Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

able to understand the study and provide written informed consent
be age 18 to 49 years
be in good general health, without significant medical history, physical examination findings, or abnormal laboratory results
be available for the study duration, including all planned follow-up visits
female subjects of child bearing potential must not be pregnant and agree to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before the study and during the study

Exclusion Criteria:

have allergy to eggs or other components of the vaccine
have had an influenza vaccine within 3 years preceding the screening visit
have a history of severe reaction of any kind to conventional influenza vaccines
have or suspected immunodeficiency disorder, including leukemia, lymphoma, generalized malignancy, or treatment with immunosuppressive medications, including corticosteroids, alkylating agents, antimetabolites, or radiation therapy
have a history of an autoimmune disorder, including systemic lupus, rheumatoid arthritis, scleroderma, other collagen vascular disease, multiple sclerosis, etc. Psoriasis limited to cutaneous manifestations is not an exclusion criterion.
have prior history of anaphylaxis to foods, hymenoptera stings, vaccines or drugs
have had transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within 3 months of the Screening Visit or anticipated through the study period
have received another vaccine within 30 days preceding the screening visit or anticipated through the study period
have participation in another clinical trial within 60 days of the screening visit
have a positive serum or urine pregnancy test prior to vaccination or plan on a pregnancy during study period
have abnormalities on laboratory assessment
be seropositive to HIV or HCV or positive for HBsAg
be positive for anti-nuclear antibodies
have a physical examination indicating any clinically significant medical condition
have a body temperature >38.1°C (100.6°F) or acute illness within 3 days prior to vaccination
intention to travel out of the area prior to the study visit on Day 28 of the study
have a history of excessive alcohol consumption, drug abuse, significant psychiatric illness
have the intention to increase normal exercise routine, participate in contact sports or strenuous weight lifting or to initiate vigorous exercise from Screening until after Day 28 of the study