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Can mRNA technology outsmart the flu in older adults?

NCT ID NCT07805707

Vaccine Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

This large phase 3 trial compares an investigational mRNA flu vaccine with a licensed flu vaccine in adults aged 65 and older. Each participant receives a single injection and is followed through the flu season. Researchers measure how well the mRNA vaccine prevents laboratory-confirmed flu illness, as well as its side effects and immune response. The goal is to see if the mRNA approach offers better protection for 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
an investigational mRNA seasonal flu vaccine
What this could lead to
If it works, this could offer older adults stronger protection against seasonal flu than current vaccines.
What could go wrong
The vaccine is still experimental, and even if it performs well in this trial, it may not prove better than existing options or may cause unexpected 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 54,000 people

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

Started

Sep 2026

Expected to finish

Jun 2028

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 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. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of a caregiver. 2. Written or witnessed (physically or digitally) informed consent obtained from the participant/Legally acceptable representative \[LAR(s)\] of the participant prior to performance of any study-specific procedure. 3. Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. 4. A male or female participant at least 65 YOA at the time of the study intervention administration. Exclusion Criteria: 1. History of test-confirmed influenza infection within 180 days prior to study intervention administration. 2. Any confirmed or suspected immunosuppressive or immunodeficient condition. HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, their CD4 cell count is ≥ 200/mm³ and their viral load has been undetectable. 3. Hypersensitivity to latex. 4. History of myocarditis or pericarditis considered causally associated with mRNA vaccine. 5. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). 6. History of hypersensitivity or allergic reaction to any previous influenza vaccine. 7. History of hypersensitivity or allergic reaction to any previous mRNA vaccine. 8. History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine. 9. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study 10. Acute or unstable chronic conditions \[clinically significant pulmonary, cardiovascular, hepatic, metabolic/endocrine disorders, renal functional abnormality, or psychiatric conditions\], as determined by medical history and clinical examination. 11. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant, due to participation in the clinical study. 12. Condition that in the judgment of the investigator would make intramuscular injection unsafe. 13. Administration of an influenza vaccine in the period starting 180 days before the study intervention administration or planned administration at any time during the study. 14. Planned administration/administration of any mRNA-based vaccine, live vaccine or adjuvanted protein-based vaccine in the period starting 30 days before the study intervention administration (Day -29 to Day 1) and ending 28 days after the study intervention administration (Day 1 to Day 28) or a non-replicating vaccine in the period starting 15 days before the study intervention administration (Day -14 to Day 1) and ending 14 days after the study intervention administration (Day 1 to Day 14). 15. Use of any investigational or non-registered product (drug, vaccine or invasive medical device in the country of enrollment) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or their planned use during the study period. 16. Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention (Day -89 to Day 1) or planned administration during the study period. 17. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. * Up to 90 days prior to the study intervention administration: * For systemic corticosteroids: prednisone equivalent ≥20 mg/day for \>14 days. Inhaled, intra articular/intra-bursal, and topical steroids are allowed. * Long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. 18. Administration of antitumoral medication during the period starting 90 days before the study intervention (Day -89 to Day 1) or planned administration during the study period. 19. Administration of any vaccine in a clinical trial investigating an influenza mRNA vaccine in the period starting 1 year before the study intervention administration. 20. Concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). 21. For enrollment in Season 2: Previous participation (i.e., during previous season) in this clinical study. 22. Planned move during the study period that will prohibit participating in the study until study end. 23. Planned leave or holiday of 4 consecutive weeks or more during the influenza season covered by the study, that would prohibit the reporting of ILI cases and attendance to ILI visit. 24. Any study personnel or their immediate dependents, family, or household members.

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Conditions

The condition(s) this trial relates to.

influenza

As listed by the trial registrant

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

Influenza, human

How to take part

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

  1. The places running it

    163 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

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    Guntersville, Alabama, 35976-2206, United States

  • GSK Investigational Site

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    Glendale, Arizona, 85308, United States

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    Mesa, Arizona, 85206, United States

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    Mesa, Arizona, 85213, United States

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    Phoenix, Arizona, 85014, United States

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    Phoenix, Arizona, 85032, United States

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    Scottsdale, Arizona, 85250, United States

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    Scottsdale, Arizona, 85255, United States

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    Sun City, Arizona, 85351-2146, United States

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    Tempe, Arizona, 85283-1527, United States

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    Tempe, Arizona, 85284, United States

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    Tucson, Arizona, 85711, United States

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    Tucson, Arizona, 85712, United States

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    Little Rock, Arkansas, 72204, United States

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    Little Rock, Arkansas, 72205, United States

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    Dublin, California, 94568-2453, United States

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    Escondido, California, 92025, United States

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    Fair Oaks, California, 95628, United States

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    La Palma, California, 90623, United States

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    Redding, California, 96001, United States

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    Riverside, California, 92503, United States

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    Rolling Hills Estates, California, 90274-3664, United States

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    San Bernardino, California, 92408, United States

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    San Diego, California, 92103, United States

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    Walnut Creek, California, 94598, United States

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    Aurora, Colorado, 80012, United States

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    Colorado Springs, Colorado, 80909, United States

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    Stamford, Connecticut, 06905, United States

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    Waterbury, Connecticut, 06708, United States

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    Altamonte Springs, Florida, 32701, United States

  • GSK Investigational Site

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    Fort Lauderdale, Florida, 33308, United States

  • GSK Investigational Site

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    Hialeah, Florida, 33012, United States

  • GSK Investigational Site

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    Hialeah, Florida, 33016, United States

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    Homestead, Florida, 33030, United States

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    Lake Mary, Florida, 32720, United States

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    Lake Worth, Florida, 33462, United States

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    Maitland, Florida, 32751, United States

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    Melbourne, Florida, 32934-8172, United States

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    Miami, Florida, 33125, United States

  • GSK Investigational Site

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    Miami, Florida, 33126-2073, United States

  • GSK Investigational Site

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    Miami, Florida, 33130, United States

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    Miami, Florida, 33134, United States

  • GSK Investigational Site

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    Miami, Florida, 33135, United States

  • GSK Investigational Site

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    Miami, Florida, 33174, United States

  • GSK Investigational Site

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    Miami, Florida, 33176, United States

  • GSK Investigational Site

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    Miami, Florida, 33182-1420, United States

  • GSK Investigational Site

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    Miami, Florida, 33186, United States

  • GSK Investigational Site

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    Miami, Florida, 33276, United States

  • GSK Investigational Site

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    Miami Lakes, Florida, 33016-1597, United States

  • GSK Investigational Site

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    Miami Lakes, Florida, 33016, United States

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    Orlando, Florida, 32803, United States

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    Orlando, Florida, 32806, United States

  • GSK Investigational Site

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    Palmetto Bay, Florida, 33157, United States

  • GSK Investigational Site

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    Port Orange, Florida, 32127-5169, United States

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    Tamarac, Florida, 33321, United States

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    Tampa, Florida, 33614, United States

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    Tampa, Florida, 33615, United States

  • GSK Investigational Site

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    The Villages, Florida, 32162, United States

  • GSK Investigational Site

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    The Villages, Florida, 32162, United States

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    West Palm Beach, Florida, 33409, United States

  • GSK Investigational Site

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    Albany, Georgia, 31707, United States

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    Atlanta, Georgia, 30281, United States

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    Atlanta, Georgia, 30328, United States

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    Decatur, Georgia, 30030, United States

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    Marietta, Georgia, 30060, United States

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    Riverdale, Georgia, 30274, United States

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    Savannah, Georgia, 31406, United States

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    Meridian, Idaho, 83642-3154, United States

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    Chicago, Illinois, 60607-4911, United States

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    Morton, Illinois, 61550, United States

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    Peoria, Illinois, 61614, United States

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    Valparaiso, Indiana, 46383, United States

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    Kansas City, Kansas, 66112, United States

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    Lenexa, Kansas, 66219, United States

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    Lafayette, Louisiana, 70508, United States

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    Metairie, Louisiana, 70006, United States

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    New Orleans, Louisiana, 70115, United States

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    Baltimore, Maryland, 21208, United States

  • GSK Investigational Site

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    Boston, Massachusetts, 02131, United States

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    Brookline, Massachusetts, 02446, United States

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    Garden City, Michigan, 48135, United States

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    Southfield, Michigan, 48034, United States

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    Southfield, Michigan, 48075, United States

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    Gulfport, Mississippi, 39503, United States

  • GSK Investigational Site

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    Chesterfield, Missouri, 63005, United States

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    St Louis, Missouri, 63141-6282, United States

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    St Louis, Missouri, 63141, United States

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    Elkhorn, Nebraska, 68022, United States

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    Grand Island, Nebraska, 68803, United States

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    Norfolk, Nebraska, 68701-7701, United States

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    Omaha, Nebraska, 68114, United States

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    Las Vegas, Nevada, 89106, United States

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    Las Vegas, Nevada, 89109, United States

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    Warren Township, New Jersey, 07059-2730, United States

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    Santa Fe, New Mexico, 87505, United States

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    Hartsdale, New York, 10530, United States

  • GSK Investigational Site

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    Rochester, New York, 14609, United States

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    Charlotte, North Carolina, 28210, United States

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    Denver, North Carolina, 80110, United States

  • GSK Investigational Site

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    Durham, North Carolina, 27704, United States

  • GSK Investigational Site

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    Fayetteville, North Carolina, 30214, United States

  • GSK Investigational Site

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    Greensboro, North Carolina, 27408, United States

  • GSK Investigational Site

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    Hickory, North Carolina, 28601, United States

  • GSK Investigational Site

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    Raleigh, North Carolina, 27527, United States

  • GSK Investigational Site

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    Salisbury, North Carolina, 28144, United States

  • GSK Investigational Site

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    Wilmington, North Carolina, 28403, United States

  • GSK Investigational Site

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    Winston-Salem, North Carolina, 27103, United States

  • GSK Investigational Site

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    Blue Ash, Ohio, 45242-3763, United States

  • GSK Investigational Site

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    Cincinnati, Ohio, 45246, United States

  • GSK Investigational Site

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    Columbus, Ohio, 43213, United States

  • GSK Investigational Site

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    Lima, Ohio, 45801, United States

  • GSK Investigational Site

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    Chickasha, Oklahoma, 73018-2738, United States

  • GSK Investigational Site

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    Oklahoma City, Oklahoma, 73111, United States

  • GSK Investigational Site

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    Tulsa, Oklahoma, 74133, United States

  • GSK Investigational Site

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    Portland, Oregon, 97210-5311, United States

  • GSK Investigational Site

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    Camp Hill, Pennsylvania, 17011, United States

  • GSK Investigational Site

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    Philadelphia, Pennsylvania, 19107, United States

  • GSK Investigational Site

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    Anderson, South Carolina, 29621-4822, United States

  • GSK Investigational Site

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    Little River, South Carolina, 29569, United States

  • GSK Investigational Site

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    Myrtle Beach, South Carolina, 29572, United States

  • GSK Investigational Site

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    North Charleston, South Carolina, 29405, United States

  • GSK Investigational Site

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    Spartanburg, South Carolina, 29301, United States

  • GSK Investigational Site

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    Knoxville, Tennessee, 37909, United States

  • GSK Investigational Site

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    Knoxville, Tennessee, 37912, United States

  • GSK Investigational Site

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    Austin, Texas, 78704, United States

  • GSK Investigational Site

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    Austin, Texas, 78705-3214, United States

  • GSK Investigational Site

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    Brownsville, Texas, 78526, United States

  • GSK Investigational Site

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    Carrollton, Texas, 75006-2139, United States

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    Cypress, Texas, 77429, United States

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    Dallas, Texas, 75230, United States

  • GSK Investigational Site

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    Dallas, Texas, 75243-1921, United States

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    DeSoto, Texas, 75115, United States

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    Edinburg, Texas, 78539-3432, United States

  • GSK Investigational Site

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    El Paso, Texas, 79902, United States

  • GSK Investigational Site

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    Fort Worth, Texas, 76135, United States

  • GSK Investigational Site

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    Friendswood, Texas, 77546, United States

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    Garland, Texas, 75043, United States

  • GSK Investigational Site

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    Houston, Texas, 77008, United States

  • GSK Investigational Site

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    Houston, Texas, 77008, United States

  • GSK Investigational Site

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    Houston, Texas, 77040, United States

  • GSK Investigational Site

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    Houston, Texas, 77065, United States

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    Houston, Texas, 77081, United States

  • GSK Investigational Site

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    Houston, Texas, 77087, United States

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    Irving, Texas, 75061, United States

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    Keller, Texas, 76248, United States

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    Laredo, Texas, 78041, United States

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    McKinney, Texas, 75071, United States

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    Mesquite, Texas, 75149, United States

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    Pearland, Texas, 77584, United States

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    Plano, Texas, 75093, United States

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    San Antonio, Texas, 78527, United States

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    Stephenville, Texas, 76401, United States

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    The Woodlands, Texas, 77384, United States

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    Salt Lake City, Utah, 84107, United States

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    South Ogden, Utah, 84405-4869, United States

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    West Jordan, Utah, 84088, United States

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    Charlottesville, Virginia, 22911, United States

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    Newport News, Virginia, 23606, United States

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    Norfolk, Virginia, 23502-3931, United States

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    Richmond, Virginia, 23226, United States

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    Renton, Washington, 98057, United States

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    Seattle, Washington, 98104-2725, United States

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