New flu vaccine for seniors passes first safety check
NCT ID NCT07421050
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether a new flu vaccine with an adjuvant (a booster ingredient) is safe for adults aged 65 and older. Eighty volunteers will receive a single shot and be monitored for side effects over a year. The study does not yet test if the vaccine prevents flu, only its safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Subunit Influenza Vaccine (Adjuvant)
- What this could lead to
- If this vaccine is found safe, it could lead to a better flu shot 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 80 people, so it can't prove the vaccine works. It only checks for immediate safety issues.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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80 people
The number who actually took part.
- Started
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Nov 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Age at enrollment is ≥65 years (including the 65th birthday). * The participant voluntarily agrees to take part in the trial and has signed the informed consent form. * The participant is able to comply with the trial follow-up schedule as required by the protocol (i.e., no plans for long-term absence or relocation from the study site). * Medically stable: The participant may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but symptoms/signs must be controlled. If the participant is on any medication, the dosage must have remained stable for at least three weeks prior to vaccination. Exclusion Criteria: * Axillary temperature \>37.0°C. * Confirmed influenza virus infection by laboratory test or self-test kit positive within the past 12 months. * Received any influenza vaccine (licensed or investigational) within the past 12 months or plans to receive any influenza vaccine during the study. * Known or suspected allergic to any component of the investigational vaccine. * A history of severe allergic reactions to any vaccines or medications (for example, but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction)). * Congenital malformations or developmental disorders, and genetic defects or severe malnutrition. * History of convulsions or seizures, epilepsy, psychiatric disorders, or relevant family history. * Severe liver and kidney diseases, malignant tumors, various acute diseases, or being in the acute exacerbation stage of a chronic disease. * Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other immune-mediated/autoimmune diseases. * A history of asthma, unstable within the past two years requiring emergency treatment, hospitalization, intubation, or oral/intravenous corticosteroids. * Individuals who have received immunostimulant or immunosuppressant therapy within the past 6 months (continuously administered orally or via drip infusion for more than 14 days). * Suffering from severe cardiovascular diseases (e.g., heart disease, cor pulmonale, pulmonary edema). * Blood pressure ≥150/100 mmHg despite medication control. * History of live attenuated vaccine within 28 days prior to vaccination, or any other vaccine within 14 days prior to vaccination. * Diagnosed with progressive neurological diseases, or a history of Guillain-Barré syndrome. * Asplenia or functional asplenia, including splenectomy due to any reason, or resection/partial removal of other vital organs. * Received blood or blood-derived products within the past 6 months. * A diagnosed history of coagulation disorders (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders). * Currently undergoing anti-tuberculosis treatment. * Clinically significant abnormalities in laboratory tests (blood biochemistry, blood routine and urine routine) as determined by the investigator. * Any condition that, in the opinion of the investigator, makes the participant unsuitable for this 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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Gucheng County Center for Disease Control and Prevention
Xiangyang, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- When the immune system Can't fight back: tracking three respiratory viruses
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- 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?