AzTrials
AzTrials

SARS-CoV-2Phase 3NCT06097273

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

A Phase 3 study testing mRNA-1083, Influenza Vaccine and COVID-19 Vaccine in people with SARS-CoV-2 and Influenza, run by ModernaTX, Inc. at 146 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2, Influenza
What is being tested?
mRNA-1083, Influenza Vaccine and COVID-19 Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,061 participants
Where
146 sitesUnited States
Study dates
19 Oct 2023to 28 May 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

146 sites in 1 country.

146 sites in 1 country

United States146 sites

  • Velocity Clinical Research - Albuquerque - PPDS

    Albuquerque, New Mexico, 87107-4503

  • AES - DRS - Synexus Clinical Research US, Inc. - Anderson

    Anderson, South Carolina, 29621-2062

  • Annapolis Internal Medicine - CCT - PPDS

    Annapolis, Maryland, 21401-7050

  • Pinnacle Research Group-409 E 10th St

    Anniston, Alabama, 36207-4780

  • AES - DRS - Synexus Clinical Research US, Inc. - Atlanta

    Atlanta, Georgia, 30328-4018

  • DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS

    Atlanta, Georgia, 30329-2201

  • AES - DRS - Optimal Research Texas - Austin

    Austin, Texas, 78705-2655

  • Benchmark Research - Austin - HyperCore - PPDS

    Austin, Texas, 78705-3298

  • Tekton Research - Austin - PPDS

    Austin, Texas, 78745

  • Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS

    Baton Rouge, Louisiana, 70809-3416

  • Tekton Research Inc

    Beaumont, Texas, 77706-3061

  • Hassman Research Institute - HRI - Berlin - CenExel - PPDS

    Berlin, New Jersey, 08009

  • Accel Research Site - Achieve - Birmingham

    Birmingham, Alabama, 35216

  • Cope Family Medicine - CCT - PPDS

    Bountiful, Utah, 84010-4862

  • DM Clinical Research - The Brook House - ERN - PPDS

    Brookline, Massachusetts, 02445-7113

  • DM Clinical Research - Brooklyn

    Brooklyn, New York, 11220-5906

  • Headlands Research - Brownsville - Headlands - PPDS

    Brownsville, Texas, 78526-4332

  • AES - DRS - Synexus Clinical Research US, Inc. - Cerritos

    Cerritos, California, 90703-2544

  • DelRicht Research, LLC - Charlotte - PPDS

    Charlotte, North Carolina, 28205-5078

  • Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS

    Charlotte, North Carolina, 28287-3884

  • AES - DRS - Synexus Clinical Research US, Inc. - Chicago

    Chicago, Illinois, 60602-3960

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607-4559

  • Flourish Research - Andersonville - PPDS

    Chicago, Illinois, 60640-2781

  • CTI Clinical Research Center - PPDS

    Cincinnati, Ohio, 45212

  • Velocity Clinical Research (Cincinnati - Ohio) - PPDS

    Cincinnati, Ohio, 45219-2975

  • AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati

    Cincinnati, Ohio, 45236-3669

  • Velocity Clinical Research (Cincinnati - Ohio) - PPDS

    Cincinnati, Ohio, 45246-2316

  • AES - DRS - Synexus Clinical Research US, Inc. - Columbus

    Columbus, Ohio, 43212-3119

  • The Corvallis Clinic, PC - 3680 NW Samaritan Drive

    Corvallis, Oregon, 97330-3737

  • Velocity Clinical Research - Covington - PPDS

    Covington, Louisiana, 70433-7237

  • AES - DRS - Synexus Clinical Research US, Inc. - St. Louis

    Creve Coeur, Missouri, 63141-7084

  • Cullman Clinical Trials

    Cullman, Alabama, 35055-1902

  • AES - DRS - Synexus Clinical Research US, Inc. - Dallas

    Dallas, Texas, 75234-7858

  • iResearch Atlanta - CenExel - PPDS

    Decatur, Georgia, 30030-3438

  • Revival Research Corporation

    Doral, Florida, 33122-1902

  • Tekton Research - Edmond - PPDS

    Edmond, Oklahoma, 73013-5478

  • 3A Research, LLC

    El Paso, Texas, 79925

  • Skyline Medical Center - PC - CCT - PPDS

    Elkhorn, Nebraska, 68022-2889

  • AES - DRS - Synexus Clinical Research US, Inc. - Evansville

    Evansville, Indiana, 47714-7513

  • Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS

    Fayetteville, Georgia, 30214

  • Tekton Research - Fort Collins - PPDS

    Fort Collins, Colorado, 80525-5752

  • Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS

    Fort Worth, Texas, 76133-4953

  • Methodist Physicians Clinic - CCT Research - PPDS

    Fremont, Nebraska, 68025-2592

  • Mount Olympus Medical Research Group - ClinEdge - PPDS

    Friendswood, Texas, 77546

  • DelRicht Research, LLC - Gulfport - PPDS

    Gulfport, Mississippi, 39503-4176

  • Hatboro Medical Associates - CCT - PPDS

    Hatboro, Pennsylvania, 19040-2045

  • AES - DRS - Synexus Clinical Research US, Inc. - Henderson

    Henderson, Nevada, 89052-3992

  • DelRicht Research, LLC - Hendersonville - PPDS

    Hendersonville, Tennessee, 37075-8947

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • CenExel RCA - Hollywood

    Hollywood, Florida, 33024-2709

  • DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS

    Houston, Texas, 77065-5685

  • DM Clinical Research - Bellaire - ERN - PPDS

    Houston, Texas, 77081-4648

  • WellNow Urgent Care & Research - Huber Heights

    Huber Heights, Ohio, 45424-4019

  • DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS

    Humble, Texas, 77338-4205

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida, 32216

  • Health Awareness - Jupiter - ERN - ERN

    Jupiter, Florida, 33458-2775

  • Clay Platte Family Medicine - CCT Research

    Kansas City, Missouri, 64151-2411

  • Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS

    Largo, Florida, 33777-1359

  • Santa Rosa Urgent Care - Primary Care - CCT - PPDS

    Las Vegas, Nevada, 89119-5483

  • Flourish Research - Leesburg - PPDS

    Leesburg, Florida, 34748-5077

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219-1389

  • Velocity Clinical Research (Lincoln - Nebraska) - PPDS

    Lincoln, Nebraska, 68510-4855

  • Long Beach Research Institute, LLC

    Long Beach, California, 90805-4587

  • Tekton Research - Longmont - PPDS

    Longmont, Colorado, 80501-6461

  • CenExel Apex (CNS) - Los Alamitos - PPDS

    Los Alamitos, California, 90720-3118

  • DelRicht Research, LLC - Louisville - PPDS

    Louisville, Kentucky, 40205-3162

  • Accel Research Sites - Maitland

    Maitland, Florida, 32751-7258

  • DelRicht Clinical Research, LLC - The Murphy Clinic - PPDS

    Mandeville, Louisiana, 70471

  • Mankato Clinic - Premier Drive - Javara - PPDS

    Mankato, Minnesota, 56001-6076

  • DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS

    McKinney, Texas, 75070-8481

  • AES - DRS - Optimal Research Florida - Melbourne

    Melbourne, Florida, 32934-8172

  • Desert Clinical Research - CCT - PPDS

    Mesa, Arizona, 85213-5226

  • Suncoast Research Group LLC - Flourish - PPDS

    Miami, Florida, 33135-1687

  • Central Valley Research, LLC

    Modesto, California, 95350-5365

  • IMA Clinical Research - Monroe, LA - PPDS

    Monroe, Louisiana, 71201-3915

  • Monroe Biomedical Research -343 Venus St

    Monroe, North Carolina, 28112-4025

  • Koch Family Medicine

    Morton, Illinois, 61550-2495

  • TMA - Myrtle Beach - ERN - PPDS

    Myrtle Beach, South Carolina, 29572-4610

  • DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS

    New Orleans, Louisiana, 70115-3584

  • AES - DRS - Synexus Clinical Research US, Inc. - New York

    New York, New York, 10017-4008

  • Georgia Clinic - CCT - PPDS

    Norcross, Georgia, 30092-4544

  • Carbon Health- NoHo West Urgent Care and Primary Care

    North Hollywood, California, 91606-3287

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030-7187

  • Lynn Institute of East Oklahoma - ERN - PPDS

    Oklahoma City, Oklahoma, 73111-3324

  • Velocity Clinical Research

    Omaha, Nebraska, 68134

  • Midwest Regional Health Services - LLC - CCT - PPDS

    Omaha, Nebraska, 68144

  • Delricht Overland Park

    Overland Park, Kansas, 66223-4857

  • Papillion Research Center

    Papillion, Nebraska, 68046-4194

  • AES - DRS - Optimal Research Illinois - Peoria

    Peoria, Illinois, 61614

  • DM Clinical Research - Philadelphia - ERN - PPDS

    Philadelphia, Pennsylvania, 19107-1530

  • Foothills Research Center - CCT - PPDS

    Phoenix, Arizona, 85044-6097

  • Ogden Clinic - Mountain View - CCT - PPDS

    Pleasant View, Utah, 84404-4791

  • Empire Clinical Research

    Pomona, California, 91767-1800

  • Velocity Clinical Research - Family Practice - Portsmouth - PPDS

    Portsmouth, Virginia, 23703-3200

  • DelRicht Research, LLC - Internal - Baton Rouge - PPDS

    Prairieville, Louisiana, 70769-4222

  • AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis

    Richfield, Minnesota, 55423-2590

  • DM Clinical Research - Chicago - ERN - PPDS

    River Forest, Illinois, 60305-1876

  • Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS

    Riverside, California, 92503-4955

  • Clinical Innovations Trials - Riverside - CenExel - PPDS

    Riverside, California, 92506-3257

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609-3173

  • Advanced Primary Care & Geriatric Care - CCT - PPDS

    Rockville, Maryland, 20850-6246

  • DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS

    Rockville, Maryland, 20852-3803

  • Velocity Clinical Research (Rockville - Maryland) - PPDS

    Rockville, Maryland, 20854-2960

  • Peninsula Research Associates - Headlands - PPDS

    Rolling Hills Estates, California, 90274-7604

  • Ogden Clinic - Grandview - CCT - PPDS

    Roy, Utah, 84067-9438

  • St. Johns Center for Clinical Research - ERN - PPDS

    Saint Augustine, Florida, 32086-5775

  • JBR Clinical Research - CenExel JBR - PPDS

    Salt Lake City, Utah, 84107-4536

  • Benchmark Research - San Angelo - HyperCore - PPDS

    San Angelo, Texas, 76904-7610

  • Sun Research Institute -427 9th St

    San Antonio, Texas, 78215-1528

  • Clinical Trials of Texas, Inc. - PPDS

    San Antonio, Texas, 78229-3539

  • IMA Clinical Research - San Antonio - PPDS

    San Antonio, Texas, 78229

  • Tekton Research - San Antonio - PPDS

    San Antonio, Texas, 78229

  • Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS

    San Diego, California, 92103-2204

  • Privia Medical Group Gulf Coast, PLLC - San Marcos - Javara - PPDS

    San Marcos, Texas, 78666-9734

  • AXCES Research Group - Sante Fe - ERN - PPDS

    Santa Fe, New Mexico, 87505-4753

  • Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS

    Savannah, Georgia, 31406-3928

  • Headlands Research - Scottsdale - PPDS

    Scottsdale, Arizona, 85260-6411

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260-6742

  • Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS

    Silver Spring, Maryland, 20901-4402

  • AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City

    South Salt Lake, Utah, 84106-1466

  • Headlands Research - Detroit - Headlands - PPDS

    Southfield, Michigan, 48034-1088

  • Great Lakes Research Institute

    Southfield, Michigan, 48075-5400

  • DM Clinical Research - Southfield - ERN - PPDS

    Southfield, Michigan, 48076-5412

  • Velocity Clinical Research - Spartanburg - PPDS

    Spartanburg, South Carolina, 29303-4225

  • Clinvest - National Ave - Headlands - PPDS

    Springfield, Missouri, 65807-6012

  • DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS

    Springfield, Missouri, 65807-7303

  • Sundance Clinical Research - ERN - PPDS

    St Louis, Missouri, 63141-7068

  • Stamford Therapeutics Consortium - ERN - PPDS

    Stamford, Connecticut, 06905-5316

  • Privia Medical Group- North Texas - Stephenville - Javara - PPDS

    Stephenville, Texas, 76401-1860

  • Clinical Research Atlanta - ERN - PPDS

    Stockbridge, Georgia, 30281-9054

  • DM Clinical Research - Sugarland - ERN - PPDS

    Sugar Land, Texas, 77478-4913

  • ForCare Clinical Research - CenExel FCR - PPDS

    Tampa, Florida, 33613-1244

  • Fiel Family & Sports Medicine - PC - CCT - PPDS

    Tempe, Arizona, 85283-1528

  • DM Clinical Research - ERN - PPDS

    Tomball, Texas, 77375-3330

  • DelRicht Clinical Research, LLC - MS. Medicine - PPDS

    Town and Country, Missouri, 63017-8209

  • DelRicht Research, LLC - Internal - Tulsa - PPDS

    Tulsa, Oklahoma, 74133-8902

  • Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS

    Valparaiso, Indiana, 46383-2195

  • Versailles Family Medicine - CCT - PPDS

    Versailles, Kentucky, 40383-1947

  • AES - DRS - Synexus Clinical Research US, Inc. - Vista

    Vista, California, 92083-6051

  • Chase Medical Research LLC - Waterbury

    Waterbury, Connecticut, 06708-3346

  • Wenatchee Valley Hospital & Clinics Campus

    Wenatchee, Washington, 98801-2028

  • The Iowa Clinic, P.C. - West Des Moines Campus

    West Des Moines, Iowa, 50266-8216

  • Tekton Research - Wichita - PPDS

    Wichita, Kansas, 67218-2913

  • Trial Management Associates LLC - ERN - PPDS

    Wilmington, North Carolina, 28403-6235

  • Tekton Research - Yukon - PPDS

    Yukon, Oklahoma, 73099-9518

Other trials in United States

About this study

Official title: 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).

Being tested
mRNA-1083, Placebo, Influenza Vaccine, COVID-19 Vaccine
Keywords
mRNA-1083, mRNA-1083 Vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, Influenza Vaccine, Moderna
Medical subject headings
Influenza, Human, Coronavirus Infections, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1083Biological

    Suspension for injection

  • PlaceboBiological

    0.9% sodium chloride suspension for injection

  • Influenza VaccineBiological

    Commercially available formulation (Suspension for injection [pre-filled syringe])

  • COVID-19 VaccineBiological

    Commercially available formulation (Suspension for injection)

Study groups in NCT06097273
Study groupRoleWhat they receive
Cohort A1: mRNA-1083 and PlaceboExperimentalParticipants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1.
Receives: Biological: mRNA-1083; Biological: Placebo
Cohort A2: Influenza Vaccine and COVID-19 VaccineActive comparatorParticipants 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.
Receives: Biological: Influenza Vaccine; Biological: COVID-19 Vaccine
Cohort B1: mRNA-1083 and PlaceboExperimentalParticipants of age 50 to <65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1.
Receives: Biological: mRNA-1083; Biological: Placebo
Cohort B2: Influenza Vaccine and COVID-19 VaccineActive comparatorParticipants 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.
Receives: Biological: Influenza Vaccine; Biological: COVID-19 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay

    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.

    Measured: Day 29

  2. GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)

    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.

    Measured: Day 29

  3. Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay

    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.

    Measured: Baseline to Day 29

  4. SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA

    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.

    Measured: Baseline to Day 29

  5. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

    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.

    Measured: Up to 7 days after study injection

  6. Number of Participants With Unsolicited Adverse Events (AEs)

    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.

    Measured: Up to 28 days after study injection

  7. Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation

    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.

    Measured: Day 1 through Day 181

Secondary outcomes (4)

  1. Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay

    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.

    Measured: Day 1, Day 29

  2. GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA

    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.

    Measured: Day 1, Day 29

  3. GM Level of Antibodies for Influenza, as Measured by Microneutralization (MN) Assay

    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.

    Measured: Day 29

  4. GMFR of Antibodies for Influenza, as Measured by MN Assay

    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.

    Measured: Day 1, Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start19 Oct 2023
  3. Primary completion28 May 2024
  4. Study completion28 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8,061 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06097273
Sponsor's protocol ID
mRNA-1083-P301
Status last verified
Jun 2025
First submitted
18 Oct 2023
Last updated
1 Jul 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kostanyan L, Wu I, Sinkiewicz M, Cardona J, Johnson K, Das R. Safety and durability of influenza and SARS-CoV-2 antibody responses through 6 months after a single dose of mRNA-1083, a multicomponent influenza and COVID-19 vaccine, in adults >/=50 years. Hum Vaccin Immunother. 2026 Dec;22(1):2675021. doi: 10.1080/21645515.2026.2675021. Epub 2026 May 29.

    PubMed 42213900

  • 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.

    PubMed 40332892

  • 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.

    PubMed 39481241

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mRNA-1083, Influenza Vaccine and COVID-19 Vaccine in people with SARS-CoV-2 and Influenza, run by ModernaTX, Inc. at 146 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay (time frame: Day 29). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06097273, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.

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