A Safety and Immunogenicity Study of IVACFLU-A/H5N1

Inclusion Criteria

• Male or female adult 18 through 60 years of age at the enrollment visit.
• Literate (by self-report) and willing to provide written informed consent.
• Healthy adults, as established by the medical history and screening evaluations, including physical examination, capable and willing to complete Diary Cards, and willing to return for all follow-up visits.
• For females able to become pregnant, willing to utilize reliable birth control measures (intrauterine device, hormonal contraception, condoms) through the Day 43 visit.

Exclusion Criteria

• Participation in another clinical trial involving any vaccine or therapy within the previous three months, or planned enrollment in such a trial during the period of this study.
• Received any non-study vaccine within 4 weeks prior to enrollment or refused to postpone receipt of such vaccines until after the Day 43 visit.
• Current or recent (within 2 weeks of enrollment) acute illness with or without fever.
• Received immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 43 visit.
• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this meant prednisone or equivalent, 0.5 mg per kg per day; topical or intranasal steroids were allowed.)
• History of asthma.
• Hypersensitivity after previous administration of any vaccine.
• Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein, antibiotics, and rubber (from the vaccine vial stoppers).
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric, or renal functional abnormality, as determined by medical history, physical examination, or clinical laboratory screening tests (Phase 2 only), which in the opinion of the investigator, might have interfered with the study objectives.
• History of any blood or solid organ cancer.
• History of thrombocytopenic purpura or known bleeding disorder.
• History of seizures.
• Known or suspected immunosuppressed or immune deficient condition of any kind.
• Known Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection by self-report (Phase 3) or a positive test for either HBV surface antigen (HBsAg) or HCV antibody using anti-HCV test (Phase 2).
• Known HIV infection (self-report)
• Known active tuberculosis or symptoms of active tuberculosis (self-report).
• History of chronic alcohol abuse and/or illegal drug use.
• Pregnancy or lactation (a negative pregnancy test was required before administration of study product for all women of childbearing potential).
• History of Guillain-Barre Syndrome.
• Any condition in the opinion of the investigator that would have increased the health risk of the subject if he/she participated in the study or interfered with the evaluation of the study objectives.

Note: Minor out-of-range laboratory values no greater than Grade 1 were not considered to be exclusionary at screening.