Immunogenicity and Safety of Pandemic Influenza Vaccines in Adults Aged 18 - 49 Years Old
Immunogenicity and Safety of Pandemic Influenza Vaccines in Adults Aged 18 - 49 Years Old
This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate
 vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.
Inclusion Criteria:

 -  Subjects who the investigator believes can and will comply with the requirements of
 the protocol.

 -  Written informed consent obtained from the subject.

 -  Male and female adults, 18-49 years of age at the time of the first vaccination.

 -  Satisfactory baseline medical assessment by history and physical examination.

 -  Safety laboratory test results within the parameters specified in the protocol.

 -  Access to a consistent means of telephone contact

 -  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
 urine pregnancy test on the day of first 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:

 -  Medical history of physician-confirmed infection with an H5N1 virus.

 -  Increased risk of occupational exposure to H5N1 influenza viruses.

 -  Previous vaccination at any time with an H5N1 vaccine, or with an oil-in water
 adjuvanted influenza vaccine.

 -  Planned administration of an adjuvanted influenza vaccine or an H5N1 pandemic vaccine
 during the entire study period.

 -  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.

 -  Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.

 -  Presence 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.

 -  Evidence of current substance abuse, including alcohol, by medical history.

 -  Presence of a temperature >= 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild"
 severity on the scheduled date of first dose.

 -  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.

 -  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 enrollment, or any
 other cytotoxic or immunosuppressive drug within 6 months of study enrollment.

 -  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 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.

 -  An acute evolving neurological disorder or history of Guillain-Barré syndrome.

 -  Administration of an inactivated 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. The administration of
 live attenuated trivalent seasonal influenza virus vaccine (LAIV) is allowed.

 -  Planned administration of any vaccine(s) not foreseen by the study protocol through
 completion of the Day 42 visit. The administration of LAIV is allowed.

 -  Any known or suspected allergy to any constituent of influenza vaccines or to latex,
 or history of severe reaction to a previous influenza vaccination.

 -  Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test
 result prior to the first study vaccine dose.

 -  Lactating or nursing women.