Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: FluarixTM; HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)
Intervention description: One Intramuscular injection; Two Intramuscular injections
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Pandemrix; H1N1; Fluarix

Summary:

      This study is designed to assess the immunogenicity, reactogenicity and safety following
      vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been
      vaccinated with one dose of PandemrixTM at the age of 10-17 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects having previously been immunized with only one single dose of Pandemrix at
             the age of 10-17 years inclusive.

          -  Subjects having received Pandemrix at least six months prior to study enrolment.

          -  Subjects who the investigator believes that subject and/or parent(s)/Legally
             Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the
             protocol

          -  Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the
             subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Subjects or Parent(s)/LAR(s) 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:

          -  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 confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination

          -  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.

          -  If the subject is female and if she is of childbearing potential, she must practice
             adequate contraception for 30 days prior to vaccination, have a negative pregnancy
             test and continue such precautions for two months after completion of the vaccination
             series.

          -  Child in care.