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One shot for two viruses? new combo vaccine enters early human testing

NCT ID NCT07464314

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This early-stage study is testing a new mRNA vaccine that aims to protect against both seasonal flu and COVID-19 with a single shot. Around 1,475 healthy adults aged 65 to 85 will receive either the new combo vaccine, a standard flu vaccine, or a licensed COVID-19 vaccine. Researchers will closely monitor side effects and measure immune responses through blood samples to see how well the body builds defenses against 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
mRNA seasonal flu/COVID-19 combination vaccine
What this could lead to
If successful, this could lead to a single annual shot that protects against both flu and COVID-19, simplifying vaccination.
What could go wrong
This is a very early (Phase 1) study focused on safety and immune response, not yet on preventing illness. The vaccine may not work as hoped or could cause 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 225 people

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

Started

Mar 2026

Expected to finish

Jun 2027

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

65 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of the caregiver. 2. Informed consent obtained from the participant prior to performance of any study-specific procedure. 3. A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening. 4. Healthy participants or medically stable patients as established by medical history and clinical examination. 5. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: 1. Any clinically significant laboratory abnormality. 2. History of symptomatic influenza/ SARS-CoV-2 infection confirmed by local health authority-approved testing methods within 180 days (for influenza) or 90 days (SARS-CoV-2 infection) prior to study intervention administration. 3. History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine. 4. Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for \>5 years. 5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 6. History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection. 7. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). 8. Acute or unstable chronic conditions, clinically significant pulmonary, cardiovascular, or renal functional abnormality, as determined by physical examination and/or laboratory screening tests. 9. History of hypersensitivity or allergic reaction to any previous influenza or COVID-19 vaccine. 10. History of hypersensitivity or allergic reaction to any previous mRNA vaccine. 11. Administration of any influenza vaccine within 181 days before the study intervention administration (Day -180 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration. 12. Administration of a SARS-CoV-2 antigen-containing vaccine in the period starting 91 days before the study intervention administration (Day -90 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration. 13. Administration of any mRNA-based vaccine in the period starting 29 days before the study intervention administration (Day -28 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration. 14. Administration of any other vaccine not foreseen by the study protocol in the period starting 29 days (Day -28 to Day 1) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration. 15. Other protocol-defined exclusion criteria may apply.

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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

    12 sites. 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

  • GSK Investigational Site

    RECRUITING

    Anniston, Alabama, 36207, United States

  • GSK Investigational Site

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • GSK Investigational Site

    RECRUITING

    Fair Oaks, California, 95628, United States

  • GSK Investigational Site

    RECRUITING

    San Diego, California, 92123, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33186, United States

  • GSK Investigational Site

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • GSK Investigational Site

    RECRUITING

    West Palm Beach, Florida, 33409, United States

  • GSK Investigational Site

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • GSK Investigational Site

    RECRUITING

    Austin, Texas, 78705, United States

  • GSK Investigational Site

    RECRUITING

    Charlottesville, Virginia, 22911, United States

  • GSK Investigational Site

    RECRUITING

    Newport News, Virginia, 23606, United States

  • GSK Investigational Site

    RECRUITING

    Seattle, Washington, 98104, United States