Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Arepanrix™
Intervention description: Intramuscular administration, one dose
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: elderly; post-marketing; H1N1; Clinical trial; pandemic influenza

Summary:

      The purpose of this study is to comply with the post marketing condition to the exceptional
      approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK
      Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male and female adults 65 years of age or older at time of vaccination.

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  Written informed consent obtained from the subject.

          -  Good general health as assessed by medical history and physical examination.

          -  Access to a consistent means of telephone contact, which may be either in the home or
             at the workplace, land line or mobile, but NOT a pay phone or other multiple-user
             device.

          -  Female subjects of non-childbearing potential may be enrolled in the study.
             Non-childbearing potential is defined as current tubal ligation, hysterectomy,
             ovariectomy or post-menopause.

          -  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 and for 2 months after study
                  vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the dose of study vaccine, or planned use during the study period.

          -  History of previous administration of a pandemic H1N1 vaccine.

          -  Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.

          -  Presence or evidence of substance abuse or of neurological or psychiatric diagnoses
             which, although stable, are deemed by the investigator to render the potential subject
             unable/unlikely to provide accurate safety reports.

          -  Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild"
             severity on the scheduled date of vaccination.

          -  Diagnosed with cancer, or treatment for cancer within three years.

               -  Persons with a history of cancer who are disease-free without treatment for three
                  years or more are eligible.

               -  Persons with a history of histologically-confirmed basal cell carcinoma of the
                  skin successfully treated with local excision only are accepted and may enrol,
                  but other histologic types of skin cancer are exclusionary.

               -  Women who are disease-free three years or more after treatment for breast cancer
                  and receiving long-term prophylactic tamoxifen are excepted and may enroll.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
             history of human immunodeficiency virus (HIV) infection.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune modifying drugs within 6 months of study enrolment or planned
             administration during the study period. For corticosteroids, this will mean a dose
             equivalent to 10 mg/day of prednisone or equivalent when administered for > 2 weeks.
             Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin
             inhibitors or imiquimod are allowed.

          -  Receipt of any immunoglobulins and/or any blood products within three months of study
             enrolment or planned administration of any of these products during the study period.

          -  Any significant disorder of coagulation or treatment with warfarin derivatives or
             heparin. Persons receiving individual doses of low molecular weight heparin outside of
             24 hours prior to vaccination are eligible. Persons receiving prophylactic
             antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent
             bleeding tendency, are eligible.

          -  An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6
             months of receipt of seasonal influenza vaccination.

          -  Administration of any vaccines within 30 days before vaccination or planned
             administration before blood sampling at Day 21 and within 30 days prior to blood
             sampling at Day 182.

          -  Any known or suspected allergy to any constituent of influenza vaccines or component
             used in the manufacturing process of the study vaccine; a history of anaphylactic-type
             reaction to consumption of eggs; or a history of severe adverse reaction to a previous
             influenza vaccine.

          -  Excessive underweight [Body Mass Index (BMI) < 18.5] or excessive obesity (BMI >= 30).

          -  Any conditions which, in the opinion of the investigator, prevents the subjects from
             participating in the study.

          -  Clinically or virologically confirmed influenza infection within 12 months preceding
             the study start.