Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

Exclusion Criteria

• •Presence or evidence 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.
• •Presence of a temperature ≥ 38.0ºC (≥100.4ºF) or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
• •NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
• •Significant risk of complications from intramuscular injections due to disorder of coagulation. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. Assessment of risk of injection complications should be made in the context of individual subject risk of H5N1 virus infection.
• •An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
• •Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine.
• •Planned administration of any vaccine other than the study vaccine before Day 42.
• •Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including 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 before the first vaccination.
• •Lactating or nursing women.
• •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.