A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine

Exclusion Criteria

• •History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life-threatening, or severe reactions to previous influenza vaccinations
• •History of hypersensitivity to gentamicin
• •Any condition for which the inactivated influenza vaccine was indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, 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 (eg, cough or sore throat) within 14 days prior to randomization
• •Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus \[HIV\] infection, or ongoing immunosuppressive therapy
• •History of Guillain-Barré syndrome
• •A household contact who was severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual required care in a protective environment); subject should additionally have avoided close contact with severely immunocompromised individuals for at least 21 days after receipt of investigational product
• •Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the package insert was permitted)
• •Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of investigational product
• •Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of investigational product
• •Known or suspected mitochondrial encephalomyopathy
• •Nursing mother
• •Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would have interfered with evaluation of the investigational product or interpretation of subject safety or study results
• •Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals