A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: Influenza A (H5N1) Virus Monovalent Vaccine
Intervention description: Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H5N1; immunogenicity; influenza; Avian; pandemic; vaccines; human; safety

Summary:

      The purpose of the study is to characterize the immunogenicity & safety of 2 doses of GSK's
      avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64
      years
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female 18-64 years old at the time of the first vaccination.

          -  Written informed consent obtained from the subject.

          -  Good general health as established by medical history and clinical examination before
             entering into the study.

          -  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.

          -  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 evidence of substance abuse or of neurological or psychiatric diagnoses
             which, even if clinically 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.

          -  Persons with a history of cancer who are disease-free without treatment for 3 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 excepted and may be enrolled, but
             other histological types of skin cancer are exclusionary.

          -  Women who are disease-free 3 years or more after treatment for breast cancer and
             receiving long-term prophylactic tamoxifen are excepted and may be enrolled.

          -  Presence of an oral temperature ≥37.8ºC, 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 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 or during the 30
             days following the last test article dose. Subjects who receive such immunizations on
             an emergent basis after enrollment will be followed per protocol and included in the
             Total Vaccinated Cohort (TVC), but excluded from the According to Protocol (ATP)
             Cohort for both safety and immunogenicity.

          -  Previous administration of any H5N1 vaccine.

          -  Use of any investigational or non-registered product (drug or vaccine) or planned
             participation in another investigational study within 30 days prior to study
             enrollment, or during the 182 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 6 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 (including egg
             proteins or mercurial preservatives); 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 (β-hCG) 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. Note: all
             women will have urine pregnancy tests regardless of their status.

          -  Known receipt of analgesic or antipyretic medication on the day of treatment with
             specific intent of prophylaxis of vaccine reactogenicity on the day of first or any
             treatment. Subjects on stable chronic regimens of potentially analgesic or
             anti-pyretic medications for pre-existing diagnoses are not required to discontinue
             them