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OpenTrials
Completed

NCT Number: NCT06694389

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age

The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Daido Clinic, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mRNA-1083

Biological

Suspension for injection

Placebo

Other

0.9% sodium chloride suspension for injection

Licensed influenza vaccine

Biological

Aqueous injectable (SC) or suspension for injection (IM)

Other names: Influenza HA, Biken, and, Fluarix tetra

SARS-CoV-2 vaccine

Biological

Suspension for injection

Other names: mRNA-1273

Primary outcomes

  1. Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay

    Time frame: Day 29

  2. GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)

    Time frame: Day 29

  3. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

    Time frame: Day 1 through 7 days after study injection

  4. Number of Participants With Unsolicited Adverse Events (AEs)

    Time frame: Day 1 through 28 days after study injection

  5. Number of Participants With Medically Attended Adverse Events (MAAEs)

    Time frame: Day 1 though Day 181

  6. Number of Participants With Adverse Events of Special Interest (AESIs)

    Time frame: Day 1 though Day 181

  7. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Day 1 through Day 181

  8. Number of Participants With AEs Leading to Discontinuation

    Time frame: Day 1 through Day 181

Secondary outcomes

  1. Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay

    Time frame: Day 29

    Seroconversion is defined as a Day 29 post-injection level ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.

  2. SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA

    Time frame: Day 29

    Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is <LLOQ in neutralizing antibody (nAb) values measured by PsVNA.

  3. Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay

    Time frame: Day 1, Day 29

  4. GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA

    Time frame: Day 1, Day 29

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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