Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza investigational vaccine GSK2340274A
Intervention description: Two intramuscular injections on Day 0 and Day 21, respectively
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
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: influenza infection; GSK Biologicals' influenza vaccine GSK2340272A

Summary:

      This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK
      Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged
      20-64 years.
    

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

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  Written informed consent obtained from the subject.

          -  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.

          -  Females of non-childbearing potential may be enrolled in the study.

          -  Female of childbearing potential may be enrolled in the study, if she:

          -  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 other than the study vaccine(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  History of previous administration of a novel [H1N1]v vaccine.

          -  Previous participation in study NCT00742885.

          -  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 first vaccination.

          -  Diagnosed with cancer, or treatment for cancer within 3 years.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
             history of human immunodeficiency virus (HIV) infection.

          -  Chronic administration of immunosuppressants or other immune modifying drugs within 6
             months of study enrolment or planned administration during the study period.

          -  Receipt of any immunoglobulins and/or any blood products within 3 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.

          -  An acute evolving neurological disorder or history of Guillain-Barré syndrome.

          -  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.

          -  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 any constituent of influenza vaccines; or a history of severe adverse
             reaction to a previous influenza vaccine.

          -  Known pregnancy or a positive urine test result prior to the time of first
             vaccination.

          -  Lactating or nursing female.

          -  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 6 months preceding
             the study start.