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

Inclusion criteria

Male and female 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 (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);
• 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

• have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;
• have received any vaccination within 2 weeks prior to vaccination in this study;
• suffer from any kind of immunodeficiency;
• suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response;
• have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
• have received a blood transfusion or immunoglobulins within 30 days of study entry;
• have donated blood or plasma within 30 days of study entry;
• have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications);
• have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
• have a known or suspected problem with alcohol or drug abuse;
• are unable to lead an independent life as a result of either physical or mental handicap;
• were administered an investigational drug within six weeks prior to study entry;
• are concurrently participating in a clinical study that includes the administration of an investigational product;
• if female, are pregnant or lactating;
• 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.