Can a stronger flu shot better protect seniors?
NCT ID NCT07737106
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial is testing whether a high-dose flu vaccine is safe and triggers a stronger immune response in adults aged 60 and older compared to the standard-dose vaccine. Participants receive a single injection and are monitored for side effects and antibody levels. The goal is to see if a higher dose can offer better protection against influenza in this age group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a high-dose influenza vaccine (split virion, inactivated) containing 60 µg of hemagglutinin per strain
- What this could lead to
- If successful, this high-dose flu vaccine could offer better protection against influenza for older adults, who are at higher risk of severe illness.
- What could go wrong
- This is an early-phase trial with only 50 participants, so results may not apply to the general population. Higher doses can also increase the chance of side effects like injection-site reactions.
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
-
50 people
The number who actually took part.
- Started
-
Aug 2025
- Finished
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Feb 2026
- 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
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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: 1. Participants aged 60 years and older who are in stable health condition. 2. Participants who are fully informed and voluntarily sign the informed consent form. 3. Participants who are willing and able to comply with all study procedures and remain contactable throughout the study. 4. Participants who are able to provide valid legal identification. Exclusion Criteria: 1. Participants who have received a seasonal influenza vaccine within 6 months before enrollment, have received a seasonal influenza vaccine for the current influenza season, or plan to receive a seasonal influenza vaccine during the study. 2. Participants who have had seasonal influenza within 6 months before enrollment. 3. Participants with known severe allergy to any vaccine or vaccine component, such as urticaria, dyspnea, angioedema, or anaphylactic shock. 4. Participants with poorly controlled chronic diseases or a history of serious diseases, including but not limited to cardiovascular diseases, such as hypertension not controlled by medication (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg measured at the study site) or coronary heart disease; metabolic diseases, such as poorly controlled diabetes; hematologic diseases; hepatic or renal diseases; digestive system diseases; respiratory system diseases; malignant tumors; a history of major organ transplantation; or any other disease or physiological condition that, in the investigator's opinion, may interfere with the study results. 5. Participants with autoimmune diseases or immunodeficiency diseases, including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, or HIV infection. 6. Participants with coagulation disorders, such as coagulation factor deficiency or platelet abnormalities. 7. Participants with current or previous severe neurological disease or psychiatric disease, or a family history of psychiatric disease. 8. Participants with a history of long-term alcohol abuse or drug abuse. 9. Participants with a history of Guillain-Barré syndrome (GBS). 10. Participants who have received immunosuppressive agents or other immunomodulatory therapy for ≥14 days within the past 6 months (prednisone ≥20 mg/day or equivalent), cytotoxic therapy, or plan to receive such therapy during the study. Corticosteroid spray therapy for allergic rhinitis and topical corticosteroid therapy for acute uncomplicated dermatitis are excluded from this criterion. 11. Participants who have received immunoglobulin or other blood products within 3 months before receiving the study vaccine, or plan to receive such treatment during the study. 12. Participants who have received other investigational drugs or vaccines within 30 days before receiving the study vaccine, or plan to receive such drugs or vaccines during the study. 13. Participants who have received live attenuated vaccines or RNA vaccines within 14 days before receiving the study vaccine. 14. Participants who have received subunit or inactivated vaccines within 7 days before receiving the study vaccine. 15. Participants with any acute disease, acute exacerbation of a chronic disease, or known or suspected active infection within the past 7 days. 16. Participants with fever on the planned day of study vaccination, defined as axillary temperature \>37.0°C before vaccination. 17. Participants who, in the investigator's opinion, have any other factors that make them unsuitable for participation in the 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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Urad Middle Banner Center for Disease Control and Prevention
Bayan Nur, Inner Mongolia, 015300, 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 new pill shorten the flu?