A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

June 23, 2025 updated by: ModernaTX, Inc.

A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to <65 years of age (Cohort B).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8061

Phase

Phase 3

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

United States
- Alabama
  - Anniston, Alabama, United States, 36207-4780
    - Pinnacle Research Group-409 E 10th St
  - Birmingham, Alabama, United States, 35216
    - Accel Research Site - Achieve - Birmingham
  - Cullman, Alabama, United States, 35055-1902
    - Cullman Clinical Trials
- Arizona
  - Mesa, Arizona, United States, 85213-5226
    - Desert Clinical Research - CCT - PPDS
  - Phoenix, Arizona, United States, 85044-6097
    - Foothills Research Center - CCT - PPDS
  - Scottsdale, Arizona, United States, 85260-6411
    - Headlands Research - Scottsdale - PPDS
  - Scottsdale, Arizona, United States, 85260-6742
    - Scottsdale Clinical Trials
  - Tempe, Arizona, United States, 85283-1528
    - Fiel Family & Sports Medicine - PC - CCT - PPDS
- California
  - Cerritos, California, United States, 90703-2544
    - AES - DRS - Synexus Clinical Research US, Inc. - Cerritos
  - Long Beach, California, United States, 90805-4587
    - Long Beach Research Institute, LLC
  - Los Alamitos, California, United States, 90720-3118
    - CenExel Apex (CNS) - Los Alamitos - PPDS
  - Modesto, California, United States, 95350-5365
    - Central Valley Research, LLC
  - North Hollywood, California, United States, 91606-3287
    - Carbon Health- NoHo West Urgent Care and Primary Care
  - Pomona, California, United States, 91767-1800
    - Empire Clinical Research
  - Riverside, California, United States, 92503-4955
    - Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
  - Riverside, California, United States, 92506-3257
    - Clinical Innovations Trials - Riverside - CenExel - PPDS
  - Rolling Hills Estates, California, United States, 90274-7604
    - Peninsula Research Associates - Headlands - PPDS
  - San Diego, California, United States, 92103-2204
    - Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
  - Vista, California, United States, 92083-6051
    - AES - DRS - Synexus Clinical Research US, Inc. - Vista
- Colorado
  - Fort Collins, Colorado, United States, 80525-5752
    - Tekton Research - Fort Collins - PPDS
  - Longmont, Colorado, United States, 80501-6461
    - Tekton Research - Longmont - PPDS
- Connecticut
  - Stamford, Connecticut, United States, 06905-5316
    - Stamford Therapeutics Consortium - ERN - PPDS
  - Waterbury, Connecticut, United States, 06708-3346
    - Chase Medical Research LLC - Waterbury
- Florida
  - Doral, Florida, United States, 33122-1902
    - Revival Research Corporation
  - Hialeah, Florida, United States, 33012
    - Indago Research and Health Center
  - Hollywood, Florida, United States, 33024-2709
    - CenExel RCA - Hollywood
  - Inverness, Florida, United States, 34452
    - Nature Coast Clinical Research
  - Jacksonville, Florida, United States, 32216
    - Jacksonville Center for Clinical Research
  - Jupiter, Florida, United States, 33458-2775
    - Health Awareness - Jupiter - ERN - ERN
  - Largo, Florida, United States, 33777-1359
    - Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS
  - Leesburg, Florida, United States, 34748-5077
    - Flourish Research - Leesburg - PPDS
  - Maitland, Florida, United States, 32751-7258
    - Accel Research Sites - Maitland
  - Melbourne, Florida, United States, 32934-8172
    - AES - DRS - Optimal Research Florida - Melbourne
  - Miami, Florida, United States, 33135-1687
    - Suncoast Research Group LLC - Flourish - PPDS
  - Saint Augustine, Florida, United States, 32086-5775
    - St. Johns Center for Clinical Research - ERN - PPDS
  - Tampa, Florida, United States, 33613-1244
    - ForCare Clinical Research - CenExel FCR - PPDS
- Georgia
  - Atlanta, Georgia, United States, 30328-4018
    - AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
  - Atlanta, Georgia, United States, 30329-2201
    - DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS
  - Decatur, Georgia, United States, 30030-3438
    - iResearch Atlanta - CenExel - PPDS
  - Fayetteville, Georgia, United States, 30214
    - Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
  - Norcross, Georgia, United States, 30092-4544
    - Georgia Clinic - CCT - PPDS
  - Savannah, Georgia, United States, 31406-3928
    - Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
  - Stockbridge, Georgia, United States, 30281-9054
    - Clinical Research Atlanta - ERN - PPDS
- Illinois
  - Chicago, Illinois, United States, 60607-4559
    - Cedar Crosse Research Center
  - Chicago, Illinois, United States, 60602-3960
    - AES - DRS - Synexus Clinical Research US, Inc. - Chicago
  - Chicago, Illinois, United States, 60640-2781
    - Flourish Research - Andersonville - PPDS
  - Morton, Illinois, United States, 61550-2495
    - Koch Family Medicine
  - Peoria, Illinois, United States, 61614
    - AES - DRS - Optimal Research Illinois - Peoria
  - River Forest, Illinois, United States, 60305-1876
    - DM Clinical Research - Chicago - ERN - PPDS
- Indiana
  - Evansville, Indiana, United States, 47714-7513
    - AES - DRS - Synexus Clinical Research US, Inc. - Evansville
  - Valparaiso, Indiana, United States, 46383-2195
    - Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS
- Iowa
  - West Des Moines, Iowa, United States, 50266-8216
    - The Iowa Clinic, P.C. - West Des Moines Campus
- Kansas
  - Lenexa, Kansas, United States, 66219-1389
    - Johnson County Clin-Trials
  - Overland Park, Kansas, United States, 66223-4857
    - Delricht Overland Park
  - Wichita, Kansas, United States, 67218-2913
    - Tekton Research - Wichita - PPDS
- Kentucky
  - Louisville, Kentucky, United States, 40205-3162
    - DelRicht Research, LLC - Louisville - PPDS
  - Versailles, Kentucky, United States, 40383-1947
    - Versailles Family Medicine - CCT - PPDS
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809-3416
    - Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS
  - Covington, Louisiana, United States, 70433-7237
    - Velocity Clinical Research - Covington - PPDS
  - Mandeville, Louisiana, United States, 70471
    - DelRicht Clinical Research, LLC - The Murphy Clinic - PPDS
  - Monroe, Louisiana, United States, 71201-3915
    - IMA Clinical Research - Monroe, LA - PPDS
  - New Orleans, Louisiana, United States, 70115-3584
    - DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS
  - Prairieville, Louisiana, United States, 70769-4222
    - DelRicht Research, LLC - Internal - Baton Rouge - PPDS
- Maryland
  - Annapolis, Maryland, United States, 21401-7050
    - Annapolis Internal Medicine - CCT - PPDS
  - Rockville, Maryland, United States, 20854-2960
    - Velocity Clinical Research (Rockville - Maryland) - PPDS
  - Rockville, Maryland, United States, 20850-6246
    - Advanced Primary Care & Geriatric Care - CCT - PPDS
  - Rockville, Maryland, United States, 20852-3803
    - DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS
  - Silver Spring, Maryland, United States, 20901-4402
    - Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS
- Massachusetts
  - Brookline, Massachusetts, United States, 02445-7113
    - DM Clinical Research - The Brook House - ERN - PPDS
- Michigan
  - Southfield, Michigan, United States, 48076-5412
    - DM Clinical Research - Southfield - ERN - PPDS
  - Southfield, Michigan, United States, 48034-1088
    - Headlands Research - Detroit - Headlands - PPDS
  - Southfield, Michigan, United States, 48075-5400
    - Great Lakes Research Institute
- Minnesota
  - Mankato, Minnesota, United States, 56001-6076
    - Mankato Clinic - Premier Drive - Javara - PPDS
  - Richfield, Minnesota, United States, 55423-2590
    - AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
- Mississippi
  - Gulfport, Mississippi, United States, 39503-4176
    - DelRicht Research, LLC - Gulfport - PPDS
- Missouri
  - Creve Coeur, Missouri, United States, 63141-7084
    - AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
  - Kansas City, Missouri, United States, 64151-2411
    - Clay Platte Family Medicine - CCT Research
  - Saint Louis, Missouri, United States, 63141-7068
    - Sundance Clinical Research - ERN - PPDS
  - Springfield, Missouri, United States, 65807-6012
    - Clinvest - National Ave - Headlands - PPDS
  - Springfield, Missouri, United States, 65807-7303
    - DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS
  - Town And Country, Missouri, United States, 63017-8209
    - DelRicht Clinical Research, LLC - MS. Medicine - PPDS
- Nebraska
  - Elkhorn, Nebraska, United States, 68022-2889
    - Skyline Medical Center - PC - CCT - PPDS
  - Fremont, Nebraska, United States, 68025-2592
    - Methodist Physicians Clinic - CCT Research - PPDS
  - Lincoln, Nebraska, United States, 68510-4855
    - Velocity Clinical Research (Lincoln - Nebraska) - PPDS
  - Omaha, Nebraska, United States, 68134
    - Velocity Clinical Research
  - Omaha, Nebraska, United States, 68144
    - Midwest Regional Health Services - LLC - CCT - PPDS
  - Papillion, Nebraska, United States, 68046-4194
    - Papillion Research Center
- Nevada
  - Henderson, Nevada, United States, 89052-3992
    - AES - DRS - Synexus Clinical Research US, Inc. - Henderson
  - Las Vegas, Nevada, United States, 89119-5483
    - Santa Rosa Urgent Care - Primary Care - CCT - PPDS
  - North Las Vegas, Nevada, United States, 89030-7187
    - Las Vegas Clinical Trials
- New Jersey
  - Berlin, New Jersey, United States, 08009
    - Hassman Research Institute - HRI - Berlin - CenExel - PPDS
- New Mexico
  - Albuquerque, New Mexico, United States, 87107-4503
    - Velocity Clinical Research - Albuquerque - PPDS
  - Santa Fe, New Mexico, United States, 87505-4753
    - AXCES Research Group - Sante Fe - ERN - PPDS
- New York
  - Brooklyn, New York, United States, 11220-5906
    - DM Clinical Research - Brooklyn
  - New York, New York, United States, 10017-4008
    - AES - DRS - Synexus Clinical Research US, Inc. - New York
  - Rochester, New York, United States, 14609-3173
    - Rochester Clinical Research, Inc
- North Carolina
  - Charlotte, North Carolina, United States, 28205-5078
    - DelRicht Research, LLC - Charlotte - PPDS
  - Charlotte, North Carolina, United States, 28287-3884
    - Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS
  - Monroe, North Carolina, United States, 28112-4025
    - Monroe Biomedical Research -343 Venus St
  - Wilmington, North Carolina, United States, 28403-6235
    - Trial Management Associates LLC - ERN - PPDS
- Ohio
  - Cincinnati, Ohio, United States, 45236-3669
    - AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
  - Cincinnati, Ohio, United States, 45212
    - CTI Clinical Research Center - PPDS
  - Cincinnati, Ohio, United States, 45219-2975
    - Velocity Clinical Research (Cincinnati - Ohio) - PPDS
  - Cincinnati, Ohio, United States, 45246-2316
    - Velocity Clinical Research (Cincinnati - Ohio) - PPDS
  - Columbus, Ohio, United States, 43212-3119
    - AES - DRS - Synexus Clinical Research US, Inc. - Columbus
  - Huber Heights, Ohio, United States, 45424-4019
    - WellNow Urgent Care & Research - Huber Heights
- Oklahoma
  - Edmond, Oklahoma, United States, 73013-5478
    - Tekton Research - Edmond - PPDS
  - Oklahoma City, Oklahoma, United States, 73111-3324
    - Lynn Institute of East Oklahoma - ERN - PPDS
  - Tulsa, Oklahoma, United States, 74133-8902
    - DelRicht Research, LLC - Internal - Tulsa - PPDS
  - Yukon, Oklahoma, United States, 73099-9518
    - Tekton Research - Yukon - PPDS
- Oregon
  - Corvallis, Oregon, United States, 97330-3737
    - The Corvallis Clinic, PC - 3680 NW Samaritan Drive
- Pennsylvania
  - Hatboro, Pennsylvania, United States, 19040-2045
    - Hatboro Medical Associates - CCT - PPDS
  - Philadelphia, Pennsylvania, United States, 19107-1530
    - DM Clinical Research - Philadelphia - ERN - PPDS
- South Carolina
  - Anderson, South Carolina, United States, 29621-2062
    - AES - DRS - Synexus Clinical Research US, Inc. - Anderson
  - Myrtle Beach, South Carolina, United States, 29572-4610
    - TMA - Myrtle Beach - ERN - PPDS
  - Spartanburg, South Carolina, United States, 29303-4225
    - Velocity Clinical Research - Spartanburg - PPDS
- Tennessee
  - Hendersonville, Tennessee, United States, 37075-8947
    - DelRicht Research, LLC - Hendersonville - PPDS
- Texas
  - Austin, Texas, United States, 78705-2655
    - AES - DRS - Optimal Research Texas - Austin
  - Austin, Texas, United States, 78705-3298
    - Benchmark Research - Austin - HyperCore - PPDS
  - Austin, Texas, United States, 78745
    - Tekton Research - Austin - PPDS
  - Beaumont, Texas, United States, 77706-3061
    - Tekton Research Inc
  - Brownsville, Texas, United States, 78526-4332
    - Headlands Research - Brownsville - Headlands - PPDS
  - Dallas, Texas, United States, 75234-7858
    - AES - DRS - Synexus Clinical Research US, Inc. - Dallas
  - El Paso, Texas, United States, 79925
    - 3A Research, LLC
  - Fort Worth, Texas, United States, 76133-4953
    - Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS
  - Friendswood, Texas, United States, 77546
    - Mount Olympus Medical Research Group - ClinEdge - PPDS
  - Houston, Texas, United States, 77065-5685
    - DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS
  - Houston, Texas, United States, 77081-4648
    - DM Clinical Research - Bellaire - ERN - PPDS
  - Humble, Texas, United States, 77338-4205
    - DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
  - McKinney, Texas, United States, 75070-8481
    - DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS
  - San Angelo, Texas, United States, 76904-7610
    - Benchmark Research - San Angelo - HyperCore - PPDS
  - San Antonio, Texas, United States, 78229-3539
    - Clinical Trials of Texas, Inc. - PPDS
  - San Antonio, Texas, United States, 78215-1528
    - Sun Research Institute -427 9th St
  - San Antonio, Texas, United States, 78229
    - IMA Clinical Research - San Antonio - PPDS
  - San Antonio, Texas, United States, 78229
    - Tekton Research - San Antonio - PPDS
  - San Marcos, Texas, United States, 78666-9734
    - Privia Medical Group Gulf Coast, PLLC - San Marcos - Javara - PPDS
  - Stephenville, Texas, United States, 76401-1860
    - Privia Medical Group- North Texas - Stephenville - Javara - PPDS
  - Sugar Land, Texas, United States, 77478-4913
    - DM Clinical Research - Sugarland - ERN - PPDS
  - Tomball, Texas, United States, 77375-3330
    - DM Clinical Research - ERN - PPDS
- Utah
  - Bountiful, Utah, United States, 84010-4862
    - Cope Family Medicine - CCT - PPDS
  - Pleasant View, Utah, United States, 84404-4791
    - Ogden Clinic - Mountain View - CCT - PPDS
  - Roy, Utah, United States, 84067-9438
    - Ogden Clinic - Grandview - CCT - PPDS
  - S. Salt Lake, Utah, United States, 84106-1466
    - AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City
  - Salt Lake City, Utah, United States, 84107-4536
    - JBR Clinical Research - CenExel JBR - PPDS
- Virginia
  - Portsmouth, Virginia, United States, 23703-3200
    - Velocity Clinical Research - Family Practice - Portsmouth - PPDS
- Washington
  - Wenatchee, Washington, United States, 98801-2028
    - Wenatchee Valley Hospital & Clinics Campus

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
Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

Healthy adults either ≥65 years of age (Cohort A) or 50 to <65 years of age (Cohort B) at the time of consent (Screening Visit).
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:

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 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.

Note: 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: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: mRNA-1083 Suspension for injection Biological: Placebo 0.9% sodium chloride suspension for injection
Active Comparator: 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.	Biological: Influenza Vaccine Commercially available formulation (Suspension for injection [pre-filled syringe]) Biological: COVID-19 Vaccine Commercially available formulation (Suspension for injection)
Experimental: 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.	Biological: mRNA-1083 Suspension for injection Biological: Placebo 0.9% sodium chloride suspension for injection
Active Comparator: 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.	Biological: Influenza Vaccine Commercially available formulation (Suspension for injection [pre-filled syringe]) Biological: COVID-19 Vaccine Commercially available formulation (Suspension for injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay Time Frame: Day 29	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. The Per Protocol Immunogenicity Set (PPIS) included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative reverse transcription polymerase chain reaction (RT-PCR) test for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.	Day 29
GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) Time Frame: Day 29	SARS-CoV-2 strain included Omicron XBB.1.5 antibody. The PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.	Day 29
Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay Time Frame: Baseline to Day 29	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a Day 29 postinjection level ≥1:40 if Baseline was <1:10 or a 4-fold or greater rise if Baseline was ≥1:10 in anti-hemagglutinin (HA) antibodies measured by HAI assay. The PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.	Baseline to Day 29
SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA Time Frame: Baseline to Day 29	SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as a Day 29 postinjection level ≥4-fold rise if Baseline was ≥lower limit of quantification (LLOQ) or ≥4×LLOQ if Baseline value was <LLOQ in the nAb values measured by PsVNA. LLOQ was 38 arbitrary unit (AU)/milliliter (mL). The PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.	Baseline to Day 29
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Time Frame: Up to 7 days after study injection	Solicited ARs (local and systemic) were reported by participants an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.	Up to 7 days after study injection
Number of Participants With Unsolicited Adverse Events (AEs) Time Frame: Up to 28 days after study injection	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.	Up to 28 days after study injection
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation Time Frame: Day 1 through Day 181	An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site. Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.	Day 1 through Day 181

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay Time Frame: Day 1, Day 29	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.	Day 1, Day 29
GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA Time Frame: Day 1, Day 29	SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.	Day 1, Day 29
GM Level of Antibodies for Influenza, as Measured by Microneutralization (MN) Assay Time Frame: Day 29	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. The PPIS for MN assay included a subset of randomized participants who received study intervention to be tested for MN, complied with the timing of immunogenicity blood sampling collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.	Day 29
GMFR of Antibodies for Influenza, as Measured by MN Assay Time Frame: Day 1, Day 29	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. The PPIS for MN assay included a subset of randomized participants who received study intervention to be tested for MN, complied with the timing of immunogenicity blood sampling collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.	Day 1, Day 29

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Deaths Related to Study Drug mRNA-1083 and Placebo Time Frame: Day 1 through Day 181	A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, irrespective of its perceived relationship to the study drug. The Investigator assessed the causality by determining whether there was a reasonable possibility that the death was related to the study drug, using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable.	Day 1 through Day 181
Number of Deaths Related to Control Drug Influenza Vaccine and COVID-19 Vaccine Time Frame: Day 1 through Day 181	A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, irrespective of its perceived relationship to the study drug. The Investigator assessed the causality by determining whether there was a reasonable possibility that the death was related to the study drug, using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable.	Day 1 through Day 181

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)

October 19, 2023

Primary Completion (Actual)

May 28, 2024

Study Completion (Actual)

May 28, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

mRNA-1083-P301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Influenza

Novartis Vaccines

Completed

Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects

Influenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza Virus

Belgium
Gamaleya Research Institute of Epidemiology and...

Completed

The Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac

Influenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1

Russian Federation
Vanderbilt University Medical Center
Human Vaccines Project

Completed

Kinetics of the Immune Response to Inactivated Influenza Vaccine in Healthy Adults (KIRV)

Vaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1

United States
Canadian Immunization Research Network
CHU de Quebec-Universite Laval; McGill University Health Centre/Research Institute... and other collaborators

Active, not recruiting

Immunogenicity and Safety of 2 Doses of Avian Influenza A (H5N1) Vaccine Administered 3 vs. 8 Weeks Apart

Avian Influenza | H5N1 Virus | H5N1 Influenza | Avian Influenza A Virus

Canada
NPO Petrovax

Completed

A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus

Vaccine Reaction | Influenza | Influenza, Human | Influenza A | Acute Respiratory Infection | Influenza Type B | Flu | Influenza A H3N2 | Influenza A H1N1 | Flu, Human | Influenza Epidemic

Russian Federation
National Institute of Allergy and Infectious Diseases...

Completed

2013/2017 H7N9 Prime-Boost Interval

Influenza Immunisation | Avian Influenza

United States
National Institute of Allergy and Infectious Diseases...

Completed

2017 A/H7N9 IIV Revaccination

Influenza Immunisation | Avian Influenza

United States
National Institute of Allergy and Infectious Diseases...

Completed

Safety/Efficacy Study of Seqirus A/H7N9 IIV With or Without MF59(R) Adjuvant to Prevent Avian Influenza

Influenza Immunisation | Avian Influenza

United States
National Institute of Allergy and Infectious Diseases...

Completed

Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4

Influenza | Influenza Immunisation | Avian Influenza

United States
National Institute of Allergy and Infectious Diseases...

Completed

H5N1 With or Without Topical Aldara in Healthy Adults

Influenza Immunisation | Avian Influenza

United States

Clinical Trials on mRNA-1083

ModernaTX, Inc.

Completed

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

Influenza | SARS-CoV-2

United States
ModernaTX, Inc.

Completed

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)

Influenza | SARS-CoV-2

Canada, United States
BeBetter Med Inc

Recruiting

Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer | EGFR Exon 20 Insertion Mutation

China
ModernaTX, Inc.

Completed

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age

COVID-19 | Influenza

Taiwan, Japan, South Korea
Sumitomo Pharma America, Inc.

Recruiting

A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease

Parkinson's Disease

United States
ModernaTX, Inc.

Completed

A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults

Influenza | SARS-CoV-2

United States
ModernaTX, Inc.

Completed

A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants

SARS-CoV-2

United States
ModernaTX, Inc.

Completed

Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults

Influenza

United States
ModernaTX, Inc.

Completed

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters

SARS-CoV-2

United States
ModernaTX, Inc.

Completed

A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old

Influenza | SARS-CoV-2 | RSV

United Kingdom, Australia, United States

A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Influenza

Clinical Trials on mRNA-1083

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations