Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older

Exclusion Criteria

• •1. Persons who previously received an H5N1 or H7N9 influenza vaccine or who plan to receive an H5N1or H7N9 influenza vaccine while participating in the study.
• •2. Persons who plan to receive a seasonal influenza vaccine earlier than Day 42 of participation in this study, i.e. before the post-vaccination serology sample is obtained.
• •3. Persons with an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of immune responses.
• •4. Persons taking medications or treatments that may adversely affect the immune system, e.g. cytotoxic agents, immunosuppressive doses of corticosteroids, anti-TNFα agents.
• •5. Persons with an active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
• •6. Persons with a history of documented autoimmune disease.
• •7. Women currently pregnant, nursing mothers or women planning a pregnancy between enrollment and 42 days after randomization.
• •8. Persons who have had a prior serious reaction to any influenza vaccine.
• •9. Persons with a known history of Guillain-Barré Syndrome (GBS).
• •10. Persons with a history of anaphylactic-type reaction to injected vaccines.
• •11. Persons with a history of illicit drug use or alcohol abuse that may compromise the subject's ability to comply with the protocol.
• •12. Persons who received a seasonal influenza vaccine \< 6 months prior to enrollment (may delay enrollment).
• •14. Persons who have had an acute illness or fever (\>38º C or \>100º F) within three days prior to study enrollment (enrollment may be delayed for full recovery, if acceptable to investigator).
• •15. Persons currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication) or have received an experimental agent within 1 month prior to enrollment in this study, or who expect to receive another experimental agent during participation, or intend to donate blood during the 42-day primary study period.
• •16. Persons who received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. Persons who expect to receive immunoglobulin or another blood product during the 42-day primary period of this study.