A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64
A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64
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
A Phase 2, open-label, randomized, parallel group, multi-centered study designed to evaluate
 the immunogenicity and safety of a 2-dose series of avian influenza vaccine plus AS03
 adjuvant according to different regimens, in adults aged 18-64 years. All subjects will
 receive active study vaccine; no subjects are to receive placebo. A total of 312 subjects
 will be enrolled in this study at approximately 3 study centers in Canada. All subjects will
 attend formal study center visits for safety and immunogenicity assessments on Days 0, 21,
 42, and 182. Additional formal study center visits will be scheduled at additional timepoints
 for subjects in particular dose groups. In addition, a telephone call will be conducted for
 all subjects on Day 51
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