One shot for two viruses: new combo vaccine trial shows promise
NCT ID NCT06864143
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new combination vaccine called mRNA-1083 that aims to protect against both flu and COVID-19 in a single shot. About 1,320 adults aged 18 to 64 took part. Researchers measured the immune response and checked for side effects to see if the combo vaccine works as well as separate vaccines.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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1,320 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Oct 2025
- 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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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Medically stable. * Participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to Day 1 and for at least 90 days after the study intervention administration. * Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with the last COVID-19 vaccine administered \>150 days prior to Day 1. Exclusion Criteria: * History of a diagnosis or condition that is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * Tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1. * History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 150 days prior to Day 1. * Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 or plans to do so during the study. * Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection. * Received a licensed seasonal influenza vaccine within 150 days prior to Day 1. * Received a licensed/authorized COVID-19 vaccine within 150 days prior to Day 1. * Received any investigational influenza vaccine, investigational COVID-19 vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1. * Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline). Other protocol-defined inclusion/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.
Contacts and locations
Locations
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Artemis Research (Headlands)
San Diego, California, 92103, United States
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Clinical Research Atlanta (Headlands)
Stockbridge, Georgia, 30281, United States
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DM Clinical Research - Bellaire
Houston, Texas, 77081, United States
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DM Clinical Research - Boston
Brookline, Massachusetts, 02446, United States
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DM Clinical Research - Chicago
Melrose Park, Illinois, 60160, United States
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DM Clinical Research - Detroit
Southfield, Michigan, 48076, United States
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DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
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DM Clinical Research - Tomball
Tomball, Texas, 77375, United States
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Headlands Research Scottsdale
Scottsdale, Arizona, 85260, United States
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Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
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Trial Management Associates, LLC
Myrtle Beach, South Carolina, 29572, United States
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Velocity Clinical Research, Boise
Meridian, Idaho, 83642, United States
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Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, 45219, United States
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Velocity Clinical Research, Cincinnati, Springdale
Cincinnati, Ohio, 45246, United States
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Velocity Clinical Research, Lafayette
Lafayette, Louisiana, 70809, United States
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Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701, United States
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Velocity Clinical Research, Rockville
Rockville, Maryland, 20854, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- When the immune system Can't fight back: tracking three respiratory viruses
- Flu's journey: scientists track how influenza passes between people
- Moderna tests Next-Generation mRNA COVID shot in babies and kids
- Can an old malaria drug help fight severe COVID-19?
- Can a stronger flu shot boost immunity in older adults?
- A nudge in the mailbox: could a letter boost flu shots for millions at risk?