Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted; Placebo
Intervention description: Two intramuscular injections at Days 0 and 21.; Two intramuscular injections at Days 0 and 21.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4561.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccines; immunogenicity; human; safety; influenza

Summary:

      The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to
      characterize the immunogenicity & safety of the investigation vaccination regimen of GSK
      1557484A vaccine given to adults aged ≥18 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female 18 years of age or greater at the time of the first vaccination.

          -  Written informed consent obtained from the subject.

          -  Among 18 to 49 year old subjects, good general health as established by medical
             history and clinical examination before entering into the study.

          -  Among subjects > 49 years of age, stable health status within 1 month prior to
             enrollment.

          -  Access to a consistent means of telephone contact.

          -  Comprehension of the study requirements, ability to comprehend and comply with
             procedures for collection of short- and long-term safety data, expressed availability
             for the required study period, and ability and willingness to attend scheduled visits.

        Exclusion Criteria:

          -  Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if
             clinically stable, are deemed by the investigator to render the potential
             subjectunable/unlikely to provide accurate safety reports.

          -  Diagnosed with cancer, or treatment for cancer, within 3 years.

          -  An oral temperature ≥37.8º 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 infection.

          -  Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other
             cytotoxic or immunosuppressive drug within 6 months of study enrollment.

          -  Any significant disorder of coagulation or treatment with Coumadin derivatives or
             heparin.

          -  Administration of any vaccines within 30 days before study enrollment.

          -  Previous administration of any H5N1 vaccine.

          -  Use of any investigational or non-registered product or planned participation in
             another investigational study within 30 days prior to study enrollment, or during the
             364 days following the first test article dose. Use of any investigational or
             non-registered product with immunosuppressive properties is exclusionary at any time
             during the trial.

          -  Receipt of any immunoglobulins and/or any blood products within 3 months of study
             enrollment or planned administration of any of these products during the study period.

          -  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.

          -  Known pregnancy or a positive urine beta-human chorionic gonadotropin test result
             prior to either 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.

          -  Known use of an analgesic or antipyretic medication within 12 hours prior to first
             treatment.