Super-Sized flu shot shows promise for seniors
NCT ID NCT04537234
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a high-dose flu vaccine in 165 healthy adults aged 65 and older in Taiwan. Researchers compared the immune response and safety of the high-dose shot to a standard-dose flu vaccine. The goal was to see if the stronger dose could provide better protection against influenza in older adults, who are at higher risk for severe flu.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-Dose Quadrivalent Influenza Vaccine (Fluzone High Dose / Efluelda)
- What this could lead to
- If successful, this could show that a high-dose flu vaccine offers better protection for older adults, potentially reducing flu-related hospitalizations and complications.
- What could go wrong
- This is a completed phase 3 trial, but results may not apply to all populations. The study is relatively small (165 participants) and focused on immune response, not actual prevention of flu illness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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165 people
The number who actually took part.
- Started
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Nov 2020
- Finished
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Feb 2021
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria : * 65 years and older on the day of inclusion. * Able to attend all scheduled visits and complied with all study procedures. Exclusion criteria: * Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2. * Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances. * Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator's judgment contraindicate intramuscular vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. * Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to \[\>=\] 38.0 degree Celsius). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Personal or family history of Guillain-Barré syndrome. * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and had been disease free for \>=5 years). * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Investigational Site Number 1580001
Taipei, 100, Taiwan
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Investigational Site Number 1580002
Taipei, 112, Taiwan
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Investigational Site Number 1580003
Taoyuan, 333, Taiwan
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Investigational Site Number 1580004
Taichung, 40447, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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