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Clinical Trials List

Protocol NumbermRNA-1083-P302
NCT Number(ClinicalTrials.gov Identfier)NCT06694389
Completed

2024-12-01 - 2025-11-30

Phase III

Recruiting8

ICD-10J17

Pneumonia in diseases classified elsewhere

ICD-9484.8

Pneumonia in other infectious diseases classified elsewhere

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

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/22

Investigators and Locations

Principal Investigator Cheng-Hsun Chiu Division of Pediatrics
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Liang Lu Division of Infectious Disease
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator MING-CHE LIU 無
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wang-Huei Sheng 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳俊志 Division of Infectious Disease
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 邱俊翔 無
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳垚生 無
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ching Yang
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

COVID-19、Influenza

Objectives

The purpose of the trial was to evaluate the immunogenicity, reactivity, and safety of mRNA-1083 in adults with ≥ 50 YOA from participating countries (Japan, Taiwan, and South Korea).

Test Drug

Suspension Injection

Active Ingredient

mRNA-1083

Dosage Form

275

Dosage

NA

Endpoints

• Geometric mean (GM) concentration of influenza antibodies as measured by hemagglutination inhibition assay (HAI) on day 29

• Geometric mean (GM) concentration of SARS-CoV-2 antibodies as measured by pseudovirus neutralization assay (PsVNA) on day 29

• Number of participants experiencing solicited local and systemic adverse reactions (ARs) from day 1 to day 7 post-injection

• Number of participants experiencing unsoliciting adverse events (AEs) from day 1 to day 28 post-injection

• Number of participants experiencing medically necessary adverse events (MAAEs) from day 1 to day 181

• Number of participants experiencing adverse events of particular concern (AESIs) from day 1 to day 181

• Number of participants experiencing serious adverse events (SAEs) from day 1 to day 181

• Number of participants discontinuing the trial due to adverse events from day 1 to day 181

Inclution Criteria

Key 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

Key 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.

The Estimated Number of Participants

  • Taiwan

    150 participants

  • Global

    2450 participants

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