A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
NCT ID: NCT06097273
Last Updated: 2025-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
8061 participants
INTERVENTIONAL
2023-10-19
2024-05-28
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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Cohort A1: mRNA-1083 and Placebo
Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1.
mRNA-1083
Suspension for injection
Placebo
0.9% sodium chloride suspension for injection
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 65 years and older will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.
Influenza Vaccine
Commercially available formulation (Suspension for injection \[pre-filled syringe\])
COVID-19 Vaccine
Commercially available formulation (Suspension for injection)
Cohort B1: mRNA-1083 and Placebo
Participants of age 50 to \<65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1.
mRNA-1083
Suspension for injection
Placebo
0.9% sodium chloride suspension for injection
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 50 to \<65 years will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.
Influenza Vaccine
Commercially available formulation (Suspension for injection \[pre-filled syringe\])
COVID-19 Vaccine
Commercially available formulation (Suspension for injection)
Interventions
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mRNA-1083
Suspension for injection
Placebo
0.9% sodium chloride suspension for injection
Influenza Vaccine
Commercially available formulation (Suspension for injection \[pre-filled syringe\])
COVID-19 Vaccine
Commercially available formulation (Suspension for injection)
Eligibility Criteria
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Inclusion Criteria
* 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, and agreement to continue adequate contraception through 3 months following vaccine administration.
* 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 ≥90 days prior to Day 1.
Exclusion Criteria
* 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.
* Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.
* 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.
* Tested positive for influenza by local health authority-approved testing methods ≤150 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 or plans to donate blood products during the study.
50 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Pinnacle Research Group-409 E 10th St
Anniston, Alabama, United States
Accel Research Site - Achieve - Birmingham
Birmingham, Alabama, United States
Cullman Clinical Trials
Cullman, Alabama, United States
Desert Clinical Research - CCT - PPDS
Mesa, Arizona, United States
Foothills Research Center - CCT - PPDS
Phoenix, Arizona, United States
Headlands Research - Scottsdale - PPDS
Scottsdale, Arizona, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Fiel Family & Sports Medicine - PC - CCT - PPDS
Tempe, Arizona, United States
AES - DRS - Synexus Clinical Research US, Inc. - Cerritos
Cerritos, California, United States
Long Beach Research Institute, LLC
Long Beach, California, United States
CenExel Apex (CNS) - Los Alamitos - PPDS
Los Alamitos, California, United States
Central Valley Research, LLC
Modesto, California, United States
Carbon Health- NoHo West Urgent Care and Primary Care
North Hollywood, California, United States
Empire Clinical Research
Pomona, California, United States
Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
Riverside, California, United States
Clinical Innovations Trials - Riverside - CenExel - PPDS
Riverside, California, United States
Peninsula Research Associates - Headlands - PPDS
Rolling Hills Estates, California, United States
Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
San Diego, California, United States
AES - DRS - Synexus Clinical Research US, Inc. - Vista
Vista, California, United States
Tekton Research - Fort Collins - PPDS
Fort Collins, Colorado, United States
Tekton Research - Longmont - PPDS
Longmont, Colorado, United States
Stamford Therapeutics Consortium - ERN - PPDS
Stamford, Connecticut, United States
Chase Medical Research LLC - Waterbury
Waterbury, Connecticut, United States
Revival Research Corporation
Doral, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
CenExel RCA - Hollywood
Hollywood, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States
Health Awareness - Jupiter - ERN - ERN
Jupiter, Florida, United States
Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS
Largo, Florida, United States
Flourish Research - Leesburg - PPDS
Leesburg, Florida, United States
Accel Research Sites - Maitland
Maitland, Florida, United States
AES - DRS - Optimal Research Florida - Melbourne
Melbourne, Florida, United States
Suncoast Research Group LLC - Flourish - PPDS
Miami, Florida, United States
St. Johns Center for Clinical Research - ERN - PPDS
Saint Augustine, Florida, United States
ForCare Clinical Research - CenExel FCR - PPDS
Tampa, Florida, United States
AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
Atlanta, Georgia, United States
DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS
Atlanta, Georgia, United States
iResearch Atlanta - CenExel - PPDS
Decatur, Georgia, United States
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
Fayetteville, Georgia, United States
Georgia Clinic - CCT - PPDS
Norcross, Georgia, United States
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah, Georgia, United States
Clinical Research Atlanta - ERN - PPDS
Stockbridge, Georgia, United States
AES - DRS - Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Flourish Research - Andersonville - PPDS
Chicago, Illinois, United States
Koch Family Medicine
Morton, Illinois, United States
AES - DRS - Optimal Research Illinois - Peoria
Peoria, Illinois, United States
DM Clinical Research - Chicago - ERN - PPDS
River Forest, Illinois, United States
AES - DRS - Synexus Clinical Research US, Inc. - Evansville
Evansville, Indiana, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS
Valparaiso, Indiana, United States
The Iowa Clinic, P.C. - West Des Moines Campus
West Des Moines, Iowa, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Delricht Overland Park
Overland Park, Kansas, United States
Tekton Research - Wichita - PPDS
Wichita, Kansas, United States
DelRicht Research, LLC - Louisville - PPDS
Louisville, Kentucky, United States
Versailles Family Medicine - CCT - PPDS
Versailles, Kentucky, United States
Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS
Baton Rouge, Louisiana, United States
Velocity Clinical Research - Covington - PPDS
Covington, Louisiana, United States
DelRicht Clinical Research, LLC - The Murphy Clinic - PPDS
Mandeville, Louisiana, United States
IMA Clinical Research - Monroe, LA - PPDS
Monroe, Louisiana, United States
DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS
New Orleans, Louisiana, United States
DelRicht Research, LLC - Internal - Baton Rouge - PPDS
Prairieville, Louisiana, United States
Annapolis Internal Medicine - CCT - PPDS
Annapolis, Maryland, United States
Advanced Primary Care & Geriatric Care - CCT - PPDS
Rockville, Maryland, United States
DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS
Rockville, Maryland, United States
Velocity Clinical Research (Rockville - Maryland) - PPDS
Rockville, Maryland, United States
Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS
Silver Spring, Maryland, United States
DM Clinical Research - The Brook House - ERN - PPDS
Brookline, Massachusetts, United States
Headlands Research - Detroit - Headlands - PPDS
Southfield, Michigan, United States
Great Lakes Research Institute
Southfield, Michigan, United States
DM Clinical Research - Southfield - ERN - PPDS
Southfield, Michigan, United States
Mankato Clinic - Premier Drive - Javara - PPDS
Mankato, Minnesota, United States
AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
Richfield, Minnesota, United States
DelRicht Research, LLC - Gulfport - PPDS
Gulfport, Mississippi, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
Creve Coeur, Missouri, United States
Clay Platte Family Medicine - CCT Research
Kansas City, Missouri, United States
Clinvest - National Ave - Headlands - PPDS
Springfield, Missouri, United States
DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS
Springfield, Missouri, United States
Sundance Clinical Research - ERN - PPDS
St Louis, Missouri, United States
DelRicht Clinical Research, LLC - MS. Medicine - PPDS
Town and Country, Missouri, United States
Skyline Medical Center - PC - CCT - PPDS
Elkhorn, Nebraska, United States
Methodist Physicians Clinic - CCT Research - PPDS
Fremont, Nebraska, United States
Velocity Clinical Research (Lincoln - Nebraska) - PPDS
Lincoln, Nebraska, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Midwest Regional Health Services - LLC - CCT - PPDS
Omaha, Nebraska, United States
Papillion Research Center
Papillion, Nebraska, United States
AES - DRS - Synexus Clinical Research US, Inc. - Henderson
Henderson, Nevada, United States
Santa Rosa Urgent Care - Primary Care - CCT - PPDS
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Hassman Research Institute - HRI - Berlin - CenExel - PPDS
Berlin, New Jersey, United States
Velocity Clinical Research - Albuquerque - PPDS
Albuquerque, New Mexico, United States
AXCES Research Group - Sante Fe - ERN - PPDS
Santa Fe, New Mexico, United States
DM Clinical Research - Brooklyn
Brooklyn, New York, United States
AES - DRS - Synexus Clinical Research US, Inc. - New York
New York, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
DelRicht Research, LLC - Charlotte - PPDS
Charlotte, North Carolina, United States
Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS
Charlotte, North Carolina, United States
Monroe Biomedical Research -343 Venus St
Monroe, North Carolina, United States
Trial Management Associates LLC - ERN - PPDS
Wilmington, North Carolina, United States
CTI Clinical Research Center - PPDS
Cincinnati, Ohio, United States
Velocity Clinical Research (Cincinnati - Ohio) - PPDS
Cincinnati, Ohio, United States
AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati, Ohio, United States
Velocity Clinical Research (Cincinnati - Ohio) - PPDS
Cincinnati, Ohio, United States
AES - DRS - Synexus Clinical Research US, Inc. - Columbus
Columbus, Ohio, United States
WellNow Urgent Care & Research - Huber Heights
Huber Heights, Ohio, United States
Tekton Research - Edmond - PPDS
Edmond, Oklahoma, United States
Lynn Institute of East Oklahoma - ERN - PPDS
Oklahoma City, Oklahoma, United States
DelRicht Research, LLC - Internal - Tulsa - PPDS
Tulsa, Oklahoma, United States
Tekton Research - Yukon - PPDS
Yukon, Oklahoma, United States
The Corvallis Clinic, PC - 3680 NW Samaritan Drive
Corvallis, Oregon, United States
Hatboro Medical Associates - CCT - PPDS
Hatboro, Pennsylvania, United States
DM Clinical Research - Philadelphia - ERN - PPDS
Philadelphia, Pennsylvania, United States
AES - DRS - Synexus Clinical Research US, Inc. - Anderson
Anderson, South Carolina, United States
TMA - Myrtle Beach - ERN - PPDS
Myrtle Beach, South Carolina, United States
Velocity Clinical Research - Spartanburg - PPDS
Spartanburg, South Carolina, United States
DelRicht Research, LLC - Hendersonville - PPDS
Hendersonville, Tennessee, United States
AES - DRS - Optimal Research Texas - Austin
Austin, Texas, United States
Benchmark Research - Austin - HyperCore - PPDS
Austin, Texas, United States
Tekton Research - Austin - PPDS
Austin, Texas, United States
Tekton Research Inc
Beaumont, Texas, United States
Headlands Research - Brownsville - Headlands - PPDS
Brownsville, Texas, United States
AES - DRS - Synexus Clinical Research US, Inc. - Dallas
Dallas, Texas, United States
3A Research, LLC
El Paso, Texas, United States
Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS
Fort Worth, Texas, United States
Mount Olympus Medical Research Group - ClinEdge - PPDS
Friendswood, Texas, United States
DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS
Houston, Texas, United States
DM Clinical Research - Bellaire - ERN - PPDS
Houston, Texas, United States
DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
Humble, Texas, United States
DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS
McKinney, Texas, United States
Benchmark Research - San Angelo - HyperCore - PPDS
San Angelo, Texas, United States
Sun Research Institute -427 9th St
San Antonio, Texas, United States
Clinical Trials of Texas, Inc. - PPDS
San Antonio, Texas, United States
IMA Clinical Research - San Antonio - PPDS
San Antonio, Texas, United States
Tekton Research - San Antonio - PPDS
San Antonio, Texas, United States
Privia Medical Group Gulf Coast, PLLC - San Marcos - Javara - PPDS
San Marcos, Texas, United States
Privia Medical Group- North Texas - Stephenville - Javara - PPDS
Stephenville, Texas, United States
DM Clinical Research - Sugarland - ERN - PPDS
Sugar Land, Texas, United States
DM Clinical Research - ERN - PPDS
Tomball, Texas, United States
Cope Family Medicine - CCT - PPDS
Bountiful, Utah, United States
Ogden Clinic - Mountain View - CCT - PPDS
Pleasant View, Utah, United States
Ogden Clinic - Grandview - CCT - PPDS
Roy, Utah, United States
JBR Clinical Research - CenExel JBR - PPDS
Salt Lake City, Utah, United States
AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City
South Salt Lake, Utah, United States
Velocity Clinical Research - Family Practice - Portsmouth - PPDS
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, Wu I, Deng W, Cardona J, Johnson K, Espinosa-Fernandez I, Sinkiewicz M, Urdaneta V, Carmona L, Schaefers K, Girard B, Paila YD, Mehta D, Callendret B, Kostanyan L, Ananworanich J, Miller J, Das R, Shaw CA. Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults >/=50 Years: A Randomized Clinical Trial. JAMA. 2025 Jun 10;333(22):1977-1987. doi: 10.1001/jama.2025.5646.
Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Akache B, Renner TM, Deschatelets L, Dudani R, Harrison BA, McCluskie MJ, Hrapovic S, Blouin J, Wang X, Schuller M, Cui K, Cho JY, Durocher Y. SARS-CoV-2 spike-based virus-like particles incorporate influenza H1/N1 antigens and induce dual immunity in mice. Vaccine. 2024 Dec 2;42(26):126463. doi: 10.1016/j.vaccine.2024.126463. Epub 2024 Oct 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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mRNA-1083-P301
Identifier Type: -
Identifier Source: org_study_id
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