A Study to Evaluate the Safety of a Monovalent Vaccine in Healthy Adults

Exclusion Criteria

• •History of hypersensitivity of any component of the vaccine, including egg or egg protein
• •History of hypersensitivity to gentamicin
• •Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (e.g., asthma), chronic metabolic diseases (e.g., diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
• •Acute febrile (\>100.0°F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within the 14 days prior to randomization
• •Any known immunosuppressive condition or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy
• •History of Guillain-Barré syndrome
• •A household contact who is severely immunocompromised (e.g., hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); subject should additionally avoid close contact with severely immunocompromised individuals for at least 21 days after study vaccination
• •Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
• •Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination Note: A daily dose of up to 81 mg of aspirin for prophylactic use is not considered a contraindication to enrollment.
• •Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
• •Nursing mother
• •Employee of the research center, any individual involved with the conduct of the study, or any family member of such individuals
• •Any condition (e.g., chronic cough, allergic rhinitis) that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results