Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults

Exclusion Criteria

• •1. Individuals not able to understand and follow study procedures,
• •2. History of any significant illness,
• •3. History of any chronic medical condition or progressive disease,
• •4. Presence of medically significant cancer,
• •5. Known or suspected impairment/alteration of immune function,
• •6. Presence of any progressive or severe neurologic disorder,
• •7. Presence of any bleeding disorders or conditions that prolongs bleeding time,
• •8. History of allergy to vaccine components,
• •9. Receipt of any other investigational product within 30 days prior to entry into the study,
• •10. History of previous H5N1 vaccination,
• •11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
• •12. Receipt of any other vaccine within 2 weeks prior to entry into the study
• •13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
• •14. Pregnant or breast feeding,
• •15. Females of childbearing potential refusing to use acceptable method of birth control,
• •16. Body mass index (BMI) ≥ 35 kg/m2,
• •17. History of drug or alcohol abuse,
• •18. Any planned surgery during study period,
• •19. Individuals conducting the study and their immediate family members,
• •20. Individuals with behavioral or cognitive impairment or psychiatric diseases.