Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine

Exclusion Criteria

• •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease. More information on this criterion can be found in the protocol.
• •Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, intereferes with the study
• •Previous receipt of FluMist or any intranasal live attenuated influenza vaccine
• •Previous enrollment in an H6N1 influenza vaccine trial or in any study of an avian influenza vaccine
• •Seropositive to the H6N1 influenza A virus (serum HAI titer \>1:8)
• •Positive urine drug toxicology test indicating narcotic use and/or dependency as defined by the Drug Enforcement Agency
• •Medical, occupational, or family problems as a result of alcohol or illicit drug use within the 12 months prior to study entry
• •Any condition that, in the opinion of the investigator, would interfere with the study
• •History of anaphylaxis
• •Allergy to oseltamivir as determined by subject report
• •Current diagnosis of asthma or reactive airway disease within 2 years prior to study entry
• •History of Guillain-Barre Syndrome
• •HIV-1-infected
• •Hepatitis C-infected
• •Positive hepatitis B virus surface antigen
• •Known immunodeficiency syndrome
• •Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to study entry
• •Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study entry
• •History of a surgical splenectomy
• •Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study entry
• •Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the protocol.
• •Travel to the Southern Hemisphere within 14 days prior to study entry
• •Travel on a cruise ship within 14 days prior to study entry
• •Direct contact with live poultry within the 14 days prior to the study or after study completion.
• •Receipt of another investigational vaccine or drug within 30 days prior to study entry
• •Allergy to eggs or egg products
• •Pregnant or breastfeeding