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

NCT06694389 | Completed Phase 3 FDA Drug

• 1 other identifier: mRNA-1083-P302
• Study Type: interventional
• Target: 2,457
• Locations: 3 countries
• Sites: 44

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

Keywords

Influenza; COVID-19; Messenger RNA; Moderna

Outcome Measures

Primary Outcomes (8)

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

  Day 29

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

  Day 29

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

  Day 1 through 7 days after study injection

• Number of Participants With Unsolicited Adverse Events (AEs)

  Day 1 through 28 days after study injection

• Number of Participants With Medically Attended Adverse Events (MAAEs)

  Day 1 though Day 181

• Number of Participants With Adverse Events of Special Interest (AESIs)

  Day 1 though Day 181

• Number of Participants With Serious Adverse Events (SAEs)

  Day 1 through Day 181

• Number of Participants With AEs Leading to Discontinuation

  Day 1 through Day 181

Secondary Outcomes (4)

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

  Day 29

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

  Day 29

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

  Day 1, Day 29

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

  Day 1, Day 29

Study Arms (2)

mRNA-1083 and Placebo

EXPERIMENTAL

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.

Biological: mRNA-1083; Other: Placebo

Licensed influenza vaccine + SARS-CoV-2 vaccine

ACTIVE COMPARATOR

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.

Biological: Licensed Influenza Vaccine; Biological: SARS-CoV-2 Vaccine

Interventions

mRNA-1083 BIOLOGICAL

Suspension for injection

mRNA-1083 and Placebo

Placebo OTHER

0.9% sodium chloride suspension for injection

mRNA-1083 and Placebo

Licensed Influenza Vaccine BIOLOGICAL

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

Also known as: Influenza HA, Biken, and, Fluarix tetra

Licensed influenza vaccine + SARS-CoV-2 vaccine

SARS-CoV-2 Vaccine BIOLOGICAL

Suspension for injection

Also known as: mRNA-1273

Licensed influenza vaccine + SARS-CoV-2 vaccine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (44)

Public Health Association.Inc.

Nagoya, Aichi-ken, 453-0804, Japan

Location

Daido Clinic

Nagoya, Aichi-ken, 457-8511, Japan

Location

Tenjin Sogo Clinic

Fukuoka, Fukuoka, 810-0021, Japan

Location

PS Clinic - Internal medicine

Fukuoka, Fukuoka, 812-0025, Japan

Location

Fukuoka Heartnet Hospital

Fukuoka, Fukuoka, 819-0002, Japan

Location

Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical

Sapporo, Hokkaido, 060-0011, Japan

Location

Motomachi Takatsuka Naika Clinic - Internal Medicine

Yokohama, Kanagawa, 231-0023, Japan

Location

Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic

Kumamoto, Kumamoto, 860-0833, Japan

Location

Nishi-Kumamoto Hospital

Kumamoto, Kumamoto, 861-4157, Japan

Location

Sato Hospital

Osaki-shi, Miyagi, 989-6143, Japan

Location

Yokoi Medicine Clinic

Mino, Osaka, 562-0003, Japan

Location

Shinwakai Adachi Kyosai Hospital - Internal Medicine

Adachi-ku, Tokyo, 120-0022, Japan

Location

Dojinkinenkai Meiwa Hospital

Chiyoda-ku, Tokyo, 101-0041, Japan

Location

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, 103-0025, Japan

Location

Tokyo center clinic - Internal medicine

Chuo-ku, Tokyo, 103-0027, Japan

Location

Medical Corporation Asbo Tokyo Asbo Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

New Medical Research System Clinic

Hachioji-shi, Tokyo, 192-0046, Japan

Location

Shimamura Memorial Hospital

Nerima City, Tokyo, 177-0051, Japan

Location

Denenchofu Family Clinic

Ōta-ku, Tokyo, 145-0071, Japan

Location

Hillside Clinic Jingumae

Shibuya-ku, Tokyo, 150-0001, Japan

Location

Clinical Research Tokyo Hospital - Clinical Research Center

Shinjuku, Tokyo, 160-0004, Japan

Location

Higashi-Shinjuku Clinic - Internal Medicine

Shinjuku, Tokyo, 169-0072, Japan

Location

Shinei Medical Healthcare Clinic

Suginami, Tokyo, 166-0003, Japan

Location

Souseikai Sumida Hospital

Sumida-Ku, Tokyo, 130-0004, Japan

Location

Seishukai Clinic

Taito-ku, Tokyo, 111-0036, Japan

Location

Metropolitan Clinic - Internal Medicine

Toshima-ku, Tokyo, 171-0021, Japan

Location

Korea University Ansan Hospital

Ansan-si, 15355, South Korea

Location

Kyungpook National University Hospital - Infectious Diseases

Daegu, South Korea

Location

Chonnam National University Hospital - Allergology

Gwangju, 61469, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813 404, Taiwan

Location

Kuang Tien General Hospital - Dajia

Taichung, 437, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Medical University - Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Tri-Service General Hospital - Neihu Branch - Infectious Diseases

Taipei, 114, Taiwan

Location

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

COVID-19; Influenza, Human

Interventions

COVID-19 Vaccines; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: November 18, 2024
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

TW (8); KR (10); JP (26)