervention description: Intramuscular injections; Intramuscular injections; Intramuscular injections
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: immunogenicity; safety; Influenza; children; vaccine

Summary:

      The purpose of this observer-blind study is to evaluate the safety and immunogenicity of
      GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months
      of age.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  Subjects who the investigator believes that parent(s)/Legally Acceptable
             Representative(s) [LAR(s)] can and will comply with the requirements of the protocol

          -  Children, 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.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Age appropriate scheduled childhood vaccinations completed to the best of
             parent(s)/LAR(s) knowledge.

          -  Born after gestation period of 36 to 42 weeks inclusive

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If ANY exclusion
        criterion applies, the subject must not be included in the study:

          -  Child in "care"

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Prior receipt of any influenza vaccination or planned administration during the study
             period.

          -  Planned administration of any vaccine 30 days prior and 30 days after any study
             vaccine administration.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  A family history of congenital or hereditary immunodeficiency.

          -  A family history of febrile seizures or/and epilepsy

          -  Any known or suspected allergy to any constituent of influenza or routine paediatric
             vaccines, a history of severe adverse reaction to any previous vaccination; or a
             history of anaphylactic-type reaction to any constituent of influenza vaccine.

          -  History of any progressive neurological disorders or seizures.

          -  Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by medical history or physical examination.

          -  Acute disease and/or fever at the time of enrolment:

          -  - Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or
             ≥38.0°C on rectal setting.

          -  Subjects with a minor illness without fever might be enrolled at the discretion of the
             investigator.

          -  Administration of immunoglobulins and/or any blood products within the 3 month
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Any condition which, in the opinion of the investigator, render the subject unfit for
             participation in the study.