Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004

Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) in Comparison to a Licensed Egg-derived Influenza Vaccine for Season 2003/2004

The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.

Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

• are >= 18 and <= 60 years old (for Stratum A only);
• are > 60 years old (for Stratum B only);
• are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial;
• will reliably keep a daily record of symptoms;
• understand the nature of the study, agree to its provisions, and give written informed consent;
• if female and capable of bearing children - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Male and female subjects will be excluded from participation in this study if they:

• have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 season;
• 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, chemotherapeutics) that can be expected to influence immunological functions;
• have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
• have received a blood transfusion or immunoglobulins within one month of study entry;
• have a history of any vaccine-related contraindicating event (e.g. anaphylaxis);
• have a rash or dermatological condition which may interfere with injection site reaction rating;
• have a known or suspected problem with drug or alcohol abuse;
• are unable to lead an independent life either physically or mentally;
• had administration of an investigational drug within six weeks prior to the study start;
• are concurrently participating in a clinical trial;
• are pregnant or lactating.