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

Last updated: December 1, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Completed

Phase

3

Condition

Influenza

Covid-19

Treatment

SARS-CoV-2 Vaccine

Licensed Influenza Vaccine

mRNA-1083

Clinical Study ID

NCT06694389
mRNA-1083-P302
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Medically stable adults ≥50 years of age at the time of consent (Screening/Day 1Visit).

  • A participant who could become pregnant is eligible to participate if the followingis met:

  • Not pregnant or breast/chestfeeding, and is using a contraceptive method thatis highly effective for at least 90 days after the study interventionadministration and agrees not to donate eggs (ova, oocytes) for the purpose ofreproduction during this period.

  • Have a negative highly sensitive pregnancy test (urine) as required by localregulations at Screening/Day 1 Visit, before the study intervention.

  • Participants who can produce sperm are eligible to participate if they agree to thefollowing for at least 90 days after the study intervention administration:

  • Refrain from donating sperm.

  • Either be abstinent from reproductive sexual intercourse as their preferred andusual lifestyle (abstinent on a long term and persistent basis) and agree toremain abstinent or must agree to use an external condom with a person whocould become pregnant partner use of an additional highly effectivecontraceptive method with a failure rate of <1% per year when having sexualintercourse.

  • Agree to use an external condom when engaging in any activity that allows forpassage of ejaculate to another person.

  • Received ≥2 COVID-19 vaccines and the last COVID-19 vaccine was ≥150 days prior toDay 1

Exclusion

Key Exclusion Criteria:

  • History of a diagnosis or condition that, in the judgment of the Investigator, isclinically 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 ofdrug or alcohol abuse, that, in the opinion of the Investigator, might poseadditional risk due to participation in the study or could interfere with theinterpretation 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 intotal within 90 days prior to Day 1 or is anticipating the need for corticosteroidsat any time during the study. Inhaled nasal and topical steroids are allowed.

  • Received systemic immunosuppressive treatment, including long-acting biologicaltherapies that affect immune responses (for example, infliximab), within 180 daysprior to Day 1 or plans to do so during the study.

  • Received or plans to receive any vaccine authorized or approved by a local healthagency ≤28 days prior to study injections or plans to receive a vaccine authorizedor 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 daysprior to Day 1.

  • Has had close contact with someone with laboratory-confirmed influenza infection orwith someone who has been treated with antiviral therapies for influenza (forexample, Tamiflu) within 5 days prior to Day 1

  • Has had close contact to someone with COVID-19 as defined by the Centers for DiseaseControl 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 theScreening Visit/Day 1 or plans to donate blood products during the study.

  • Reported history of anaphylaxis or severe hypersensitivity reaction after receipt ofany 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.

Study Design

Total Participants: 2457
Treatment Group(s): 4
Primary Treatment: SARS-CoV-2 Vaccine
Phase: 3
Study Start date:
November 18, 2024
Estimated Completion Date:
November 17, 2025

Connect with a study center

  • Daido Clinic

    Nagoya-shi, Aichi 457-8511
    Japan

    Site Not Available

  • Public Health Association.Inc.

    Nagoya-shi, Aichi 453-0804
    Japan

    Site Not Available

  • Daido Clinic

    Nagoya 1856057, Aichi-ken 1865694 457-8511
    Japan

    Site Not Available

  • Public Health Association.Inc.

    Nagoya 1856057, Aichi-ken 1865694 453-0804
    Japan

    Site Not Available

  • Fukuoka Heartnet Hospital

    Fukuoka-shi, Fukuoka 819-0002
    Japan

    Site Not Available

  • PS Clinic - Internal medicine

    Fukuoka-shi, Fukuoka 812-0025
    Japan

    Site Not Available

  • Tenjin Sogo Clinic

    Fukuoka-shi, Fukuoka 810-0021
    Japan

    Site Not Available

  • Fukuoka Heartnet Hospital

    Fukuoka 1863967, Fukuoka 1863958 819-0002
    Japan

    Site Not Available

  • PS Clinic - Internal medicine

    Fukuoka 1863967, Fukuoka 1863958 812-0025
    Japan

    Site Not Available

  • Tenjin Sogo Clinic

    Fukuoka 1863967, Fukuoka 1863958 810-0021
    Japan

    Site Not Available

  • Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical

    Sapporo-shi, Hokkaido 060-0011
    Japan

    Site Not Available

  • Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical

    Sapporo 2128295, Hokkaido 2130037 060-0011
    Japan

    Site Not Available

  • Motomachi Takatsuka Naika Clinic - Internal Medicine

    Yokohama-shi, Kanagawa 231-0023
    Japan

    Site Not Available

  • Motomachi Takatsuka Naika Clinic - Internal Medicine

    Yokohama 1848354, Kanagawa 1860291 231-0023
    Japan

    Site Not Available

  • Nishi-Kumamoto Hospital

    Kumamoto-shi, Kumamoto 861-4157
    Japan

    Site Not Available

  • Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic

    Kumamoto-shi, Kumamoto 860-0833
    Japan

    Site Not Available

  • Nishi-Kumamoto Hospital

    Kumamoto 1858421, Kumamoto 1858419 861-4157
    Japan

    Site Not Available

  • Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic

    Kumamoto 1858421, Kumamoto 1858419 860-0833
    Japan

    Site Not Available

  • Sato Hospital

    Osaki-shi, Miyagi 2111888 989-6143
    Japan

    Site Not Available

  • Yokoi Medicine Clinic

    Mino, Osaka 1853904 562-0003
    Japan

    Site Not Available

  • Shimamura Memorial Hospital

    Nerima, Tokyo 177-0051
    Japan

    Site Not Available

  • Denenchofu Family Clinic

    Ota-ku, Tokyo 145-0071
    Japan

    Site Not Available

  • Clinical Research Tokyo Hospital - Clinical Research Center

    Shinjuku, Tokyo 160-0004
    Japan

    Site Not Available

  • Higashi-Shinjuku Clinic - Internal Medicine

    Shinjuku, Tokyo 169-0072
    Japan

    Site Not Available

  • Shinwakai Adachi Kyosai Hospital - Internal Medicine

    Adachi-ku, Tokyo 1850144 120-0022
    Japan

    Site Not Available

  • Dojinkinenkai Meiwa Hospital

    Chiyoda-ku, Tokyo 1850144 101-0041
    Japan

    Site Not Available

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Chuo-ku, Tokyo 1850144 104-0031
    Japan

    Site Not Available

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo 1850144 103-0025
    Japan

    Site Not Available

  • Tokyo center clinic - Internal medicine

    Chuo-ku, Tokyo 1850144 103-0027
    Japan

    Site Not Available

  • New Medical Research System Clinic

    Hachioji-shi, Tokyo 1850144 192-0046
    Japan

    Site Not Available

  • Shimamura Memorial Hospital

    Nerima City 11790394, Tokyo 1850144 177-0051
    Japan

    Site Not Available

  • Hillside Clinic Jingumae

    Shibuya-ku, Tokyo 1850144 150-0001
    Japan

    Site Not Available

  • Clinical Research Tokyo Hospital - Clinical Research Center

    Shinjuku 11790353, Tokyo 1850144 160-0004
    Japan

    Site Not Available

  • Higashi-Shinjuku Clinic - Internal Medicine

    Shinjuku 11790353, Tokyo 1850144 169-0072
    Japan

    Site Not Available

  • Shinei Medical Healthcare Clinic

    Suginami, Tokyo 1850144 166-0003
    Japan

    Site Not Available

  • Souseikai Sumida Hospital

    Sumida-Ku, Tokyo 1850144 130-0004
    Japan

    Site Not Available

  • Seishukai Clinic

    Taito-ku, Tokyo 1850144 111-0036
    Japan

    Site Not Available

  • Metropolitan Clinic - Internal Medicine

    Toshima-ku, Tokyo 1850144 171-0021
    Japan

    Site Not Available

  • Denenchofu Family Clinic

    Ōta-ku 8469289, Tokyo 1850144 145-0071
    Japan

    Site Not Available

  • Korea University Ansan Hospital

    Ansan-si, 15355
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 14584
    Korea, Republic of

    Site Not Available

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital - Infectious Diseases

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital - Allergology

    Gwangju, 61469
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • Yonsei University, Wonju Severance Christian Hospital

    Wonju,
    Korea, Republic of

    Site Not Available

  • Korea University Ansan Hospital

    Ansan-si 1846918, 15355
    South Korea

    Site Not Available

  • Kyungpook National University Hospital - Infectious Diseases

    Daegu 1835329,
    South Korea

    Site Not Available

  • Chonnam National University Hospital - Allergology

    Gwangju 1841811, 61469
    South Korea

    Site Not Available

  • Inha University Hospital

    Incheon 1843564, 22332
    South Korea

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si 1897000, 13620
    South Korea

    Site Not Available

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul 1835848, 07441
    South Korea

    Site Not Available

  • Korea University Guro Hospital

    Seoul 1835848, 08308
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Ajou University Hospital

    Suwon 1835553, 16499
    South Korea

    Site Not Available

  • Yonsei University, Wonju Severance Christian Hospital

    Wŏnju 1833105,
    South Korea

    Site Not Available

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 813 404
    Taiwan

    Site Not Available

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City 1673820, 807
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung City 1673820, 813 404
    Taiwan

    Site Not Available

  • Kuang Tien General Hospital - Dajia

    Taichung, 437
    Taiwan

    Site Not Available

  • Kuang Tien General Hospital - Dajia

    Taichung 1668399, 437
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan 1668355, 704
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan City 1668355, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Taipei Medical University - Taipei Medical University Hospital

    Taipei, 110
    Taiwan

    Site Not Available

  • Tri-Service General Hospital - Neihu Branch - Infectious Diseases

    Taipei, 114
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 100
    Taiwan

    Site Not Available

  • Taipei Medical University - Taipei Medical University Hospital

    Taipei 1668341, 110
    Taiwan

    Site Not Available

  • Tri-Service General Hospital - Neihu Branch - Infectious Diseases

    Taipei 1668341, 114
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

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