One shot for two viruses? new combo vaccine enters early human testing
NCT ID NCT07464314
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 225 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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65 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 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, 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.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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GSK Investigational Site
RECRUITINGAnniston, Alabama, 36207, United States
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GSK Investigational Site
RECRUITINGLittle Rock, Arkansas, 72204, United States
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GSK Investigational Site
RECRUITINGFair Oaks, California, 95628, United States
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GSK Investigational Site
RECRUITINGSan Diego, California, 92123, United States
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GSK Investigational Site
RECRUITINGMiami, Florida, 33186, United States
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GSK Investigational Site
RECRUITINGMiami Lakes, Florida, 33016, United States
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GSK Investigational Site
RECRUITINGWest Palm Beach, Florida, 33409, United States
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GSK Investigational Site
RECRUITINGStockbridge, Georgia, 30281, United States
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GSK Investigational Site
RECRUITINGAustin, Texas, 78705, United States
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GSK Investigational Site
RECRUITINGCharlottesville, Virginia, 22911, United States
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GSK Investigational Site
RECRUITINGNewport News, Virginia, 23606, United States
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GSK Investigational Site
RECRUITINGSeattle, Washington, 98104, United States