Clinical Drug Experience Knowledgebase

Criteria

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.