A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
NCT ID: NCT05827926
Last Updated: 2024-12-27
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
PHASE1/PHASE2
1763 participants
INTERVENTIONAL
2023-04-14
2024-12-03
Brief Summary
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The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \<50 years of age.
Detailed Description
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Part 2: Approximately, 520 participants between ≥18 to \<50 years of age will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since Sept 2023).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Part 1 Cohort A2: mRNA-1083.1 Dose B
Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.
mRNA-1083.1
Sterile liquid for injection
Part 1 Cohort A3: mRNA-1083.1 Dose C
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
mRNA-1083.1
Sterile liquid for injection
Part 1 Cohort A4: mRNA-1083.2 Dose A
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
mRNA-1083.2
Sterile liquid for injection
Part 1 Cohort A5: mRNA-1083.2 Dose B
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
mRNA-1083.2
Sterile liquid for injection
Part 1 Cohort A6: mRNA-1083.2 Dose C
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
mRNA-1083.2
Sterile liquid for injection
Part 1 Cohort A7: mRNA-1083.3
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
mRNA-1083.3
Sterile liquid for injection
Part 1 Cohort A8: Investigational Influenza Vaccine 1
Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.
Investigational Influenza Vaccine 1
Sterile liquid for injection
Part 1 Cohort A9: Investigational COVID-19 Vaccine 1
Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
Investigational COVID-19 Vaccine 1
Sterile liquid for injection
Part 1 Cohort A10: COVID-19 Vaccine 1
Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.
COVID-19 Vaccine 1
Sterile liquid for injection
Part 1 Cohort A11: Investigational Influenza Vaccine 2
Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.
Investigational Influenza Vaccine 2
Sterile liquid for injection
Part 1 Cohort A12: Influenza Vaccine 1
Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.
Influenza Vaccine 1
quadrivalent seasonal influenza vaccine
Part 1 Cohort A13: Influenza Vaccine 2
Participants will receive single IM injection of Influenza Vaccine 2 on Day 1.
Influenza Vaccine 2
quadrivalent seasonal influenza vaccine
Part 1 Cohort B1: mRNA-1083.1 Dose A
Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.
mRNA-1083.1
Sterile liquid for injection
Part 1 Cohort B2: mRNA-1083.1 Dose B
Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.
mRNA-1083.1
Sterile liquid for injection
Part 1 Cohort B3: mRNA-1083.1 Dose C
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
mRNA-1083.1
Sterile liquid for injection
Part 1 Cohort B4: mRNA-1083.2 Dose A
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
mRNA-1083.2
Sterile liquid for injection
Part 1 Cohort B5: mRNA-1083.2 Dose B
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
mRNA-1083.2
Sterile liquid for injection
Part 1 Cohort B6: mRNA-1083.2 Dose C
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
mRNA-1083.2
Sterile liquid for injection
Part 1 Cohort B7: mRNA-1083.3
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
mRNA-1083.3
Sterile liquid for injection
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.
Investigational Influenza Vaccine 1
Sterile liquid for injection
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
Investigational COVID-19 Vaccine 1
Sterile liquid for injection
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.
COVID-19 Vaccine 1
Sterile liquid for injection
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.
Investigational Influenza Vaccine 2
Sterile liquid for injection
Part 1 Cohort B12: Influenza Vaccine 1
Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.
Influenza Vaccine 1
quadrivalent seasonal influenza vaccine
Part 2: mRNA-1083 Composition 1 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A on Day 1.
mRNA-1083
Sterile liquid for injection
Part 2: 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
Sterile liquid for injection
Part 2: 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
Sterile liquid for injection
Part 2: 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
Sterile liquid for injection
Part 2: 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
Sterile liquid for injection
Part 2: mRNA-1083 Composition 2 Dose C
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level C on Day 1.
mRNA-1083
Sterile liquid for injection
Part 2: mRNA-1083 Composition 1 Dose D
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level D on Day 1.
mRNA-1083
Sterile liquid for injection
Part 2: mRNA-1083 Composition 2 Dose D
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level D on Day 1.
mRNA-1083
Sterile liquid for injection
Part 2: Investigational Influenza Vaccine 1 Dose A
Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level A on Day 1.
Investigational Influenza Vaccine 1
Sterile liquid for injection
Part 2: Investigational Influenza Vaccine 1 Dose B
Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level B on Day 1.
Investigational Influenza Vaccine 1
Sterile liquid for injection
Part 2: Investigational COVID-19 Vaccine 2
Participants will receive single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
Investigational COVID-19 Vaccine 2
Sterile liquid for injection
Part 2: COVID-19 Vaccine 2
Participants will receive single IM injection of COVID-19 Vaccine 2 on Day 1.
COVID-19 Vaccine 2
Sterile liquid for injection
Part 2: Influenza Vaccine 1
Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.
Influenza Vaccine 1
quadrivalent seasonal influenza vaccine
Interventions
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Influenza Vaccine 1
quadrivalent seasonal influenza vaccine
mRNA-1083.1
Sterile liquid for injection
mRNA-1083.2
Sterile liquid for injection
mRNA-1083.3
Sterile liquid for injection
Investigational Influenza Vaccine 1
Sterile liquid for injection
Investigational COVID-19 Vaccine 1
Sterile liquid for injection
COVID-19 Vaccine 1
Sterile liquid for injection
Investigational Influenza Vaccine 2
Sterile liquid for injection
Influenza Vaccine 2
quadrivalent seasonal influenza vaccine
mRNA-1083
Sterile liquid for injection
Investigational COVID-19 Vaccine 2
Sterile liquid for injection
COVID-19 Vaccine 2
Sterile liquid for injection
Eligibility Criteria
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Inclusion Criteria
* Adults ≥18 to \<80 years of age at the time of consent.
* Body mass index (BMI) of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit.
* Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
* Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥120 days prior to Day 1.
Part 2 (Phase 2 Extension)
* Adults ≥18 to \<50 years of age at the time of consent.
* BMI of 18 kg/m\^2 to 35 kg/m\^2 (inclusive) at the Screening Visit.
* Healthy as determined by medical evaluation, including medical history, and physical examination.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
* Have received at least 2 doses of locally authorized or approved COVID-19 vaccines and last dose was ≥90 days prior to Day 1.
Exclusion Criteria
* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* 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 clinical trial or could interfere with the interpretation of study results.
* Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration.
* Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1.
* Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
* Participant 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.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the clinical trial.
* Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home.
Part 2 (Phase 2 Extension) Only
* Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study.
18 Years
79 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Chandler Clinical Trials
Chandler, Arizona, United States
Benchmark Research
Colton, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Central Valley Research
Modesto, California, United States
Benchmark Research
Sacramento, California, United States
Tekton Research
Longmont, Colorado, United States
Accel Research Sites
DeLand, Florida, United States
CenExel
Hollywood, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States
Accel Research Sites
Maitland, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Centricity Research
Columbus, Georgia, United States
Accel Research Site
Decatur, Georgia, United States
CenExel iResearch
Decatur, Georgia, United States
Lifeline Primary Care
Lilburn, Georgia, United States
Koch Family Medicine
Morton, Illinois, United States
Optimal Research
Peoria, Illinois, United States
DM Clinical Research
River Forest, Illinois, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Tekton Research
Wichita, Kansas, United States
Versailles Family Medicine
Versailles, Kentucky, United States
Velocity Clinical research
Baton Rouge, Louisiana, United States
Benchmark Research
Metairie, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
DelRicht Research
Prairieville, Louisiana, United States
Annapolis Internal Medicine
Annapolis, Maryland, United States
Velocity Clinical Research
Rockville, Maryland, United States
DM Clinical Research
Brookline, Massachusetts, United States
Vida Clinical Studies
Dearborn Heights, Michigan, United States
DelRicht Research
Gulfport, Mississippi, United States
Clay Platte Family Medicine
Kansas City, Missouri, United States
Velocity Clinical Research
Lincoln, Nebraska, United States
Velocity Clinical Research
Norfolk, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
CCT Research
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Rochester Clinical Research
Rochester, New York, United States
Tryon Medical Partners
Charlotte, North Carolina, United States
Trial Management Associates
Wilmington, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Centricity Research
Columbus, Ohio, United States
WellNow Urgent Care & Research
Dayton, Ohio, United States
Lynn Institute of East Oklahoma
Oklahoma City, Oklahoma, United States
DelRicht Research
Tulsa, Oklahoma, United States
Tekton Research Inc
Yukon, Oklahoma, United States
DM Clinical Research
Philadelphia, Pennsylvania, United States
Mercado Medical Practice
Philadelphia, Pennsylvania, United States
DelRicht Research
Charleston, South Carolina, United States
Trial Management Associates
Myrtle Beach, South Carolina, United States
Medical Care
Elizabethton, Tennessee, United States
DelRicht Research
Hendersonville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Tekton Research
Austin, Texas, United States
Tekton Research
Beaumont, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Cyfair Clinical Research
Houston, Texas, United States
Texas Center for Drug Development
Houston, Texas, United States
DelRicht Research
McKinney, Texas, United States
Benchmark Research
San Angelo, Texas, United States
Tekton Research
San Antonio, Texas, United States
CCT Research
Pleasant View, Utah, United States
Ogden Clinic
Roy, Utah, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Meridian Clinical Research
Hampton, Virginia, United States
Velocity Clinical Research
Portsmouth, Virginia, United States
Wenatchee Valley Hospital & Clinics Campus
Wenatchee, Washington, United States
Countries
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References
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Rudman Spergel AK, Ananworanich J, Guo R, Deng W, Carmona L, Schaefers K, Paila YD, Kandinov B, Eger CH, Sinkiewicz M, Shao S, Henry C, Shaw CA. mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial. Nat Med. 2025 May;31(5):1484-1493. doi: 10.1038/s41591-025-03591-0. Epub 2025 Mar 18.
Other Identifiers
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mRNA-1083-P101
Identifier Type: -
Identifier Source: org_study_id