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Investigating a new mRNA vaccine for influenza and COVID-19 in adults

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

Phase 2 Interventional ModernaTX, Inc. · NCT06864143

This study is testing a new mRNA vaccine that aims to protect adults from both influenza and COVID-19 to see how well it works and if there are any side effects.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment1300 (estimated)
Ages18 Years to 64 Years
SexAll
SponsorModernaTX, Inc. Industry-sponsored
Drugs / interventionsinfliximab
Locations17 sites (Scottsdale, Arizona and 16 other locations)
Trial IDNCT06864143 on ClinicalTrials.gov

What this trial studies

This study evaluates the immunogenicity, reactogenicity, and safety of the mRNA-1083 vaccine, which targets both influenza and COVID-19, in adults aged 18 to 65. Participants will receive different compositions of the vaccine to assess their immune response and any potential side effects. The study aims to determine the effectiveness of this multicomponent vaccine in providing protection against these viral infections.

Who should consider this trial

Good fit: Ideal candidates are medically stable adults aged 18 to 65 who have received at least two COVID-19 vaccinations.

Not a fit: Patients with recent influenza or SARS-CoV-2 infections, or those with unstable medical conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide enhanced protection against both influenza and COVID-19 for adults.

How similar studies have performed: Other studies on mRNA vaccines have shown promising results, indicating potential success for this novel approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Scottsdale, Arizona and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions InfluenzaSARS-CoV-2mRNA-1083COVID-19Messenger RNAModerna
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.