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
Completed · Phase 2
Conditions studied: Influenza, SARS-CoV-2
In brief
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.
Key facts
- Study ID
- NCT06864143
- Run by
- ModernaTX, Inc.
- People needed
- 1320
- Starts
- 2025-03-07
- Expected to finish
- 2025-10-13
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Headlands Research Scottsdale — Scottsdale, Arizona, United States
- Artemis Research (Headlands) — San Diego, California, United States
- Clinical Research Atlanta (Headlands) — Stockbridge, Georgia, United States
- Velocity Clinical Research, Boise — Meridian, Idaho, United States
- DM Clinical Research - Chicago — Melrose Park, Illinois, United States
- Velocity Clinical Research, Lafayette — Lafayette, Louisiana, United States
- Velocity Clinical Research, Rockville — Rockville, Maryland, United States
- DM Clinical Research - Boston — Brookline, Massachusetts, United States
- DM Clinical Research - Detroit — Southfield, Michigan, United States
- Velocity Clinical Research, Norfolk — Norfolk, Nebraska, United States
- Trial Management Associates, LLC — Wilmington, North Carolina, United States
- Velocity Clinical Research, Cincinnati, Mt. Auburn — Cincinnati, Ohio, United States
- Velocity Clinical Research, Cincinnati, Springdale — Cincinnati, Ohio, United States
- DM Clinical Research - Philadelphia — Philadelphia, Pennsylvania, United States
- Trial Management Associates, LLC — Myrtle Beach, South Carolina, United States
- DM Clinical Research - Bellaire — Houston, Texas, United States
- DM Clinical Research - Tomball — Tomball, Texas, United States
Full record on ClinicalTrials.gov
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