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

Launched by MODERNATX, INC. · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new vaccine called mRNA-1083, which combines protection against both influenza (the flu) and COVID-19. The goal is to see how well this vaccine works (immunogenicity), how it affects people's bodies (reactogenicity), and whether it is safe for adults between 18 and 65 years old. If you're healthy and have received at least two COVID-19 vaccines, with the last one given more than 150 days before joining the study, you might be eligible to participate. Participants will need to be stable in their health and follow certain guidelines, like not receiving other vaccines immediately before or after the study.

If you decide to take part in this trial, you will receive the mRNA-1083 vaccine and be monitored for any side effects or reactions. This is a great opportunity to contribute to important research that could help protect against both the flu and COVID-19 in the future. Remember, they are currently looking for volunteers, so if you think you qualify and are interested, don't hesitate to reach out for more information!

Gender

ALL

Eligibility criteria

• 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.