New High-Dose flu vaccine trial aims to better protect seniors
NCT ID NCT07302256
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new influenza vaccine in 120 adults aged 60 and older. Participants receive either a high-dose vaccine, a standard-dose vaccine, or a placebo. The study focuses on safety and how well the vaccine triggers an immune response, with the goal of developing a more effective flu shot for older adults.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Influenza virus split vaccine (high-dose and standard-dose)
- What this could lead to
- If successful, this could lead to a more effective flu vaccine for older adults, who are at higher risk of severe flu.
- What could go wrong
- This is a very early Phase 1 trial with only 120 people, so it is primarily checking safety and immune response, not yet proving the vaccine prevents flu. The higher dose may cause more side effects.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- 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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60 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: * Age over 60 years old, gender not limited, and able to provide legal identification; * Volunteers voluntarily participate in the study and sign an informed consent form; * Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits. Exclusion Criteria: * On the day of enrollment, the axillary temperature was ≥ 37.3 ℃; * Those who have had influenza in the past 6 months or meet the definition of influenza like cases; * Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period; * Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine/drug, or history of asthma; * Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or an acute exacerbation of a chronic disease; * Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination; * Have received any vaccine within 2 weeks prior to vaccination; * Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to receiving the experimental vaccine, For example, immunosuppressive doses of glucocorticoids, monoclonal antibodies, thymosin, interferon, etc., or planned to receive such treatment within one month after the first dose of vaccination to full immunization, but local medication is allowed; * Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, or other autoimmune diseases; * Suffering from serious chronic diseases, serious cardiovascular diseases, such as hypertension that cannot be controlled by drugs, diabetes that cannot be controlled by drugs or has serious complications, liver and kidney diseases, pulmonary edema, malignant tumors, etc; * Have received blood or blood related products within the past 6 months; * Individuals with progressive neurological disorders, including a history of seizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or family history; * Have a history of abnormal coagulation function and have been using anticoagulants within 3 weeks before vaccination; * Patients with splenectomy, functional splenectomy, splenectomy, or other important organ resection or partial resection; * Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit; * Currently or recently planning to participate in other clinical trials; * Abnormal laboratory test indicators before vaccination; * Researchers determine any situation that is not suitable for clinical trials.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Danjiangkou Disease Prevention and Control Center
RECRUITINGWuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Flu shot showdown: can anflu match vaxigrip in Moms-to-Be?
- When the immune system Can't fight back: tracking three respiratory viruses
- Flu's journey: scientists track how influenza passes between people
- Can a stronger flu shot boost immunity in older adults?
- A nudge in the mailbox: could a letter boost flu shots for millions at risk?
- Can a new pill shorten the flu?