FLUAD® vs. Fluzone® High-Dose Study

Inclusion Criteria

• Persons aged ≥65 years, living in the community
• Intention of receiving IIV vaccine based on ACIP-CDC guidelines
• Willing to provide written informed consent prior to initiation of any study procedures
• Able to speak English
• Able and willing to complete baseline assessments and questionnaires, and to allow information to be collected from their electronic medical record
• Able and willing to complete post-vaccine assessments and questionnaires independently or with assistance
• Able and willing to have blood drawn for the study
• Able and willing to return in about one month for a follow-up visit including completing questionnaires and having another blood test
• Access to and ability to use a phone, independently or with assistance
• Adequate vision and motor skills to complete the diary form independently or with assistance.
• Not living in a skilled nursing facility/nursing home/long term acute care facility

Exclusion Criteria

• IIV receipt during the current influenza season prior to study enrollment
• Enrolled in this study during the 2017-18 (Year 1) influenza season

Note: Year 1 study participants will only be enrolled in Year 2 if they are participating in the sub-study on repeat vaccination

• Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 12 months.
• Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy*

*Participants with a history of malignancy may be included if, after previous treatment by surgical excision, chemotherapy or radiation therapy, the participant has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure (not less than 12 months)

• Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection
• History of febrile illness (> 100.0°F or 37.8°C) within the past 24 hours prior to IIV administration (temporary deferral)
• Contraindication to IIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component*, including egg protein; or a latex allergy

*Formaldehyde, Octylphenol ethoxylate, neomycin, kanamycin, barium, cetyltrimethlyammonium bromide (CTAB)

• Any history of Guillain-Barré syndrome
• Mild to severe dementia as determined by the Mini-Cog tool and the Rowland Universal Dementia Assessment Scale (RUDAS)
• Substance use that could interfere with study compliance
• Receipt of any inactivated licensed vaccine within 2 weeks, or live attenuated licensed vaccine within 4 weeks prior to enrollment in this study, or planning receipt of any vaccines during the 42-days post-vaccination period (including pneumococcal vaccines)
• Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product within 28 days of vaccine receipt. Co-enrollment in observational or behavioral intervention studies are allowed at any time while enrollment in a clinical trial involving an investigational product (other than vaccine) may occur after 30 days following vaccine receipt.
• Hearing loss determined by the investigators to prevent successful communication over the phone
• Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
• Anyone who is a relative or subordinate of any research study personnel.