A Phase 4 interventional study of Flu Vaccine in Elderly Immune System, sponsored by Health Sciences North Research Institute. Completed at 2 sites in 2 countries. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Health Sciences North Research Institute · Phase 4, Interventional, and Prevention
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
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 393 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Health Sciences North Research Institute is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Older cohort has received their influenza vaccine for the previous influenza season
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Exclusion Criteria:
Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)
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Fluzone Standard Dose Influenza Vaccine
Biological: Flu Vaccine
Fluzone High Dose Influenza Vaccine
Biological: Flu Vaccine
Also known as: Fluzone HD
Number of Influenza Cases
Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (\> 99°F or 37.3°C orally or 100°F rectally) \[41\]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season.
Time frame: five years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Health Sciences North Research Institute