Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)
Intervention description: Two intramuscular injections
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK Bio's influenza vaccine GSK2340274A; influenza infection

Summary:

      The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational influenza vaccine GSK2340274A following one dose and following a second dose,
      using the same dosage as has been used in the H5N1 development program in Japanese children
      aged 10-17 years and an alternative dose in children aged 6 months to 9 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol.

          -  Japanese children, male or female, aged between 6 months and 17 years at the time of
             the first study vaccination.

          -  Written informed consent obtained from the subject's parent(s) or LAR(s) of the
             subject. Whenever possible, an assent should also be obtained from the subject.

          -  Healthy children as established by medical history and clinical examination when
             entering into the study (Particular attention must be exercised when dealing with
             patients with bronchial asthma).

          -  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.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject: has practiced adequate contraception for 30 days prior to vaccination, and
             has a negative pregnancy test on the day of vaccination, and has agreed to continue
             adequate contraception during the entire treatment period and for 2 months after
             completion of the vaccination series.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the first dose of the study vaccine or planned
             use during the study period.

          -  Clinically or virologically confirmed influenza infection from May 2009 to the day of
             enrolment.

          -  Previous administration of a novel [H1N1]v vaccine.

          -  Administration of any vaccines within 30 days before vaccination or planned
             administration within the first vaccination up to blood sampling at Day 42 and within
             30 days prior to blood sampling at Day 182, with the exception of seasonal influenza
             vaccine.

          -  Administration of any seasonal influenza vaccine within 14 days before vaccination on
             Day 0, or planned administration within the first vaccination up to blood sampling at
             Day 42 and within 14 days prior to blood sampling at Day 182.

          -  Excessive underweight or excessive obesity. (Under or upper 2-fold standard deviation
             of weight distribution that are corresponding age group are used as reference).

          -  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:

          -  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 may be enrolled at the discretion of the investigator.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination (no laboratory testing required).

          -  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 during the study.

          -  Any known or suspected allergy to any constituent of influenza vaccines; a history of
             anaphylactic-type reaction to consumption of eggs; or a history of severe adverse
             reaction to a previous influenza vaccine.

          -  History of any neurological disorder including acute disseminated encephalomyelitis
             and Guillain-Barré syndrome, or convulsive seizures and epilepsy.

          -  Any significant disorder of coagulation or treatment with warfarin derivatives or
             heparin. Persons receiving individual doses of low molecular weight heparin are
             eligible if no such doses are given in the 24 hours before a study vaccination.
             Persons receiving prophylactic antiplatelet medications, e.g., low-dose
             acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are
             eligible

          -  Any conditions which, in the opinion of the investigator, prevents the subject from
             participating to the study.

          -  Child in Care.