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One shot for two viruses: new combo vaccine trial shows promise

NCT ID NCT06508320

Vaccine Sponsor: ModernaTX, Inc. 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single shot that aims to protect against both COVID-19 and the flu. About 932 adults aged 50 to 64 received the experimental mRNA-1083 vaccine. Researchers checked for side effects and measured antibody levels one month after vaccination to see how well the vaccine worked.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

932 people

The number who actually took part.

Started

Jul 2024

Finished

Sep 2025

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

50 to 64 years

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. Investigator assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. 2. Participants of nonchildbearing potential may be enrolled in the study. 3. Participants who could become pregnant: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy. 4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. 5. Have received an influenza vaccine in the previous season (since September 2023 for Part 1, since Sep 2024 for Part 2). Exclusion Criteria: 1. Reported diagnosis or condition that is associated with increased risk of severe influenza disease or complications, including individuals with chronic medical conditions. 2. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections. 3. History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein. 4. Received corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study. 5. Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (e.g., infliximab), within 180 days prior to Day 1 or plans to do so during the study. 6. 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. 7. Received a licensed seasonal influenza vaccine within 150 days prior to Day 1. 8. Received a licensed/authorized SARS-CoV-2 vaccine within 90 days prior to Day 1. 9. Received any investigational influenza vaccine, investigational coronavirus disease 2019 (COVID-19) vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1. Participants from mRNA-1083-P201 Part 1 will also be excluded from Part 2. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target influenza prevention target

As listed by the trial registrant

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

Influenza SARS-CoV-2

Contacts and locations

Locations

  • Cenexel IRA

    Decatur, Georgia, 30030, United States

  • Cenexel RCA

    Hollywood, Florida, 33024, United States

  • Centricity Research

    Toronto, Ontario, M4G 3E8, Canada

  • Centricity Research

    Toronto, Ontario, M9W 4L6, Canada

  • Centricity Research

    Pointe-Claire, Quebec, H9R4S3, Canada

  • Clinical Trials of Texas, LLC DBA Flourish Research

    San Antonio, Texas, 78229, United States

  • DM Clinical Research - Cyfair Clinical Research Center - PPDS

    Houston, Texas, 77065-5685, United States

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107, United States

  • DM Clinical Research - River Forest

    River Forest, Illinois, 60305, United States

  • DM Clinical Research - Sugarland

    Sugar Land, Texas, 77478, United States

  • DM Clinical Research - Tomball MDC

    Tomball, Texas, 77375, United States

  • Diex Recherche Québec Inc.

    Québec, G1V 4T3, Canada

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8, Canada

  • Hassman Research Institute - Berlin - CenExel - PPDS

    Marlton, New Jersey, 80530, United States

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012, United States

  • JCCT

    Lenexa, Kansas, 66219, United States

  • Suncoast Research Group, LLC DBA Flourish Research

    Miami, Florida, 33135, United States

More trials for these conditions

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