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

Last updated: March 19, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Covid-19

Influenza

Sars-cov-2

Treatment

COVID-19 Vaccine

Investigational Influenza Vaccine

mRNA-1083 Composition 1 Dose B

Clinical Study ID

NCT06864143
mRNA-1083-P202
  • Ages 18-64
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medically stable.

  • Participants who could become pregnant: negative pregnancy test and contraceptionfor at least 28 days prior to Day 1 and for at least 90 days after the studyintervention administration.

  • Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with the lastCOVID-19 vaccine administered >150 days prior to Day 1.

Exclusion

Exclusion Criteria:

  • History of a diagnosis or condition that is clinically unstable or may affectparticipant safety, assessment of study endpoints, assessment of immune response, oradherence to study procedures.

  • Tested positive for influenza by local health authority-approved testing methodswithin 150 days prior to Day 1.

  • History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectionwithin 150 days prior to Day 1.

  • Received systemic immunosuppressive treatment, including long-acting biologicaltherapies that affect immune responses (eg, infliximab), within 180 days prior toDay 1 or plans to do so during the study.

  • Received or plans to receive any vaccine authorized or approved by a local healthagency within 28 days prior to Day 1 or plans to do so within 28 days post studyinjection.

  • 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, orinvestigational combination vaccine for influenza and COVID-19 within 12 monthsprior to Day 1.

  • Participated in a clinical study with investigational treatment within 90 days priorto Day 1 (Baseline).

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 1300
Treatment Group(s): 13
Primary Treatment: COVID-19 Vaccine
Phase: 2
Study Start date:
March 07, 2025
Estimated Completion Date:
September 03, 2025

Connect with a study center

  • Headlands Research Scottsdale

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Artemis Research (Headlands)

    San Diego, California 92103
    United States

    Site Not Available

  • Clinical Research Atlanta (Headlands)

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Velocity Clinical Research, Boise

    Meridian, Idaho 83642
    United States

    Site Not Available

  • DM Clinical Research - Chicago

    Melrose Park, Illinois 60160
    United States

    Site Not Available

  • Velocity Clinical Research, Lafayette

    Lafayette, Louisiana 70809
    United States

    Site Not Available

  • Velocity Clinical Research, Rockville

    Rockville, Maryland 20854
    United States

    Site Not Available

  • DM Clinical Research - Boston

    Brookline, Massachusetts 02446
    United States

    Site Not Available

  • DM Clinical Research - Detroit

    Southfield, Michigan 48076
    United States

    Site Not Available

  • Velocity Clinical Research, Norfolk

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Trial Management Associates, LLC

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Velocity Clinical Research, Cincinnati, Mt. Auburn

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Velocity Clinical Research, Cincinnati, Springdale

    Cincinnati, Ohio 45246
    United States

    Site Not Available

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Trial Management Associates, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • DM Clinical Research - Bellaire

    Houston, Texas 77081
    United States

    Site Not Available

  • DM Clinical Research - Tomball

    Tomball, Texas 77375
    United States

    Site Not Available

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