Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Intervention description: All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Safety; Pandemic Influenza

Summary:

      This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK
      Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male and female adults 20 to 64 years of age at time of the first
             vaccination, inclusive.

          -  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.

          -  Written informed consent obtained from the subject.

          -  Comprehension of the study requirements, expressed availability for the required study
             period, and ability to attend scheduled visits.

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

        Exclusion Criteria:

          -  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.

          -  Diagnosed with cancer, or treatment for cancer within 3 years.

          -  Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild"
             severity on the scheduled date of first vaccination.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
             history of human immunodeficiency virus (HIV) infection.

          -  Receipt of systemic glucocorticoids within 1 month of study enrolment, or any other
             cytotoxic or immunosuppressive drug within 6 months of study enrolment.

          -  Any significant disorder of coagulation or treatment with Coumadin derivatives or
             heparin.

          -  Administration of any registered vaccine within 30 days before study enrolment 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.

          -  Use of any investigational or non-registered product within 30 days prior to study
             enrolment or planned use during the study period.

          -  History of previous H5N1 vaccination, or history of H5N1 influenza infection.

          -  Receipt of any immunoglobulins and/or any blood products within 6 months of study
             enrolment or planned administration of any of these products during the study period.

          -  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.

          -  Known pregnancy or a positive urine beta-human chorionic gonadotropin test result
             prior to the time of first vaccination.

          -  Lactating or nursing.

          -  Women of child-bearing potential who lack a history of reliable contraceptive
             practices. The provision of this history does NOT replace the requirement to perform,
             and obtain negative results in pregnancy urine tests prior to treatments; all women
             will have urine pregnancy tests regardless of their status.

          -  Known receipt of analgesic or antipyretic medication on the day of treatment (Day 0).