Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

Inclusion Criteria: Male and femal subjects who are 18 to 45 years of age, inclusive, on the day of screening; have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry; are clinically healthy, as determined by medical history and physical examination; agree to keep a daily record of symptoms; if female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Subjects who are at high risk of contracting H5N1 influenza infection (e.g. poultry workers); suffer from a significant neurological, cardiac, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological or renal disorder; are unable to lead an independent life as a result of either physical or mental handicap; suffer from any kind of immunodeficiency; suffer from a disease or are undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs; have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré); have a history of severe allergic reactions or anaphylaxis; have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating; have received a blood transfusion or immunoglobulins within 90 days of study entry; have donated blood or plasma within 30 days of study entry; have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study; have undergone systemic corticoid therapy within 30 days prior to study entry; have a functional or surgical asplenia; have a known or suspected problem with alcohol or drug abuse; were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product; are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator; if female, are pregnant or lactating.