FLUAD vs. Fluzone High-Dose Study



Status:Recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:65 - Any
Updated:9/29/2018
Start Date:August 28, 2017
End Date:September 2019
Contact:Kenneth Schmader, MD
Email:kenneth.schmader@duke.edu
Phone:919-660-7500

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Safety and Immunogenicity of Adjuvanted Versus High-Dose Inactivated Influenza Vaccines in Older Adults

The overall aim of the study is to compare safety and immunogenicity of adjuvanted
inactivated influenza vaccine (IIV) (FLUAD) versus High-Dose inactivated influenza (Fluzone
High Dose) vaccine in ≥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. Quality of life will be assessed 8 days post-vaccination and vaccine
perceptions surveys will be administered 8 days and 4 weeks post-vaccination.


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.
We found this trial at
4
sites
Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Kenneth Schmader, MD
Phone: 919-660-7500
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Elizabeth Schlaudecker, MD, MPH
Phone: 513-803-5183
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Boston, Massachusetts 02118
Principal Investigator: Elizabeth Barnett, MD
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Boston, MA
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