Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza vaccine GSK2186877A formulation 1; Influenza vaccine GSK2186877A formulation 2; Fluarix
Intervention description: Intramuscular administration, 2 doses; Intramuscular administration, 1 dose; Intramuscular administration, 1 dose
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Influenza; Safety; Immunogenicity; Vaccine

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline
      Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age.

      This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The
      impacted sections are study design, outcome measures, intervention sections and number of
      subjects.
    

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.

        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 (drug or vaccine) 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 (seasonal or pandemic) 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 (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 prednisone >0.5 mg/kg of body weight, or equivalent.
             Inhaled and topical steroids are allowed.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  A family history of congenital or hereditary immunodeficiency.

          -  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 consumption of egg proteins.

          -  History of any neurological disorders or seizures (including febrile convulsion).

          -  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 (such as mild diarrhoea, mild upper respiratory
                  infection) 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.