Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

Exclusion Criteria

• •Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
• •Participation at the time of study enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• •Receipt of any vaccine in the 30 days preceding the first trial vaccination, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
• •Previous vaccination against influenza (in the 2016-2017 influenza season) with either the trial vaccine or another vaccine.
• •Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
• •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).
• •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
• •Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
• •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
• •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• •Current alcohol abuse or drug addiction.
• •Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
• •Moderate or severe acute illness/infection (according to Investigator judgment) on the day of planned vaccination or febrile illness (temperature ≥100.4°F \[38.0°C\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• •Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study (participants ≥18 years of age) 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 (all participants).
• •History of serious adverse reaction to any influenza vaccine.
• •Personal history of Guillain-Barré syndrome.
• •Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
• •Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
• •Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.