Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Intervention description: Intramuscular (IM), two doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H5N1; Influenza vaccine; influenza infection; GSK1557484A

Summary:

      This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A,
      prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when
      administered up to 5 years following production.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  A male or female 18 to 64 years of age at the time of the first vaccination.

          -  Written informed consent obtained from the subject.

          -  Stable general health as established by medical history and clinical examination
             before entering into the study.

          -  Subject 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 non-childbearing potential may be enrolled in the study.

          -  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 for 2 months after completion of
                  the vaccination series.

        Exclusion Criteria:

          -  Previous vaccination at any time with an H5N1 vaccine.

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.

          -  Presence of evidence of substance abuse or of neurological or psychiatric diagnoses
             which, even if stable, are deemed by the investigator to render the potential subject
             unable/unlikely to provide accurate safety reports.

          -  Presence of a temperature ≥ 38.0ºC, or acute symptoms greater than "mild" severity on
             the scheduled date of first dose.

          -  Diagnosed with cancer, or treatment for cancer, within 3 years.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Receipt of systemic glucocorticoids within 1 month prior to study enrolment, or any
             other cytotoxic or immunosuppressive drug within 6 months of study enrolment. Topical,
             intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors
             or imiquimod are allowed.

          -  Receipt of any immunoglobulins and/or any blood products within 3 months before first
             study vaccination 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 dosing, are eligible. Persons receiving prophylactic antiplatelet
             medications, and without a clinically-apparent bleeding tendency, are eligible.

          -  An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6
             weeks of receipt of seasonal influenza vaccine.

          -  Administration of an inactivated or a live, attenuated seasonal influenza vaccine
             within 14 days before the first study vaccine dose, or of any other vaccine(s) not
             foreseen by the study protocol within 30 days before the first study vaccine dose.

          -  Planned administration of any vaccine(s) not foreseen by the study protocol through
             completion of the Day 42 visit.

          -  Any known or suspected allergy to any constituent of influenza vaccines, or history of
             severe reaction to a previous influenza vaccination.

          -  Known pregnancy or a positive urine beta-human chorionic gonadotropin test result
             prior to the first study vaccine dose.

          -  Lactating or nursing women.