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One shot for two threats: can a single vaccine stop flu and COVID?

NCT ID NCT07790523

Prevention Sponsor: Tor Biering-Sørensen 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether a single combined mRNA vaccine, mCombriax (mRNA-1083), can protect adults aged 65 and older against both influenza and COVID-19 as effectively as getting two separate shots on the same day. Researchers will compare how many participants in each group develop medically attended flu or COVID-19, or end up hospitalized for these infections. The study enrolls a large number of older adults, a group at higher risk for severe illness from both viruses.

What this could mean

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

Active substance
mCombriax (mRNA-1083), a combined mRNA vaccine targeting both influenza and SARS-CoV-2
What this could lead to
If it works, a single annual shot could replace two separate vaccines for older adults, simplifying protection against flu and COVID-19.
What could go wrong
The trial is large but pragmatic, so results may vary with real-world conditions. The combined vaccine might not match the effectiveness of separate shots, and side effects could differ.

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

About 410,000 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

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: 1. Age ≥65 years at the time of vaccination 2. Self-reported ability to understand written and spoken English or Danish (Denmark only) or Spanish or Galician (Spain only) 3. Informed consent form has been signed and dated Exclusion Criteria: * There are no specific exclusion criteria for this study

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Conditions

The condition(s) this trial relates to.

respiratory system disorder COVID-19 prevention target influenza prevention target

As listed by the trial registrant

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

COVID-19 Influenza

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. 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

  • Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

    Hellerup, 2900, Denmark

  • Danske Lægers Vaccinations Service

    Søborg, 2860, Denmark

  • General Public Health Directorate of Galician Health Service

    Santiago de Compostela, A Coruña, Spain

More trials for these conditions

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