FLUAD vs. Fluzone High-Dose Study

Inclusion Criteria:

1. Persons aged ≥65 years, living in the community

2. Intention of receiving IIV vaccine based on ACIP-CDC guidelines

3. Willing to provide written informed consent prior to initiation of any study
procedures

4. Able to speak English at the Duke site and English or Spanish at the Boston site

5. Able and willing to complete baseline assessments and questionnaires, and to allow
information to be collected from their electronic medical record

6. Able and willing to complete post-vaccine assessments and questionnaires independently
or with assistance

7. Able and willing to have blood drawn for the study

8. Able and willing to return in about one month for a follow-up visit including
completing questionnaires and having another blood test

9. Access to and ability to use a phone, independently or with assistance

10. Adequate vision and motor skills to complete the diary form independently or with
assistance.

11. Not living in a skilled nursing facility/nursing home/long term acute care facility

Exclusion Criteria:

1. IIV receipt during the current influenza season prior to study enrollment

2. 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.

3. 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)

4. Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating
intramuscular injection (a daily aspirin may be acceptable).

5. History of febrile illness (> 100.0°F or 37.8°C) within the past 24 hours prior to IIV
administration (temporary deferral)

6. 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

7. Any history of Guillain-Barré syndrome

8. Mild to severe dementia as determined by the Mini-Cog tool and the Rowland Universal
Dementia Assessment Scale (RUDAS)

9. Substance use that could interfere with study compliance

10. 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 28-day post-vaccination period (including pneumococcal
vaccines)

11. 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.

12. Hearing loss determined by the investigators to prevent successful communication over
the phone

13. 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.

14. Anyone who is a relative or subordinate of any research study personnel.