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: March 14, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Influenza

Covid-19

Treatment

SARS-CoV-2 Vaccine

Placebo

Licensed Influenza Vaccine

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: 2450
Treatment Group(s): 4
Primary Treatment: SARS-CoV-2 Vaccine
Phase: 3
Study Start date:
November 18, 2024
Estimated Completion Date:
December 10, 2025

Connect with a study center

  • Daido Clinic

    Nagoya-shi, Aichi 457-8511
    Japan

    Active - Recruiting

  • Public Health Association.Inc.

    Nagoya-shi, Aichi 453-0804
    Japan

    Active - Recruiting

  • Fukuoka Heartnet Hospital

    Fukuoka-shi, Fukuoka 819-0002
    Japan

    Active - Recruiting

  • PS Clinic - Internal medicine

    Fukuoka-shi, Fukuoka 812-0025
    Japan

    Active - Recruiting

  • Tenjin Sogo Clinic

    Fukuoka-shi, Fukuoka 810-0021
    Japan

    Active - Recruiting

  • Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical

    Sapporo-shi, Hokkaido 060-0011
    Japan

    Active - Recruiting

  • Motomachi Takatsuka Naika Clinic - Internal Medicine

    Yokohama-shi, Kanagawa 231-0023
    Japan

    Active - Recruiting

  • Nishi-Kumamoto Hospital

    Kumamoto-shi, Kumamoto 861-4157
    Japan

    Active - Recruiting

  • Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic

    Kumamoto-shi, Kumamoto 860-0833
    Japan

    Active - Recruiting

  • Sato Hospital

    Osaki-shi, Miyagi 989-6143
    Japan

    Active - Recruiting

  • Yokoi Medicine Clinic

    Mino, Osaka 562-0003
    Japan

    Active - Recruiting

  • Shinwakai Adachi Kyosai Hospital - Internal Medicine

    Adachi-ku, Tokyo 120-0022
    Japan

    Active - Recruiting

  • Dojinkinenkai Meiwa Hospital

    Chiyoda-ku, Tokyo 101-0041
    Japan

    Active - Recruiting

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

    Active - Recruiting

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo 103-0025
    Japan

    Active - Recruiting

  • Tokyo center clinic - Internal medicine

    Chuo-ku, Tokyo 103-0027
    Japan

    Active - Recruiting

  • New Medical Research System Clinic

    Hachioji-shi, Tokyo 192-0046
    Japan

    Active - Recruiting

  • Shimamura Memorial Hospital

    Nerima, Tokyo 177-0051
    Japan

    Active - Recruiting

  • Denenchofu Family Clinic

    Ota-ku, Tokyo 145-0071
    Japan

    Active - Recruiting

  • Hillside Clinic Jingumae

    Shibuya-ku, Tokyo 150-0001
    Japan

    Active - Recruiting

  • Clinical Research Tokyo Hospital - Clinical Research Center

    Shinjuku, Tokyo 160-0004
    Japan

    Active - Recruiting

  • Higashi-Shinjuku Clinic - Internal Medicine

    Shinjuku, Tokyo 169-0072
    Japan

    Active - Recruiting

  • Shinei Medical Healthcare Clinic

    Suginami, Tokyo 166-0003
    Japan

    Active - Recruiting

  • Souseikai Sumida Hospital

    Sumida-Ku, Tokyo 130-0004
    Japan

    Active - Recruiting

  • Seishukai Clinic

    Taito-ku, Tokyo 111-0036
    Japan

    Active - Recruiting

  • Metropolitan Clinic - Internal Medicine

    Toshima-ku, Tokyo 171-0021
    Japan

    Active - Recruiting

  • 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

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 813 404
    Taiwan

    Site Not Available

  • Kuang Tien General Hospital - Dajia

    Taichung, 437
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 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

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

    Taoyuan, 333
    Taiwan

    Site Not Available

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