A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
NCT ID: NCT06864143
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1320 participants
INTERVENTIONAL
2025-03-07
2025-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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mRNA-1083 Composition 1 Dose A Lot A
Participants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1.
mRNA-1083 Composition 1 Dose A Lot A
Sterile liquid for injection
mRNA-1083 Composition 1 Dose A Lot B
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1.
mRNA-1083 Composition 1 Dose A Lot B
Sterile liquid for injection
mRNA-1083 Composition 1 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.
mRNA-1083 Composition 1 Dose B
Sterile liquid for injection
mRNA-1083 Composition 1 Dose C
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.
mRNA-1083 Composition 1 Dose C
Sterile liquid for injection
mRNA-1083 Composition 2 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.
mRNA-1083 Composition 2 Dose A
Sterile liquid for injection
mRNA-1083 Composition 2 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.
mRNA-1083 Composition 2 Dose B
Sterile liquid for injection
mRNA-1083 Composition 3 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1.
mRNA-1083 Composition 3 Dose A
Sterile liquid for injection
mRNA-1083 Composition 3 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1.
mRNA-1083 Composition 3 Dose B
Sterile liquid for injection
Influenza Vaccine
Participants will receive single IM injection of Influenza Vaccine on Day 1.
Influenza Vaccine
Sterile liquid for injection
COVID-19 Vaccine
Participants will receive single IM injection of COVID-19 Vaccine on Day 1.
COVID-19 Vaccine
Sterile liquid for injection
Investigational Influenza Vaccine
Participants will receive single IM injection of Investigational Influenza Vaccine on Day 1.
Investigational Influenza Vaccine
Sterile liquid for injection
Investigational COVID-19 Vaccine Lot A
Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1.
Investigational COVID-19 Vaccine Lot A
Sterile liquid for injection
Investigational COVID-19 Vaccine Lot B
Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1.
Investigational COVID-19 Vaccine Lot B
Sterile liquid for injection
Interventions
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mRNA-1083 Composition 1 Dose A Lot A
Sterile liquid for injection
mRNA-1083 Composition 1 Dose A Lot B
Sterile liquid for injection
mRNA-1083 Composition 1 Dose B
Sterile liquid for injection
mRNA-1083 Composition 1 Dose C
Sterile liquid for injection
mRNA-1083 Composition 2 Dose A
Sterile liquid for injection
mRNA-1083 Composition 2 Dose B
Sterile liquid for injection
mRNA-1083 Composition 3 Dose A
Sterile liquid for injection
mRNA-1083 Composition 3 Dose B
Sterile liquid for injection
Influenza Vaccine
Sterile liquid for injection
COVID-19 Vaccine
Sterile liquid for injection
Investigational Influenza Vaccine
Sterile liquid for injection
Investigational COVID-19 Vaccine Lot A
Sterile liquid for injection
Investigational COVID-19 Vaccine Lot B
Sterile liquid for injection
Eligibility Criteria
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Inclusion Criteria
* Participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to Day 1 and for at least 90 days after the study intervention administration.
* Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with the last COVID-19 vaccine administered \>150 days prior to Day 1.
Exclusion Criteria
* Tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.
* History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 150 days prior to Day 1.
* Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, 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 within 28 days prior to Day 1 or plans to do so within 28 days post study injection.
* Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
* Received a licensed/authorized COVID-19 vaccine within 150 days prior to Day 1.
* Received any investigational influenza vaccine, investigational COVID-19 vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1.
* Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline).
18 Years
64 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Headlands Research Scottsdale
Scottsdale, Arizona, United States
Artemis Research (Headlands)
San Diego, California, United States
Clinical Research Atlanta (Headlands)
Stockbridge, Georgia, United States
Velocity Clinical Research, Boise
Meridian, Idaho, United States
DM Clinical Research - Chicago
Melrose Park, Illinois, United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, United States
DM Clinical Research - Boston
Brookline, Massachusetts, United States
DM Clinical Research - Detroit
Southfield, Michigan, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, United States
Velocity Clinical Research, Cincinnati, Springdale
Cincinnati, Ohio, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
Trial Management Associates, LLC
Myrtle Beach, South Carolina, United States
DM Clinical Research - Bellaire
Houston, Texas, United States
DM Clinical Research - Tomball
Tomball, Texas, United States
Countries
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Other Identifiers
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mRNA-1083-P202
Identifier Type: -
Identifier Source: org_study_id
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