Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix™; Havrix™ Junior
Intervention description: One or two intramuscular injections; Two intramuscular injections
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 1 Year
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; H1N1; Fluarix; Pandemrix

Summary:

      This study is designed to assess the immunogenicity, reactogenicity and safety following
      vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been
      vaccinated with two doses of Pandemrix at the age of 6 months-9 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given
             at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of
             first vaccination.

          -  Subjects having received the last dose of Pandemrix at least six months prior to study
             enrolment.

          -  Subjects who the investigator believes that parent(s)/Legally Acceptable
             Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subjects.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Parent/LAR with access to a consistent means of telephone contact, land line or
             mobile, but NOT a pay phone or other multiple-user device.

        Exclusion Criteria:

          -  Active participation in other clinical trials.

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of the study vaccine or planned use 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
             three months prior to enrolment in this study or planned administration during the
             study period.

          -  Acute disease and/or fever at the time of enrolment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by medical history and physical examination.

          -  Administration of immunoglobulins and/or any blood products within the three months
             prior to the enrolment in this study, or planned use during the study.

          -  Any known or suspected allergy to any constituent of influenza vaccines; a history of
             anaphylactic-type reaction to any constituent of influenza vaccines; or a history of
             severe adverse reaction to a previous influenza vaccine.

          -  History of seizures or progressive neurological disease.

          -  Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having
             received the 2010/2011 seasonal influenza vaccine.

          -  Child in care.