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

NCT ID: NCT06694389

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2457 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2025-11-17

Brief 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).

Conditions

COVID-19; Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

mRNA-1083 and Placebo

Participants 50 years of age and older will receive mRNA-1083 by intramuscular (IM) injection and placebo by subcutaneous (SC) or IM injection administered on Day 1.

Group Type: EXPERIMENTAL

mRNA-1083

Intervention Type: BIOLOGICAL

Suspension for injection

Placebo

Intervention Type: OTHER

0.9% sodium chloride suspension for injection

Licensed influenza vaccine + SARS-CoV-2 vaccine

Participants of age 50 years and older will receive licensed influenza vaccine by SC or IM injection and SARS-CoV-2 vaccine by IM injection administered on Day 1.

Group Type: ACTIVE_COMPARATOR

Licensed Influenza Vaccine

Intervention Type: BIOLOGICAL

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

SARS-CoV-2 Vaccine

Intervention Type: BIOLOGICAL

Suspension for injection

Interventions

mRNA-1083

Suspension for injection

Intervention Type: BIOLOGICAL

Placebo

0.9% sodium chloride suspension for injection

Intervention Type: OTHER

Licensed Influenza Vaccine

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

Intervention Type: BIOLOGICAL

SARS-CoV-2 Vaccine

Suspension for injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Influenza HA, Biken, and; Fluarix tetra; mRNA-1273

Eligibility Criteria

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

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Public Health Association.Inc.

Nagoya, Aichi-ken, Japan

Daido Clinic

Nagoya, Aichi-ken, Japan

Tenjin Sogo Clinic

Fukuoka, Fukuoka, Japan

PS Clinic - Internal medicine

Fukuoka, Fukuoka, Japan

Fukuoka Heartnet Hospital

Fukuoka, Fukuoka, Japan

Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical

Sapporo, Hokkaido, Japan

Motomachi Takatsuka Naika Clinic - Internal Medicine

Yokohama, Kanagawa, Japan

Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic

Kumamoto, Kumamoto, Japan

Nishi-Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Sato Hospital

Osaki-shi, Miyagi, Japan

Yokoi Medicine Clinic

Mino, Osaka, Japan

Shinwakai Adachi Kyosai Hospital - Internal Medicine

Adachi-ku, Tokyo, Japan

Dojinkinenkai Meiwa Hospital

Chiyoda-ku, Tokyo, Japan

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, Japan

Tokyo center clinic - Internal medicine

Chuo-ku, Tokyo, Japan

Medical Corporation Asbo Tokyo Asbo Clinic

Chuo-ku, Tokyo, Japan

New Medical Research System Clinic

Hachioji-shi, Tokyo, Japan

Shimamura Memorial Hospital

Nerima City, Tokyo, Japan

Denenchofu Family Clinic

Ōta-ku, Tokyo, Japan

Hillside Clinic Jingumae

Shibuya-ku, Tokyo, Japan

Clinical Research Tokyo Hospital - Clinical Research Center

Shinjuku, Tokyo, Japan

Higashi-Shinjuku Clinic - Internal Medicine

Shinjuku, Tokyo, Japan

Shinei Medical Healthcare Clinic

Suginami, Tokyo, Japan

Souseikai Sumida Hospital

Sumida-Ku, Tokyo, Japan

Seishukai Clinic

Taito-ku, Tokyo, Japan

Metropolitan Clinic - Internal Medicine

Toshima-ku, Tokyo, Japan

Korea University Ansan Hospital

Ansan-si, , South Korea

Kyungpook National University Hospital - Infectious Diseases

Daegu, , South Korea

Chonnam National University Hospital - Allergology

Gwangju, , South Korea

Inha University Hospital

Incheon, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, , South Korea

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Kuang Tien General Hospital - Dajia

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Medical University - Taipei Medical University Hospital

Taipei, , Taiwan

Tri-Service General Hospital - Neihu Branch - Infectious Diseases

Taipei, , Taiwan

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Japan; South Korea; Taiwan

Other Identifiers

mRNA-1083-P302

Identifier Type: -

Identifier Source: org_study_id