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

Description

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.

Conditions

Influenza, SARS-CoV-2

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Influenza
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Headlands Research Scottsdale, Scottsdale, Arizona, United States, 85260

San Diego

Artemis Research (Headlands), San Diego, California, United States, 92103

Stockbridge

Clinical Research Atlanta (Headlands), Stockbridge, Georgia, United States, 30281

Meridian

Velocity Clinical Research, Boise, Meridian, Idaho, United States, 83642

Melrose Park

DM Clinical Research - Chicago, Melrose Park, Illinois, United States, 60160

Lafayette

Velocity Clinical Research, Lafayette, Lafayette, Louisiana, United States, 70809

Rockville

Velocity Clinical Research, Rockville, Rockville, Maryland, United States, 20854

Brookline

DM Clinical Research - Boston, Brookline, Massachusetts, United States, 02446

Southfield

DM Clinical Research - Detroit, Southfield, Michigan, United States, 48076

Norfolk

Velocity Clinical Research, Norfolk, Norfolk, Nebraska, United States, 68701

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

ModernaTX, Inc.,

Study Record Dates

2025-09-03