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InfluenzaPhase 2NCT06864143

A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age

A Phase 2 study testing mRNA-1083 Composition 1 Dose A Lot A, mRNA-1083 Composition 1 Dose A Lot B and mRNA-1083 Composition 1 Dose B in people with Influenza and SARS-CoV-2, run by ModernaTX, Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to <65 years of age. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, SARS-CoV-2
What is being tested?
mRNA-1083 Composition 1 Dose A Lot A, mRNA-1083 Composition 1 Dose A Lot B and mRNA-1083 Composition 1 Dose B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,320 participants
Where
17 sitesUnited States
Study dates
7 Mar 2025to 13 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • DM Clinical Research - Boston

    Brookline, Massachusetts, 02446

  • Velocity Clinical Research, Cincinnati, Mt. Auburn

    Cincinnati, Ohio, 45219

  • Velocity Clinical Research, Cincinnati, Springdale

    Cincinnati, Ohio, 45246

  • DM Clinical Research - Bellaire

    Houston, Texas, 77081

  • Velocity Clinical Research, Lafayette

    Lafayette, Louisiana, 70809

  • DM Clinical Research - Chicago

    Melrose Park, Illinois, 60160

  • Velocity Clinical Research, Boise

    Meridian, Idaho, 83642

  • Trial Management Associates, LLC

    Myrtle Beach, South Carolina, 29572

  • Velocity Clinical Research, Norfolk

    Norfolk, Nebraska, 68701

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Velocity Clinical Research, Rockville

    Rockville, Maryland, 20854

  • Artemis Research (Headlands)

    San Diego, California, 92103

  • Headlands Research Scottsdale

    Scottsdale, Arizona, 85260

  • DM Clinical Research - Detroit

    Southfield, Michigan, 48076

  • Clinical Research Atlanta (Headlands)

    Stockbridge, Georgia, 30281

  • DM Clinical Research - Tomball

    Tomball, Texas, 77375

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Observer-blind, Active-control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age

The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to <65 years of age.

Being tested
mRNA-1083 Composition 1 Dose A Lot A, mRNA-1083 Composition 1 Dose A Lot B, mRNA-1083 Composition 1 Dose B, mRNA-1083 Composition 1 Dose C, mRNA-1083 Composition 2 Dose A
Keywords
Influenza, SARS-CoV-2, mRNA-1083, COVID-19, Messenger RNA, Moderna
Medical subject headings
Influenza, Human, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1083 Composition 1 Dose A Lot ABiological

    Sterile liquid for injection

  • mRNA-1083 Composition 1 Dose A Lot BBiological

    Sterile liquid for injection

  • mRNA-1083 Composition 1 Dose BBiological

    Sterile liquid for injection

  • mRNA-1083 Composition 1 Dose CBiological

    Sterile liquid for injection

  • mRNA-1083 Composition 2 Dose ABiological

    Sterile liquid for injection

  • mRNA-1083 Composition 2 Dose BBiological

    Sterile liquid for injection

  • mRNA-1083 Composition 3 Dose ABiological

    Sterile liquid for injection

  • mRNA-1083 Composition 3 Dose BBiological

    Sterile liquid for injection

  • Influenza VaccineBiological

    Sterile liquid for injection

  • COVID-19 VaccineBiological

    Sterile liquid for injection

  • Investigational Influenza VaccineBiological

    Sterile liquid for injection

  • Investigational COVID-19 Vaccine Lot ABiological

    Sterile liquid for injection

  • Investigational COVID-19 Vaccine Lot BBiological

    Sterile liquid for injection

Study groups in NCT06864143
Study groupRoleWhat they receive
mRNA-1083 Composition 1 Dose A Lot AExperimentalParticipants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1.
Receives: Biological: mRNA-1083 Composition 1 Dose A Lot A
mRNA-1083 Composition 1 Dose A Lot BExperimentalParticipants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1.
Receives: Biological: mRNA-1083 Composition 1 Dose A Lot B
mRNA-1083 Composition 1 Dose BExperimentalParticipants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.
Receives: Biological: mRNA-1083 Composition 1 Dose B
mRNA-1083 Composition 1 Dose CExperimentalParticipants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.
Receives: Biological: mRNA-1083 Composition 1 Dose C
mRNA-1083 Composition 2 Dose AExperimentalParticipants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.
Receives: Biological: mRNA-1083 Composition 2 Dose A
mRNA-1083 Composition 2 Dose BExperimentalParticipants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.
Receives: Biological: mRNA-1083 Composition 2 Dose B
mRNA-1083 Composition 3 Dose AExperimentalParticipants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1.
Receives: Biological: mRNA-1083 Composition 3 Dose A
mRNA-1083 Composition 3 Dose BExperimentalParticipants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1.
Receives: Biological: mRNA-1083 Composition 3 Dose B
Influenza VaccineActive comparatorParticipants will receive single IM injection of Influenza Vaccine on Day 1.
Receives: Biological: Influenza Vaccine
COVID-19 VaccineActive comparatorParticipants will receive single IM injection of COVID-19 Vaccine on Day 1.
Receives: Biological: COVID-19 Vaccine
Investigational Influenza VaccineActive comparatorParticipants will receive single IM injection of Investigational Influenza Vaccine on Day 1.
Receives: Biological: Investigational Influenza Vaccine
Investigational COVID-19 Vaccine Lot AActive comparatorParticipants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1.
Receives: Biological: Investigational COVID-19 Vaccine Lot A
Investigational COVID-19 Vaccine Lot BActive comparatorParticipants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1.
Receives: Biological: Investigational COVID-19 Vaccine Lot B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza

    Measured: Day 29

  2. Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

    Measured: Day 29

  3. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

    Measured: Day 1 through 7 days after study injection

  4. Number of Participants With Unsolicited Adverse Events (AEs)

    Measured: Day 1 through 28 days after study injection

  5. Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation From the Study

    Measured: Day 1 through Day 181

Secondary outcomes (4)

  1. Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay

    Measured: Baseline (Day 1), Day 29

  2. GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA

    Measured: Baseline (Day 1), Day 29

  3. Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay

    Seroconversion is defined as postinjection level ≥1:40 if baseline is <1:10 or at least a 4-fold rise if baseline is ≥1:10 in HAI antibody titer.

    Measured: Baseline (Day 1) to Day 29

  4. SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA

    Seroresponse is defined as PsVNA concentration change from preinjection baseline below the lower limit of quantification (LLOQ) to postinjection ≥4×LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ.

    Measured: Baseline (Day 1) to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start7 Mar 2025
  3. Primary completion13 Oct 2025
  4. Study completion13 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06864143
Sponsor's protocol ID
mRNA-1083-P202
Status last verified
Oct 2025
First submitted
5 Mar 2025
Last updated
20 Oct 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mRNA-1083 Composition 1 Dose A Lot A, mRNA-1083 Composition 1 Dose A Lot B and mRNA-1083 Composition 1 Dose B in people with Influenza and SARS-CoV-2, run by ModernaTX, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza (time frame: Day 29). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06864143.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

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