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

October 16, 2025 updated by: ModernaTX, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Headlands Research Scottsdale
    • California
      • San Diego, California, United States, 92103
        • Artemis Research (Headlands)
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta (Headlands)
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research, Boise
    • Illinois
      • Melrose Park, Illinois, United States, 60160
        • DM Clinical Research - Chicago
    • Louisiana
      • Lafayette, Louisiana, United States, 70809
        • Velocity Clinical Research, Lafayette
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Velocity Clinical Research, Rockville
    • Massachusetts
      • Brookline, Massachusetts, United States, 02446
        • DM Clinical Research - Boston
    • Michigan
      • Southfield, Michigan, United States, 48076
        • DM Clinical Research - Detroit
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Velocity Clinical Research, Norfolk
    • North Carolina
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Velocity Clinical Research, Cincinnati, Mt. Auburn
      • Cincinnati, Ohio, United States, 45246
        • Velocity Clinical Research, Cincinnati, Springdale
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • DM Clinical Research - Philadelphia
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Trial Management Associates, LLC
    • Texas
      • Houston, Texas, United States, 77081
        • DM Clinical Research - Bellaire
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - Tomball

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mRNA-1083 Composition 1 Dose A Lot A
Participants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1.
Biological: mRNA-1083 Composition 1 Dose A Lot A
Sterile liquid for injection
Experimental: mRNA-1083 Composition 1 Dose A Lot B
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1.
Biological: mRNA-1083 Composition 1 Dose A Lot B
Sterile liquid for injection
Experimental: mRNA-1083 Composition 1 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.
Biological: mRNA-1083 Composition 1 Dose B
Sterile liquid for injection
Experimental: mRNA-1083 Composition 1 Dose C
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.
Biological: mRNA-1083 Composition 1 Dose C
Sterile liquid for injection
Experimental: mRNA-1083 Composition 2 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.
Biological: mRNA-1083 Composition 2 Dose A
Sterile liquid for injection
Experimental: mRNA-1083 Composition 2 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.
Biological: mRNA-1083 Composition 2 Dose B
Sterile liquid for injection
Experimental: mRNA-1083 Composition 3 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1.
Biological: mRNA-1083 Composition 3 Dose A
Sterile liquid for injection
Experimental: mRNA-1083 Composition 3 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1.
Biological: mRNA-1083 Composition 3 Dose B
Sterile liquid for injection
Active Comparator: Influenza Vaccine
Participants will receive single IM injection of Influenza Vaccine on Day 1.
Biological: Influenza Vaccine
Sterile liquid for injection
Active Comparator: COVID-19 Vaccine
Participants will receive single IM injection of COVID-19 Vaccine on Day 1.
Biological: COVID-19 Vaccine
Sterile liquid for injection
Active Comparator: Investigational Influenza Vaccine
Participants will receive single IM injection of Investigational Influenza Vaccine on Day 1.
Biological: Investigational Influenza Vaccine
Sterile liquid for injection
Active Comparator: Investigational COVID-19 Vaccine Lot A
Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1.
Biological: Investigational COVID-19 Vaccine Lot A
Sterile liquid for injection
Active Comparator: Investigational COVID-19 Vaccine Lot B
Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1.
Biological: Investigational COVID-19 Vaccine Lot B
Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Day 1 through 7 days after study injection
Day 1 through 7 days after study injection
Number of Participants With Unsolicited Adverse Events (AEs)
Time Frame: Day 1 through 28 days after study injection
Day 1 through 28 days after study injection
Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza
Time Frame: Day 29
Day 29
Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Time Frame: Day 29
Day 29
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
Time Frame: Day 1 through Day 181
Day 1 through Day 181

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay
Time Frame: Baseline (Day 1), Day 29
Baseline (Day 1), Day 29
GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA
Time Frame: Baseline (Day 1), Day 29
Baseline (Day 1), Day 29
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
Time Frame: Baseline (Day 1) to Day 29
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.
Baseline (Day 1) to Day 29
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA
Time Frame: Baseline (Day 1) to Day 29
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.
Baseline (Day 1) to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Actual)

October 13, 2025

Study Completion (Actual)

October 13, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Estimated)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 16, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1083-P202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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