Clinical Drug Experience Knowledgebase

Criteria

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.