Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal VLP Quadrivalent Influenza Vaccine in the Elderly Population

Exclusion Criteria

• •1. According to Investigator's opinion, presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. "Uncontrolled" is defined as:
• •1. Requiring a new medical or surgical treatment within one month prior to study vaccine administration which would interfere with vaccine evaluation or study completion (subject requiring medical or surgical treatment that would not interfere with evaluation \[e.g., minor knee surgery, cataracts, etc.\] would be eligible);
• •2. Requiring a change in medication dosage in one month prior to study vaccine administration due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable).
• •2. Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigator's opinion, would render the subject unable to provide informed consent or unable to provide valid safety observations and reporting.
• •3. Any autoimmune disease or any confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection, Hepatitis B or C, or the presence of lymphoproliferative disease.
• •4. Administration of any vaccine (including any other influenza vaccine) within 30 days prior to study enrolment or planned administration within the period from the vaccination up to blood sampling at Day 21 or within 30 days prior to blood sampling at Day 201. Immunization on an emergency basis will be evaluated in a case-by-case by the Investigator.
• •5. Administration of any adjuvanted or investigational influenza vaccine within 1 year prior to study enrolment or planned administration prior to the end of this trial (Day 201). Administration of any 'standard', not adjuvanted influenza vaccine (e.g., live attenuated Trivalent Inactivated Influenza Vaccine (TIV) or Quadrivalent Inactivated Vaccine (QIV) vaccine IN or split TIV or QIV vaccine by either intra-dermal or intramuscular route) prior to the 30-day exclusion period mentioned above would be acceptable.
• •6. Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period. Subjects may not participate in any other investigational or marketed drug study while participating in this study (approximately 7-12 months \[depending when subjects undergo screening session and Day 201 visit\]).
• •7. Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone per day, or equivalent for more than 7 consecutive days or for 10 or more days in total, within one month of study vaccine administration, any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within 3 months of vaccination. Routine use of standard doses of nasal or inhaled glucocorticoids is allowed.
• •8. Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin (no more than 325 mg/day), and without a clinically apparent bleeding tendency are eligible. Subjects treated with new generation drugs that will not increase risk of intramuscular bleeding (such as clopidogrel) are also eligible.
• •9. History of allergy to any of the constituents of the VLP quadrivalent study vaccine, Alhydrogel® (aluminum hydroxide) or to the phosphate buffered saline (PBS; used as placebo), or tobacco allergy.
• •10. History of anaphylaxis reaction to any food, medication or bee sting.
• •11. Any history of severe asthma (e.g., status asthmatic, hospitalization for asthma control) or recurrent asthma episodes requiring medical attention in the last 3 years (≥ 1 episode/year).
• •12. Continuous use of anti-histamines in the last 4 weeks prior to immunization or use of anti-histamines 48 hours prior to study immunization.
• •13. Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at injection site which may interfere with injection site reaction rating.
• •14. Have received a blood transfusion within 90 days prior to study vaccination.
• •15. If female, have a positive or doubtful pregnancy test prior to immunization or lactating females.
• •16. Vital sign abnormalities (systolic blood pressure and/or diastolic blood pressure, heart rate). Although a vital signs measurement is out of the acceptable ranges, a subject may be included in the study based on Investigator's judgment. Presence of any febrile illness (including oral temperature (OT) ≥38.0˚C within 24 hours prior to immunization). Such subjects may be re-evaluated for enrolment after resolution of illness.
• •17. Cancer or treatment for cancer within 3 years of study vaccine administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible. Person with non-treated, non-disseminated local prostate cancer are eligible.
• •18. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.