Status and phase
Conditions
Treatments
About
This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written informed consent provided by the participant
Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
Willing to receive influenza vaccination
Older cohort has received their influenza vaccine for the previous influenza season
Exclusion criteria
Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily)
Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
Participant has received a community available influenza vaccine for the approaching influenza season
Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)
Primary purpose
Allocation
Interventional model
Masking
85 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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