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Can a stronger flu shot boost immunity in older adults?

NCT ID NCT07805837

Prevention Sponsor: Korea University Guro Hospital Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests three flu vaccines in adults aged 65 and older: a standard dose, one with an adjuvant to boost response, and a high-dose version. Researchers measure antibody levels and immune cell activity to see which vaccine triggers the strongest protection. They also examine gut bacteria to learn whether the microbiome influences how well the vaccine works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Three influenza vaccine formulations: standard-dose, MF59-adjuvanted, and high-dose, given as a single injection
What this could lead to
If it works, this could identify which flu vaccine best protects older adults and explain how gut bacteria influence vaccine response.
What could go wrong
The trial is small and open-label, so results may not apply to everyone. Immune responses vary widely in older adults, and the gut microbiome's role is still uncertain.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

121 people

The number who actually took part.

Started

Oct 2025

Finished

Aug 2026

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 ≥65 years * Able and willing to provide informed consent Exclusion Criteria: * Influenza vaccination within the past 6 months * Laboratory-confirmed influenza infection within the past 6 months * Immunocompromised status * Uncontrolled chronic medical conditions

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune response Influenza Influenza vaccines Microbiome

Contacts and locations

Locations

  • Korea University Guro Hospital

    Seoul, Seoul, 08308, South Korea

More trials for these conditions

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