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COVID-19Phase 3NCT06694389

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

A Phase 3 study testing mRNA-1083, Licensed Influenza Vaccine and SARS-CoV-2 Vaccine in people with COVID-19 and Influenza, run by ModernaTX, Inc. at 44 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, Influenza
What is being tested?
mRNA-1083, Licensed Influenza Vaccine and SARS-CoV-2 Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,457 participants
Where
44 sitesin 3 countries
Study dates
18 Nov 2024to 17 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

44 sites in 3 countries.

44 sites in 3 countries

Japan26 sites

  • Shinwakai Adachi Kyosai Hospital - Internal Medicine

    Adachi-ku, Tokyo, 120-0022

  • Dojinkinenkai Meiwa Hospital

    Chiyoda-ku, Tokyo, 101-0041

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo, 103-0025

  • Tokyo center clinic - Internal medicine

    Chuo-ku, Tokyo, 103-0027

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Chuo-ku, Tokyo, 104-0031

  • Tenjin Sogo Clinic

    Fukuoka, Fukuoka, 810-0021

  • PS Clinic - Internal medicine

    Fukuoka, Fukuoka, 812-0025

  • Fukuoka Heartnet Hospital

    Fukuoka, Fukuoka, 819-0002

  • New Medical Research System Clinic

    Hachioji-shi, Tokyo, 192-0046

  • Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic

    Kumamoto, Kumamoto, 860-0833

  • Nishi-Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4157

  • Yokoi Medicine Clinic

    Mino, Osaka, 562-0003

  • Public Health Association.Inc.

    Nagoya, Aichi-ken, 453-0804

  • Daido Clinic

    Nagoya, Aichi-ken, 457-8511

  • Shimamura Memorial Hospital

    Nerima City, Tokyo, 177-0051

  • Sato Hospital

    Osaki-shi, Miyagi, 989-6143

  • Denenchofu Family Clinic

    Ōta-ku, Tokyo, 145-0071

  • Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical

    Sapporo, Hokkaido, 060-0011

  • Hillside Clinic Jingumae

    Shibuya-ku, Tokyo, 150-0001

  • Clinical Research Tokyo Hospital - Clinical Research Center

    Shinjuku, Tokyo, 160-0004

  • Higashi-Shinjuku Clinic - Internal Medicine

    Shinjuku, Tokyo, 169-0072

  • Shinei Medical Healthcare Clinic

    Suginami, Tokyo, 166-0003

  • Souseikai Sumida Hospital

    Sumida-Ku, Tokyo, 130-0004

  • Seishukai Clinic

    Taito-ku, Tokyo, 111-0036

  • Metropolitan Clinic - Internal Medicine

    Toshima-ku, Tokyo, 171-0021

  • Motomachi Takatsuka Naika Clinic - Internal Medicine

    Yokohama, Kanagawa, 231-0023

Other trials in Japan

South Korea10 sites

  • Korea University Ansan Hospital

    Ansan-si, 15355

  • Kyungpook National University Hospital - Infectious Diseases

    Daegu

  • Chonnam National University Hospital - Allergology

    Gwangju, 61469

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

  • Korea University Guro Hospital

    Seoul, 08308

  • Ajou University Hospital

    Suwon, 16499

  • Yonsei University, Wonju Severance Christian Hospital

    Wŏnju

Other trials in South Korea

Taiwan8 sites

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813 404

  • Kuang Tien General Hospital - Dajia

    Taichung, 437

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Medical University - Taipei Medical University Hospital

    Taipei, 110

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

    Taipei, 114

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official 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

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
Being tested
mRNA-1083, Placebo, Licensed Influenza Vaccine, SARS-CoV-2 Vaccine
Keywords
Influenza, COVID-19, Messenger RNA, Moderna
Medical subject headings
COVID-19, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1083Biological

    Suspension for injection

  • PlaceboOther

    0.9% sodium chloride suspension for injection

  • Licensed Influenza VaccineBiological

    Also called Influenza HA, Biken, and, Fluarix tetra

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

  • SARS-CoV-2 VaccineBiological

    Also called mRNA-1273

    Suspension for injection

Study groups in NCT06694389
Study groupRoleWhat they receive
mRNA-1083 and PlaceboExperimentalParticipants 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.
Receives: Biological: mRNA-1083; Other: Placebo
Licensed influenza vaccine + SARS-CoV-2 vaccineActive comparatorParticipants 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.
Receives: Biological: Licensed Influenza Vaccine; Biological: SARS-CoV-2 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 29

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

    Measured: Day 29

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

    Measured: Day 1 through 7 days after study injection

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

    Measured: Day 1 through 28 days after study injection

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

    Measured: Day 1 though Day 181

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

    Measured: Day 1 though Day 181

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

    Measured: Day 1 through Day 181

  8. Number of Participants With AEs Leading to Discontinuation

    Measured: Day 1 through Day 181

Secondary outcomes (4)

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

    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.

    Measured: Day 29

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

    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.

    Measured: Day 29

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

    Measured: Day 1, Day 29

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

    Measured: Day 1, Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start18 Nov 2024
  3. Primary completion17 Nov 2025
  4. Study completion17 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,457 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06694389
Sponsor's protocol ID
mRNA-1083-P302
Status last verified
Nov 2025
First submitted
15 Nov 2024
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kostanyan L, Fukase H, Rumyantsev A, Hashizume K, Osibajo S, Kogawara O. Immunogenicity, reactogenicity, and safety of an mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine, mRNA-1083, in adults aged >/=50 years in Japan. Vaccine. 2026 Jul 30;88:128961. doi: 10.1016/j.vaccine.2026.128961. Online ahead of print.

    PubMed 42531981

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mRNA-1083, Licensed Influenza Vaccine and SARS-CoV-2 Vaccine in people with COVID-19 and Influenza, run by ModernaTX, Inc. at 44 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay (time frame: Day 29). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06694389, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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