A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine)

October 9, 2025 updated by: ModernaTX, Inc.

A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity in Relation to the Product Attributes of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Adults ≥50 to <65 Years of Age

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to <65 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be comprised of 2 parts, Parts 1 and 2. In Part 1, participants will be randomized into 4 study groups (Lots A, B, C, and D). Upon completion of Part 1, participants will be randomized into 2 study groups (Lots A and E) in Part 2.

Study Type

Interventional

Enrollment (Actual)

932

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4T3
        • Diex Recherche Quebec Inc.
    • Ontario
      • Toronto, Ontario, Canada, M4G 3E8
        • Centricity Research
      • Toronto, Ontario, Canada, M9W 4L6
        • Centricity Research
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R4S3
        • Centricity Research
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • DIEX Recherche Sherbrooke Inc.
  • United States
    • Florida
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc.
      • Hollywood, Florida, United States, 33024
        • Cenexel RCA
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC dba Flourish Research
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Cenexel IRA
    • Illinois
      • River Forest, Illinois, United States, 60305
        • DM Clinical Research - River Forest
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • JCCT
    • New Jersey
      • Marlton, New Jersey, United States, 80530
        • Hassman Research Institute - Berlin - CenExel - PPDS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • DM Clinical Research - Philadelphia
    • Texas
      • Houston, Texas, United States, 77065-5685
        • DM Clinical Research - Cyfair Clinical Research Center - PPDS
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, LLC dba Flourish Research
      • Sugar Land, Texas, United States, 77478
        • DM Clinical Research - Sugarland
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - Tomball MDC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Investigator assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
  2. Participants of nonchildbearing potential may be enrolled in the study.
  3. Participants who could become pregnant: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy.
  4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
  5. Have received an influenza vaccine in the previous season (since September 2023 for Part 1, since Sep 2024 for Part 2).

Exclusion Criteria:

  1. Reported diagnosis or condition that is associated with increased risk of severe influenza disease or complications, including individuals with chronic medical conditions.
  2. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
  3. History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
  4. Received corticosteroids at ≥10 milligrams (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.
  5. Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (e.g., infliximab), within 180 days prior to Day 1 or plans to do so during the study.
  6. Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection.
  7. Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
  8. Received a licensed/authorized SARS-CoV-2 vaccine within 90 days prior to Day 1.
  9. Received any investigational influenza vaccine, investigational coronavirus disease 2019 (COVID-19) vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1. Participants from mRNA-1083-P201 Part 1 will also be excluded from Part 2.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Group 1: mRNA-1083 Lot A
Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 1.
Biological: mRNA-1083
IM injection in a deltoid muscle.
Experimental: Part 1 Group 2: mRNA-1083 Lot B
Participants will receive mRNA-1083 Lot B as a single injection on Day 1 in Part 1.
Biological: mRNA-1083
IM injection in a deltoid muscle.
Experimental: Part 1 Group 3: mRNA-1083 Lot C
Participants will receive mRNA-1083 Lot C as a single injection on Day 1 in Part 1.
Biological: mRNA-1083
IM injection in a deltoid muscle.
Experimental: Part 1 Group 4: mRNA-1083 Lot D
Participants will receive mRNA-1083 Lot D as a single injection on Day 1 in Part 1.
Biological: mRNA-1083
IM injection in a deltoid muscle.
Experimental: Part 2 Group 5: mRNA-1083 Lot A
Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 2.
Biological: mRNA-1083
IM injection in a deltoid muscle.
Experimental: Part 2 Group 6: mRNA-1083 Lot E
Participants will receive mRNA-1083 Lot E as a single injection on Day 1 in Part 2.
Biological: mRNA-1083
IM injection in a deltoid muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to Day 181
Up to Day 181
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame: Up to Day 181
Up to Day 181
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 28 (28 days after vaccination)
Up to Day 28 (28 days after vaccination)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Up to Day 7 (7 days after vaccination)
Up to Day 7 (7 days after vaccination)
Geometric Mean Value of Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay for Influenza
Time Frame: Day 29
Day 29
Geometric Mean Value of Antibodies at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) for SARS-CoV-2
Time Frame: Day 29
Day 29
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time Frame: Up to Day 181
Up to Day 181
Number of Participants with AEs Leading to Discontinuation from Study Participation
Time Frame: Up to Day 181
Up to Day 181

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Fold Rise (GMFR) of Antibodies at Day 29 Relative to Day 1, as Measured by HAI Assay for Influenza
Time Frame: Day 1, Day 29
Day 1, Day 29
GMFR of Antibodies at Day 29 Relative to Day 1, as Measured by PsVNA for SARS-CoV-2
Time Frame: Day 1, Day 29
Day 1, Day 29
Seroconversion Rate (SCR) in Anti-hemagglutinin (HA) Antibody Values at Day 29, as Measured by HAI Assay for Influenza
Time Frame: Day 29
Day 29
Seroresponse Rate (SRR) in Neutralizing Antibody (nAb) Values at Day 29, as Measured by PsVNA for SARS-CoV-2
Time Frame: Day 29
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Actual)

September 25, 2025

Study Completion (Actual)

September 25, 2025

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 9, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1083-P201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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