Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age

Exclusion Criteria

• •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• •Personal or family history of Guillain-Barré Syndrome (GBS).
• •Known systemic hypersensitivity to any of the study intervention components (Section 1.1, Section 6.1), or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances.
• •Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment.
• •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment.
• •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
• •Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• •Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
• •Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine prior to the second blood drawing (ie. approximately 4 weeks after the study intervention administration).
• •Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine.
• •Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
• •Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• •Deprived of freedom by an administrative or court order, or being in an emergency setting, or hospitalized involuntarily.
• •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 (ie.
• •parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.