Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants 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
• •Household contact who is immunocompromised (participant should also avoid close contact with immunocompromised individuals for at least 21 days post study vaccination)
• •Receipt of any investigational agent within 30 days prior to enrollment, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
• •Chronic or regular use of anti-pyretic or analgesic medication on a daily or every other day basis.
• •Note: A daily dose of 81 mg of aspirin is not considered a contraindication to enrollment. Discontinuation of prophylactic use of anti-pyretic or analgesic medications at the time of enrollment and for 14 days following vaccination 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 that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of study results