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

A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adults ≥50 Years of Age

Phase 3 Interventional ModernaTX, Inc. · NCT06694389

This study is testing a new vaccine for COVID-19 and the flu in adults aged 50 and older to see how well it works and if it's safe.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2450 (estimated)
Ages50 Years and up
SexAll
SponsorModernaTX, Inc. Industry-sponsored
Drugs / interventionsinfliximab, prednisone
Locations45 sites (Nagoya-shi, Aichi and 44 other locations)
Trial IDNCT06694389 on ClinicalTrials.gov

What this trial studies

This study evaluates the immunogenicity, reactogenicity, and safety of the mRNA-1083 vaccine in adults aged 50 and older. Participants will receive either the mRNA-1083 vaccine, a placebo, or a licensed influenza vaccine. The study aims to determine how well the vaccine works and its safety profile in this age group across Japan, Taiwan, and South Korea. The trial is designed to gather important data that could inform future vaccination strategies for older adults.

Who should consider this trial

Good fit: Ideal candidates for this study are medically stable adults aged 50 years and older.

Not a fit: Patients who are currently pregnant or breastfeeding may not benefit from this study.

Why it matters

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

How similar studies have performed: Other studies have shown promise in using mRNA technology for vaccines, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Medically stable adults ≥50 years of age at the time of consent (Screening/Day 1 Visit).
* A participant who could become pregnant is eligible to participate if the following is met:

  * Not pregnant or breast/chestfeeding, and is using a contraceptive method that is highly effective for at least 90 days after the study intervention administration and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
  * Have a negative highly sensitive pregnancy test (urine) as required by local regulations at Screening/Day 1 Visit, before the study intervention.
* Participants who can produce sperm are eligible to participate if they agree to the following for at least 90 days after the study intervention administration:

  * Refrain from donating sperm.
  * Either be abstinent from reproductive sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use an external condom with a person who could become pregnant partner use of an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse.
* Agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person.
* Received ≥2 COVID-19 vaccines and the last COVID-19 vaccine was ≥150 days prior to Day 1

Key Exclusion Criteria:

* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
* 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.
* Known history of SARS-CoV-2 infection within 150 days prior to Day 1.
* Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
* Received corticosteroids at ≥10 mg/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study. Inhaled nasal and topical steroids are allowed.
* Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, 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 ≤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.
* Treated with antiviral therapies for influenza (for example, Tamiflu®) ≤150 days prior to Day 1.
* Has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu) within 5 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/Day 1 or plans to donate blood products during the study.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Nagoya-shi, Aichi and 44 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 COVID-19InfluenzaMessenger 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.