Safety/Efficacy Study of Seqirus A/H7N9 IIV With or Without MF59(R) Adjuvant to Prevent Avian Influenza

Exclusion Criteria

• •1. Have an acute illness\*, as determined by the site Principal Investigatoor or appropriate sub-investigator, within 72 hours prior to study vaccination.
• •\*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• •2. Have any medical disease or condition that, in the opinion of the site Principal Investigator or appropriate sub-investigator, is a contraindication to study participation\*.
• •\*Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
• •3. Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
• •4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
• •5. Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
• •6. Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
• •7. Have known hypersensitivity or allergy to eggs, egg or chicken protein, neomycin, kanamycin, formaldehyde, polysorbate 80, cetyltrimethylammonium bromide (CTAB), squalene-based adjuvants, or other components of the study vaccine.
• •8. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
• •9. Have a history of Guillian-Barre Syndrome.
• •10. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
• •11. Have a history of Potentially Immune Mediated Medical Conditions (PIMMCs)
• •12. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
• •13. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
• •14. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
• •15. Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination.
• •16. Have taken high-dose inhaled corticosteroids\* within 30 days prior to each study vaccination.
• •\*High-dose defined as per age as using inhaled high dose per reference chart https://www.nhlbi.nih.gov/files/docs/guidelines/asthma\_qrg.pdf.
• •17. Received a licensed live vaccine within 30 days prior to the first study vaccination, or plan to receive a licensed live vaccine within 30 days before or after each study vaccination.
• •18. Received or plan to receive a licensed, inactivated, vaccine (excluding all flu vaccines) within 14 days before or after each study vaccination.
• •19. Received or plan to receive seasonal inactivated influenza virus (IIV) within 21 days before or after each study vaccination.
• •20. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to each study vaccination.
• •21. Received an experimental agent\* within 30 days prior to the first study vaccination, or expect to receive an experimental agent\*\* during the 13-month trial-reporting period.
• •\*Including vaccine, drug, biologic, device, blood product, or medication.
• •\*\*Other than from participation in this trial.
• •22. Are participating or plan to participate in another clinical trial with an interventional agent\* that will be received during the 13-month trial-reporting period.
• •\*Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.
• •23. Received or plan to receive an influenza A / H7 vaccine\* or have a history of influenza A / H7 subtype infection.
• •\*And assigned to a group receiving influenza A / H7 vaccine, does not apply to documented placebo recipients.
• •24. Have traveled to mainland China and had substantial\* direct contact with live or freshly slaughtered poultry or pigeons within the past five years.
• •\*Substantial contact is defined as visited a poultry farm and/or a live poultry market.
• •25. Occupational exposure to or substantial direct physical contact\* with birds in the past year and through the 21 days after the second study vaccination.
• •\*Exposure to free range chickens in the yard is exclusionary. Casual contact with birds at petting zoos or county or state fairs or having pet birds does not exclude subjects from study participation.
• •26. Female subjects who are breastfeeding at any given time from the first study vaccination until 30 days after the last study vaccination.
• •27. Plan to travel outside the US (continental US, Hawaii, and Alaska) from enrollment through 21 days after the second study vaccination.
• •28. Receipt of Multimeric-001 (M-001) vaccine.