FLUAD® vs. Fluzone® High-Dose Study
Condition: Pain; Quality of Life; Injection Site Reaction; Side Effect of Drug; Adverse Drug Event
MeSH terms: Injection Site Reaction; Drug-Related Side Effects and Adverse Reactions
Intervention: FLUAD®; Fluzone® High-Dose
Intervention description: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine; Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Subject, study coordinators, and investigators will be blinded to the type of flu vaccine administered. Only the vaccinator will be unblinded.
Enrollment: 757.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza vaccine; fever following vaccination; pain following vaccination; quality of life

Summary:

      The overall aim of the study is to compare safety and immunogenicity of inactivated influenza
      vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone®
      High-Dose) vaccine in persons ≥65 years (20% aged ≥80 years). A prospective, randomized,
      blinded clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza
      seasons. During each season, approximately 220 older adults will be enrolled at Duke
      University Medical Center and 140 older adults at Boston University Medical Center. Eligible
      subjects will be randomized to receive either adjuvanted influenza vaccine or High-Dose
      influenza vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and
      then return for a second blood draw without vaccination about 4 weeks later to assess for
      influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6
      months post-vaccination to assess for waning of influenza antibody titers. Subjects will
      record the occurrence of local and systemic reactions (including fever, pain, tenderness,
      swelling, redness, general systemic systems), unsolicited adverse events, medical care
      utilization, and changes in medications over 8 days following vaccination. In addition,
      serious adverse events and events of clinical interest will be assessed through 42 days
      post-vaccination. Health-related quality of life will be assessed pre-vaccination (Day 1) and
      on Days 3 and 9 post-vaccination.
    

Eligibility criteria:

        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

          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. 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

          3. 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.

          4. 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)

          5. Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating
             intramuscular injection

          6. History of febrile illness (> 100.0°F or 37.8°C) within the past 24 hours prior to IIV
             administration (temporary deferral)

          7. 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)

          8. Any history of Guillain-Barré syndrome

          9. Mild to severe dementia as determined by the Mini-Cog tool and the Rowland Universal
             Dementia Assessment Scale (RUDAS)

         10. Substance use that could interfere with study compliance

         11. 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)

         12. 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.

         13. Hearing loss determined by the investigators to prevent successful communication over
             the phone

         14. 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.

         15. Anyone who is a relative or subordinate of any research study personnel.