A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
SARS-CoV-2, Influenza
About this trial
This is an interventional prevention trial for SARS-CoV-2 focused on measuring mRNA-1083, mRNA-1083 Vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, Influenza Vaccine, Moderna
Eligibility Criteria
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.
Sites / Locations
- Pinnacle Research Group-409 E 10th St
- Accel Research Site - Achieve - Birmingham
- Cullman Clinical Trials
- Lenzmeier Family Medicine - CCT - PPDS
- Centricity Research - Mesa - HyperCore - PPDS
- Desert Clinical Research - CCT - PPDS
- Foothills Research Center - CCT - PPDS
- Headlands Research - Scottsdale - PPDS
- Fiel Family & Sports Medicine - PC - CCT - PPDS
- Noble Clinical Research
- AES - DRS - Synexus Clinical Research US, Inc. - Tucson
- AES - DRS - Synexus Clinical Research US, Inc. - Cerritos
- Velocity Clinical Research, San Diego
- Long Beach Research Institute, LLC
- CenExel Apex (CNS) - Los Alamitos - PPDS
- Central Valley Research, LLC
- Carbon Health- NoHo West Urgent Care and Primary Care
- Carbon Health - Oakland
- Empire Clinical Research
- Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
- Clinical Innovations Trials - Riverside - CenExel - PPDS
- Peninsula Research Associates - Headlands - PPDS
- Benchmark Research - Sacramento - HyperCore - PPDS
- Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
- AME Medical Group, Inc
- AES - DRS - Synexus Clinical Research US, Inc. - Vista
- Tekton Research - Fort Collins - PPDS
- Tekton Research - Longmont - PPDS
- Stamford Therapeutics Consortium - ERN - PPDS
- Chase Medical Research LLC - Waterbury
- Revival Research Corporation
- Indago Research and Health Center
- CenExel RCA - Hollywood
- Nature Coast Clinical Research
- Jacksonville Center For Clinical Research
- Health Awareness - Jupiter - ERN - ERN
- Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS
- Flourish Research - Leesburg - PPDS
- Accel Research Sites - Maitland
- AES - DRS - Optimal Research Florida - Melbourne
- Suncoast Research Group LLC - Flourish - PPDS
- Flourish Research - Miami - PPDS
- Suncoast Research Associates, LLC
- St. Johns Center for Clinical Research - ERN - PPDS
- ForCare Clinical Research - CenExel FCR - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
- DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS
- Atlanta Center for Medical Research - CenExel ACMR - PPDS
- iResearch Atlanta - CenExel - PPDS
- Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
- Georgia Clinic - CCT - PPDS
- Centricity Research Southeast Lung Associates Research - Hypercore - PPDS
- iResearch Savannah - CenExel - PPDS
- Clinical Research Atlanta - ERN - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Chicago
- Cedar Crosse Research Center
- Flourish Research - Andersonville - PPDS
- Koch Family Medicine
- AES - DRS - Optimal Research Illinois - Peoria
- DM Clinical Research - Chicago - ERN - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Evansville
- Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS
- The Iowa Clinic, P.C. - West Des Moines Campus
- Johnson County Clin-Trials
- Tekton Research - Wichita - PPDS
- DelRicht Research, LLC - Louisville - PPDS
- Versailles Family Medicine - CCT - PPDS
- Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS
- Velocity Clinical Research - Covington - PPDS
- IMA Clinical Research - Monroe, LA - PPDS
- DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS
- DelRicht Research, LLC - Internal - Baton Rouge - PPDS
- Annapolis Internal Medicine - CCT - PPDS
- Advanced Primary Care & Geriatric Care - CCT - PPDS
- DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS
- Velocity Clinical Research (Rockville - Maryland) - PPDS
- Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS
- DM Clinical Research - The Brook House - ERN - PPDS
- Headlands Research - Detroit - Headlands - PPDS
- Great Lakes Research Institute
- DM Clinical Research - Southfield - ERN - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
- DelRicht Research, LLC - Gulfport - PPDS
- Clay Platte Family Medicine - CCT Research
- Sundance Clinical Research - ERN - PPDS
- Clinvest - National Ave - Headlands - PPDS
- DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS
- DelRicht Clinical Research, LLC - MS. Medicine - PPDS
- Skyline Medical Center - PC - CCT - PPDS
- Methodist Physicians Clinic - CCT Research - PPDS
- Velocity Clinical Research (Lincoln - Nebraska) - PPDS
- Be Well Clinical Studies, LLC
- Velocity Clinical Research
- Midwest Regional Health Services - LLC - CCT - PPDS
- Papillion Research Center
- AES - DRS - Synexus Clinical Research US, Inc. - Henderson
- Henderson Clinical Trials
- Santa Rosa Urgent Care - Primary Care - CCT - PPDS
- Las Vegas Clinical Trials
- Hassman Research Institute - HRI - Berlin - CenExel - PPDS
- Velocity Clinical Research - Albuquerque - PPDS
- AXCES Research Group - Sante Fe - ERN - PPDS
- Prime Global Research, Inc.
- DM Clinical Research - Brooklyn
- AES - DRS - Synexus Clinical Research US, Inc. - New York
- Rochester Clinical Research, Inc
- WellNow Urgent Care and Clinical Research - Niskayuna
- DelRicht Research, LLC - Charlotte - PPDS
- Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS
- Monroe Biomedical Research -343 Venus St
- Trial Management Associates LLC - ERN - PPDS
- CTI Clinical Research Center - PPDS
- Velocity Clinical Research (Cincinnati - Ohio) - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
- Velocity Clinical Research (Cincinnati - Ohio) - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Columbus
- Centricity Research - Columbus - (Ohio) - HyperCore - PPDS
- WellNow Urgent Care & Research - Huber Heights
- Tekton Research - Edmond - PPDS
- Lynn Institute of East Oklahoma - ERN - PPDS
- DelRicht Research, LLC - Internal - Tulsa - PPDS
- Tekton Research - Yukon - PPDS
- The Corvallis Clinic, PC - 3680 NW Samaritan Drive
- Hatboro Medical Associates - CCT - PPDS
- DM Clinical Research - Philadelphia - ERN - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Anderson
- TMA - Myrtle Beach - ERN - PPDS
- Velocity Clinical Research - Spartanburg - PPDS
- DelRicht Research, LLC - Hendersonville - PPDS
- AES - DRS - Optimal Research Texas - Austin
- Benchmark Research - Austin - HyperCore - PPDS
- Tekton Research - Austin - PPDS
- Tekton Research Inc
- Headlands Research - Brownsville - Headlands - PPDS
- 3A Research, LLC
- Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS
- Mount Olympus Medical Research Group - ClinEdge - PPDS
- DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS
- DM Clinical Research - Bellaire - ERN - PPDS
- DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
- Activian Clinical Research
- DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS
- Advances in Health-9430 Broadway St
- Epic Medical Research LLC - Red Oak
- Benchmark Research - San Angelo - HyperCore - PPDS
- Sun Research Institute -427 9th St
- AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
- Clinical Trials of Texas, Inc. - PPDS
- IMA Clinical Research - San Antonio - PPDS
- Tekton Research - San Antonio - PPDS
- Privia Medical Group- North Texas - Stephenville - Javara - PPDS
- DM Clinical Research - Sugarland - ERN - PPDS
- Mt. Olympus Medical Research Group, LLC
- DM Clinical Research - ERN - PPDS
- Cope Family Medicine - CCT - PPDS
- Ogden Clinic - Mountain View - CCT - PPDS
- Ogden Clinic - Grandview - CCT - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City
- JBR Clinical Research - CenExel JBR - PPDS
- Velocity Clinical Research
- Velocity Clinical Research - Family Practice - Portsmouth - PPDS
- Wenatchee Valley Hospital & Clinics Campus
- Centricity Research - New Minas - HyperCore - PPDS
- Colchester Research Group
- Mirtorabi Medicine Professional Corp
- Centricity Research - Bayview - HyperCore - PPDS
- Centricity Research - Toronto - HyperCore - PPDS
- Centricity Research - Quebec - HyperCore - PPDS
- Centricity Research - Mirabel - HyperCore - PPDS
- Centricity Research - Montreal - HyperCore - PPDS
- Diex Recherche - Joliette - PPDS
- Diex Recherche - Trois Rivieres - PPDS
- Diex Recherche - Victoriaville - PPDS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Cohort A1: mRNA-1083 and Placebo
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
Cohort B1: mRNA-1083 and Placebo
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1.
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.
Participants of age 50 to <65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1.
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.