A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

Completed · Phase 3 · Has a placebo group

Conditions studied: SARS-CoV-2, Influenza

In brief

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to \<65 years of age (Cohort B).

Key facts

Study ID

NCT06097273

Run by

ModernaTX, Inc.

People needed

8061

Starts

2023-10-19

Expected to finish

2024-05-28

Last updated by the study team

2025-07-01

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
• Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
• Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.
• Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
• Received a seasonal influenza vaccine ≤150 days prior to Day 1.
• Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
• Has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
• Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
• Note: Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Accel Research Site - Achieve - Birmingham — Birmingham, Alabama, United States
• Cullman Clinical Trials — Cullman, Alabama, United States
• Desert Clinical Research - CCT - PPDS — Mesa, Arizona, United States
• Foothills Research Center - CCT - PPDS — Phoenix, Arizona, United States
• Headlands Research - Scottsdale - PPDS — Scottsdale, Arizona, United States
• Scottsdale Clinical Trials — Scottsdale, Arizona, United States
• Fiel Family & Sports Medicine - PC - CCT - PPDS — Tempe, Arizona, United States
• AES - DRS - Synexus Clinical Research US, Inc. - Cerritos — Cerritos, California, United States
• Long Beach Research Institute, LLC — Long Beach, California, United States
• CenExel Apex (CNS) - Los Alamitos - PPDS — Los Alamitos, California, United States
• Central Valley Research, LLC — Modesto, California, United States
• Carbon Health- NoHo West Urgent Care and Primary Care — North Hollywood, California, United States
• Empire Clinical Research — Pomona, California, United States
• Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS — Riverside, California, United States
• Clinical Innovations Trials - Riverside - CenExel - PPDS — Riverside, California, United States
• Peninsula Research Associates - Headlands - PPDS — Rolling Hills Estates, California, United States
• Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS — San Diego, California, United States
• AES - DRS - Synexus Clinical Research US, Inc. - Vista — Vista, California, United States
• Tekton Research - Fort Collins - PPDS — Fort Collins, Colorado, United States
• Tekton Research - Longmont - PPDS — Longmont, Colorado, United States
• Stamford Therapeutics Consortium - ERN - PPDS — Stamford, Connecticut, United States
• Chase Medical Research LLC - Waterbury — Waterbury, Connecticut, United States
• Revival Research Corporation — Doral, Florida, United States
• Indago Research and Health Center — Hialeah, Florida, United States
• Pinnacle Research Group-409 E 10th St — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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