Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix Quadrivalent
Intervention description: 1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 470.0
Sex: All
Minimum age: 17 Months
Maximum age: 48 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK Biologicals quadrivalent influenza vaccine; Influenza; Children; Safety; Immunogenicity

Summary:

      The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals'
      investigational vaccine GSK2321138A in children who previously participated in study 115345
      (FLU D-QIV-004 PRI) (NCT01439360).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with
             the requirements of the protocol.

          -  Children, male or female who received a 2-dose vaccination in the study 115345
             (NCT01439360).

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Subjects in stable health as determined by medical history and clinical examination
             before entering into the study.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza
             vaccine other than the study vaccines of study 115345 or planned administration of any
             influenza vaccine other than the study vaccine during the study.

          -  Administration of any vaccine not foreseen by the study protocol within 4 weeks
             preceding the first dose of study vaccine or planned use until Visit 2.

          -  Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within 6 months prior to enrolment in the study or planned
             administration during the study period. Inhaled and topical steroids are allowed.

          -  Administration of immunoglobulins and/ or any blood products within 3 months preceding
             the first dose of study vaccine or planned administration during the study period.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Any contraindication to intramuscular injection.

          -  Acute disease and/or fever at the time of enrollment:

               -  Fever is defined as temperature ≥ 37.5°C 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 other condition which, in the opinion of the Investigator, prevents the subject
             from participating in the study.