A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant

Exclusion Criteria

• •Subjects will be excluded if they meet any of the following criteria:
• •1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
• •* Asymptomatic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the Investigator.
• •* Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
• •2. Any grade 1 or higher (as based on the Toxicity Grading Scale \[TGS\]) abnormality in ALT, AST, alkaline phosphatase, total bilirubin, blood urea nitrogen, or creatinine levels.
• •3. Any grade 2 or higher (as based on the TGS) vital sign or clinical laboratory abnormality not specified in criterion 2 above. Note that any abnormal vital sign may be repeated at the Investigator's discretion.
• •4. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
• •5. History of a serious reaction to prior influenza vaccination.
• •6. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
• •7. Received any vaccine in the 4 weeks preceding the study vaccination; or any A(H7N9) avian influenza vaccine at any time.
• •8. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
• •9. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
• •10. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
• •11. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \>38.0°C on the planned day of vaccine administration).
• •12. Known disturbance of coagulation.
• •13. Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
• •14. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.