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New flu vaccine for seniors passes first safety check

NCT ID NCT07421050

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

80 people

The number who actually took part.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • 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.