FLUADĀ® vs. FluzoneĀ® High-Dose Study (NCT03183908) | Clinical Trial Compass
CompletedPhase 4
FLUADĀ® vs. FluzoneĀ® High-Dose Study
United States757 participantsStarted 2017-08-28
Plain-language summary
The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUADĀ®) versus High-Dose inactivated influenza (FluzoneĀ® High-Dose) vaccine in persons ā„65 years (20% aged ā„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.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
ā. Persons aged ā„65 years, living in the community
ā. Intention of receiving IIV vaccine based on ACIP-CDC guidelines
ā. Willing to provide written informed consent prior to initiation of any study procedures
ā. Able to speak English
ā. Able and willing to complete baseline assessments and questionnaires, and to allow information to be collected from their electronic medical record
ā. Able and willing to complete post-vaccine assessments and questionnaires independently or with assistance
ā. Able and willing to have blood drawn for the study
ā. Able and willing to return in about one month for a follow-up visit including completing questionnaires and having another blood test
Exclusion criteria
ā. IIV receipt during the current influenza season prior to study enrollment
What they're measuring
1
Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1
Timeframe: Days 1 through 8 post-vaccination
2
Number of Participants With Adverse Events of Clinical Interest, Population 2
Timeframe: 42 days post-vaccination and compared between the two groups.
3
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Timeframe: 42 days post-vaccination and compared between the two groups.
4
Number of Participants With H3N2 HAI Seroconversion
. Enrolled in this study during the 2017-18 (Year 1) influenza season
ā. 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.
ā. 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\*
ā. Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection
ā. History of febrile illness (\> 100.0Ā°F or 37.8Ā°C) within the past 24 hours prior to IIV administration (temporary deferral)
ā. 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