H7N9 Mix and Match With MF59 in Healthy Elderly Persons

Exclusion Criteria

• •5. Oral temperature is less than 100.0 degrees F.
• •6. Pulse is 50 to 115 bpm, inclusive.
• •7. Systolic blood pressure is 85 to 160 mm Hg, inclusive.
• •8. Diastolic blood pressure is 55 to 95 mm Hg, inclusive
• •1\. Have an acute illness2, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination.
• •2An 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 participation3.
• •3Including acute or chronic medical disease or condition, defined as persisting 3 months (defined as 90 days) or longer, 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 study.
• •3\. Reside in a nursing home4 or other skilled nursing facility or have a requirement for skilled nursing care.
• •4An ambulatory subject who does not require skilled nursing care and is a resident of a retirement home or community is eligible for this clinical trial.
• •4\. Inability to provide informed consent or complete study activities, for example, due to dementia or other impairment.
• •5\. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
• •6\. Have known active neoplastic disease or a history of any hematologic malignancy.
• •7\. Have known HIV, hepatitis B, or hepatitis C infection. 8. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
• •9\. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
• •10\. Have a history of Guillain-Barré Syndrome. 11. Have a history of neuralgia, paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior to study vaccination.
• •12\. Have a history of autoimmune disease5. 5Including, but not limited to, autoimmune processes resulting in neuroinflammatory diseases, vasculitis, clotting disorders, dermatitis, arthritis, thyroiditis, or muscle, liver, or kidney disease.
• •13\. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
• •14\. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
• •15\. 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.
• •16\. Have taken oral or parenteral corticosteroids of any dose within 30 days prior to study vaccination.
• •17\. Have taken high-dose inhaled corticosteroidswithin 30 days prior to study vaccination. High-dose defined as \>800 mcg/day of beclomethasone dipropionate CFC or equivalent.
• •18\. Received a licensed live vaccine within 30 days prior to enrollment in this study, or plans to receive a licensed live vaccine within 30 days before or after each study vaccine.
• •19\. Received a licensed inactivated vaccine within 14 days prior to enrollment in this study, or plans to receive a licensed inactivated vaccine within 14 days before or after each study vaccine.
• •20\. Received immunoglobulin or other blood products within 90 days prior to study vaccination.
• •21\. Received an experimental agent6 within 30 days prior to the first study vaccination, or expects to receive an experimental agent7 during the 18-month study period.
• •6Including vaccine, drug, biologic, device, blood product, or medication. 7Other than from participation in this study. 22. Are participating or plan to participate in another clinical trial with an interventional agent8 during the 18-month study period.
• •8 Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.
• •23\. Prior participation in a clinical trial of influenza A/H7 vaccine9 or have a history of A/H7 actual or potential exposure or infection prior to the first study vaccination.
• •9And assigned to a group receiving influenza A/H7 vaccine, does not apply to documented placebo recipients.
• •24\. Plan to travel outside the US (continental US, Hawaii, and Alaska) within the 28 days following each study vaccination.