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New High-Dose flu vaccine trial aims to better protect seniors

NCT ID NCT07302256

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

60 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 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Danjiangkou Disease Prevention and Control Center

    RECRUITING

    Wuhan, Hubei, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.