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One shot for two viruses? moderna tests combo mRNA vaccine

NCT ID NCT05827926

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested several experimental mRNA vaccines that aim to protect against both influenza and SARS-CoV-2 in a single injection. About 1,758 healthy adults aged 18 to under 80 took part. The main goals were to check safety and measure the immune response, with results helping to pick the best vaccine formula for larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-based influenza and SARS-CoV-2 multi-component vaccines
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 schedules.
What could go wrong
This is an early phase 1/2 trial, so the vaccines may not prove effective in larger studies. Side effects like injection site pain, fever, and fatigue are common with mRNA 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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

1,758 people

The number who actually took part.

Started

Apr 2023

Finished

Dec 2024

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

18 to 79 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.

Key Inclusion Criteria: Part 1 (Phase 1/2) * Adults ≥18 to \<80 years of age at the time of consent. * Body mass index (BMI) of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit. * Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests. * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding. * Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥120 days prior to Day 1. Part 2 (Phase 2 Extension) * Adults ≥18 to \<50 years of age at the time of consent. * BMI of 18 kg/m\^2 to 35 kg/m\^2 (inclusive) at the Screening Visit. * Healthy as determined by medical evaluation, including medical history, and physical examination. * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding. * Have received at least 2 doses of locally authorized or approved COVID-19 vaccines and last dose was ≥90 days prior to Day 1. Key Exclusion Criteria: Part 1 (Phase 1/2) and Part 2 (Phase 2 Extension) * Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1. * Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. * Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed. * Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. * Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1. * Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1. * Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1. * Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the clinical trial. * Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home. Part 2 (Phase 2 Extension) Only * Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study. Note: Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease viral infectious disease 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

  • Accel Research Site

    Decatur, Georgia, 30030-2615, United States

  • Accel Research Sites

    DeLand, Florida, 32720-0834, United States

  • Accel Research Sites

    Maitland, Florida, 32751, United States

  • Annapolis Internal Medicine

    Annapolis, Maryland, 21401, United States

  • Benchmark Research

    Colton, California, 92324, United States

  • Benchmark Research

    Sacramento, California, 95864-3102, United States

  • Benchmark Research

    Metairie, Louisiana, 70006, United States

  • Benchmark Research

    Austin, Texas, 78705-3298, United States

  • Benchmark Research

    Fort Worth, Texas, 76135, United States

  • Benchmark Research

    San Angelo, Texas, 76904-7610, United States

  • CCT Research

    Las Vegas, Nevada, 89119, United States

  • CCT Research

    Pleasant View, Utah, 84404, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • CenExel

    Hollywood, Florida, 33024, United States

  • CenExel iResearch

    Decatur, Georgia, 30030, United States

  • Central Valley Research

    Modesto, California, 95350-5365, United States

  • Centricity Research

    Columbus, Georgia, 31904, United States

  • Centricity Research

    Columbus, Ohio, 43213, United States

  • Chandler Clinical Trials

    Chandler, Arizona, 85224-6231, United States

  • Clay Platte Family Medicine

    Kansas City, Missouri, 64151-2411, United States

  • Cyfair Clinical Research

    Houston, Texas, 77065, United States

  • DM Clinical Research

    River Forest, Illinois, 60305-1876, United States

  • DM Clinical Research

    Brookline, Massachusetts, 02445-7113, United States

  • DM Clinical Research

    Philadelphia, Pennsylvania, 19107-1530, United States

  • DelRicht Research

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research

    Prairieville, Louisiana, 70769, United States

  • DelRicht Research

    Gulfport, Mississippi, 39503, United States

  • DelRicht Research

    Tulsa, Oklahoma, 74133, United States

  • DelRicht Research

    Charleston, South Carolina, 29407, United States

  • DelRicht Research

    Hendersonville, Tennessee, 37075, United States

  • DelRicht Research

    McKinney, Texas, 75070, United States

  • Excel Clinical Research

    Las Vegas, Nevada, 89109-6209, United States

  • JBR Clinical Research

    Salt Lake City, Utah, 84107, United States

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida, 32216, United States

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219-1389, United States

  • Koch Family Medicine

    Morton, Illinois, 61550, United States

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030-7193, United States

  • Lifeline Primary Care

    Lilburn, Georgia, 30047-2832, United States

  • Lynn Institute of East Oklahoma

    Oklahoma City, Oklahoma, 73111-3324, United States

  • Marvel Clinical Research

    Huntington Beach, California, 92647-6835, United States

  • Medical Care

    Elizabethton, Tennessee, 37643, United States

  • Mercado Medical Practice

    Philadelphia, Pennsylvania, 19111-2432, United States

  • Meridian Clinical Research

    Hampton, Virginia, 23666, United States

  • Nature Coast Clinical Research

    Inverness, Florida, 34452, United States

  • Ogden Clinic

    Roy, Utah, 84067, United States

  • Optimal Research

    Peoria, Illinois, 61614-4885, United States

  • Rochester Clinical Research

    Rochester, New York, 14609-3169, United States

  • Suncoast Research Group

    Miami, Florida, 33135-1687, United States

  • Tekton Research

    Longmont, Colorado, 80501-6461, United States

  • Tekton Research

    Wichita, Kansas, 67218-2913, United States

  • Tekton Research

    Austin, Texas, 78745-1470, United States

  • Tekton Research

    Beaumont, Texas, 77706-3061, United States

  • Tekton Research

    San Antonio, Texas, 78229, United States

  • Tekton Research Inc

    Yukon, Oklahoma, 73099-9518, United States

  • Texas Center for Drug Development

    Houston, Texas, 77081, United States

  • Trial Management Associates

    Wilmington, North Carolina, 28403-6238, United States

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572-4612, United States

  • Tryon Medical Partners

    Charlotte, North Carolina, 28210, United States

  • Velocity Clinical Research

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research

    Lincoln, Nebraska, 68510, United States

  • Velocity Clinical Research

    Norfolk, Nebraska, 68701, United States

  • Velocity Clinical Research

    Cincinnati, Ohio, 45219, United States

  • Velocity Clinical Research

    Cincinnati, Ohio, 45246, United States

  • Velocity Clinical Research

    Portsmouth, Virginia, 23703, United States

  • Velocity Clinical research

    Baton Rouge, Louisiana, 70809, United States

  • Versailles Family Medicine

    Versailles, Kentucky, 40383-1947, United States

  • Vida Clinical Studies

    Dearborn Heights, Michigan, 48127-2234, United States

  • WellNow Urgent Care & Research

    Dayton, Ohio, 45424-4019, United States

  • Wenatchee Valley Hospital & Clinics Campus

    Wenatchee, Washington, 98801, United States

More trials for these conditions

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