The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicityof mRNA-1083 as compared with active control, co-administered licensed influenza andsevere acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independentage-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthyadults 50 to
Not Provided
Biological: mRNA-1083
Suspension for injection
Biological: Placebo
0.9% sodium chloride suspension for injection
Biological: Influenza Vaccine
Commercially available formulation (Suspension for injection [pre-filled syringe])
Biological: COVID-19 Vaccine
Commercially available formulation (Suspension for injection)
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.
Pinnacle Research Group-409 E 10th St
Anniston 4830198, Alabama 4829764, United States
Accel Research Site - Achieve - Birmingham
Birmingham 4049979, Alabama 4829764, United States
Cullman Clinical Trials
Cullman 4057835, Alabama 4829764, United States
Desert Clinical Research - CCT - PPDS
Mesa 5304391, Arizona 5551752, United States
Foothills Research Center - CCT - PPDS
Phoenix 5308655, Arizona 5551752, United States
Headlands Research - Scottsdale - PPDS
Scottsdale 5313457, Arizona 5551752, United States
Scottsdale Clinical Trials
Scottsdale 5313457, Arizona 5551752, United States
Fiel Family & Sports Medicine - PC - CCT - PPDS
Tempe 5317058, Arizona 5551752, United States
AES - DRS - Synexus Clinical Research US, Inc. - Cerritos
Cerritos 5335663, California 5332921, United States
Long Beach Research Institute, LLC
Long Beach 5367929, California 5332921, United States
CenExel Apex (CNS) - Los Alamitos - PPDS
Los Alamitos 5368304, California 5332921, United States
Central Valley Research, LLC
Modesto 5373900, California 5332921, United States
Carbon Health- NoHo West Urgent Care and Primary Care
North Hollywood 5377654, California 5332921, United States
Empire Clinical Research
Pomona 5384170, California 5332921, United States
Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
Riverside 5387877, California 5332921, United States
Clinical Innovations Trials - Riverside - CenExel - PPDS
Riverside 5387877, California 5332921, United States
Peninsula Research Associates - Headlands - PPDS
Rolling Hills Estates 5388601, California 5332921, United States
Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
San Diego 5391811, California 5332921, United States
AES - DRS - Synexus Clinical Research US, Inc. - Vista
Vista 5406602, California 5332921, United States
Tekton Research - Fort Collins - PPDS
Fort Collins 5577147, Colorado 5417618, United States
Tekton Research - Longmont - PPDS
Longmont 5579276, Colorado 5417618, United States
Stamford Therapeutics Consortium - ERN - PPDS
Stamford 4843564, Connecticut 4831725, United States
Chase Medical Research LLC - Waterbury
Waterbury 4845193, Connecticut 4831725, United States
Revival Research Corporation
Doral 4153471, Florida 4155751, United States
Indago Research and Health Center
Hialeah 4158476, Florida 4155751, United States
CenExel RCA - Hollywood
Hollywood 4158928, Florida 4155751, United States
Nature Coast Clinical Research
Inverness 4159786, Florida 4155751, United States
Jacksonville Center For Clinical Research
Jacksonville 4160021, Florida 4155751, United States
Health Awareness - Jupiter - ERN - ERN
Jupiter 4160610, Florida 4155751, United States
Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS
Largo 4161580, Florida 4155751, United States
Flourish Research - Leesburg - PPDS
Leesburg 4161771, Florida 4155751, United States
Accel Research Sites - Maitland
Maitland 4163220, Florida 4155751, United States
AES - DRS - Optimal Research Florida - Melbourne
Melbourne 4163971, Florida 4155751, United States
Suncoast Research Group LLC - Flourish - PPDS
Miami 4164138, Florida 4155751, United States
St. Johns Center for Clinical Research - ERN - PPDS
Saint Augustine 4170894, Florida 4155751, United States
ForCare Clinical Research - CenExel FCR - PPDS
Tampa 4174757, Florida 4155751, United States
AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
Atlanta 4180439, Georgia 4197000, United States
DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS
Atlanta 4180439, Georgia 4197000, United States
iResearch Atlanta - CenExel - PPDS
Decatur 4191124, Georgia 4197000, United States
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
Fayetteville 4194474, Georgia 4197000, United States
Georgia Clinic - CCT - PPDS
Norcross 4212888, Georgia 4197000, United States
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah 4221552, Georgia 4197000, United States
Clinical Research Atlanta - ERN - PPDS
Stockbridge 4224681, Georgia 4197000, United States
AES - DRS - Synexus Clinical Research US, Inc. - Chicago
Chicago 4887398, Illinois 4896861, United States
Cedar Crosse Research Center
Chicago 4887398, Illinois 4896861, United States
Flourish Research - Andersonville - PPDS
Chicago 4887398, Illinois 4896861, United States
Koch Family Medicine
Morton 4902754, Illinois 4896861, United States
AES - DRS - Optimal Research Illinois - Peoria
Peoria 4905687, Illinois 4896861, United States
DM Clinical Research - Chicago - ERN - PPDS
River Forest 4907637, Illinois 4896861, United States
AES - DRS - Synexus Clinical Research US, Inc. - Evansville
Evansville 4257227, Indiana 4921868, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS
Valparaiso 4927537, Indiana 4921868, United States
The Iowa Clinic, P.C. - West Des Moines Campus
West Des Moines 4881346, Iowa 4862182, United States
Johnson County Clin-Trials
Lenexa 4274356, Kansas 4273857, United States
Delricht Overland Park
Overland Park 4276873, Kansas 4273857, United States
Tekton Research - Wichita - PPDS
Wichita 4281730, Kansas 4273857, United States
DelRicht Research, LLC - Louisville - PPDS
Louisville 4299276, Kentucky 6254925, United States
Versailles Family Medicine - CCT - PPDS
Versailles 4312057, Kentucky 6254925, United States
Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS
Baton Rouge 4315588, Louisiana 4331987, United States
Velocity Clinical Research - Covington - PPDS
Covington 4321005, Louisiana 4331987, United States
DelRicht Clinical Research, LLC - The Murphy Clinic - PPDS
Mandeville 4332455, Louisiana 4331987, United States
IMA Clinical Research - Monroe, LA - PPDS
Monroe 4333669, Louisiana 4331987, United States
DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS
New Orleans 4335045, Louisiana 4331987, United States
DelRicht Research, LLC - Internal - Baton Rouge - PPDS
Prairieville 4338012, Louisiana 4331987, United States
Annapolis Internal Medicine - CCT - PPDS
Annapolis 4347242, Maryland 4361885, United States
Advanced Primary Care & Geriatric Care - CCT - PPDS
Rockville 4367175, Maryland 4361885, United States
DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS
Rockville 4367175, Maryland 4361885, United States
Velocity Clinical Research (Rockville - Maryland) - PPDS
Rockville 4367175, Maryland 4361885, United States
Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS
Silver Spring 4369596, Maryland 4361885, United States
DM Clinical Research - The Brook House - ERN - PPDS
Brookline 4931482, Massachusetts 6254926, United States
Headlands Research - Detroit - Headlands - PPDS
Southfield 5010636, Michigan 5001836, United States
Great Lakes Research Institute
Southfield 5010636, Michigan 5001836, United States
DM Clinical Research - Southfield - ERN - PPDS
Southfield 5010636, Michigan 5001836, United States
Mankato Clinic - Premier Drive - Javara - PPDS
Mankato 5036420, Minnesota 5037779, United States
AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
Richfield 5043193, Minnesota 5037779, United States
DelRicht Research, LLC - Gulfport - PPDS
Gulfport 4428667, Mississippi 4436296, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
Creve Coeur 4382837, Missouri 4398678, United States
Clay Platte Family Medicine - CCT Research
Kansas City 4393217, Missouri 4398678, United States
Clinvest - National Ave - Headlands - PPDS
Springfield 4409896, Missouri 4398678, United States
DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS
Springfield 4409896, Missouri 4398678, United States
Sundance Clinical Research - ERN - PPDS
St Louis 4407066, Missouri 4398678, United States
DelRicht Clinical Research, LLC - MS. Medicine - PPDS
Town and Country 4411912, Missouri 4398678, United States
Skyline Medical Center - PC - CCT - PPDS
Elkhorn 5067545, Nebraska 5073708, United States
Methodist Physicians Clinic - CCT Research - PPDS
Fremont 5068725, Nebraska 5073708, United States
Velocity Clinical Research (Lincoln - Nebraska) - PPDS
Lincoln 5072006, Nebraska 5073708, United States
Velocity Clinical Research
Omaha 5074472, Nebraska 5073708, United States
Midwest Regional Health Services - LLC - CCT - PPDS
Omaha 5074472, Nebraska 5073708, United States
Papillion Research Center
Papillion 5074792, Nebraska 5073708, United States
AES - DRS - Synexus Clinical Research US, Inc. - Henderson
Henderson 5505411, Nevada 5509151, United States
Santa Rosa Urgent Care - Primary Care - CCT - PPDS
Las Vegas 5506956, Nevada 5509151, United States
Las Vegas Clinical Trials
North Las Vegas 5509403, Nevada 5509151, United States
Hassman Research Institute - HRI - Berlin - CenExel - PPDS
Berlin 4500771, New Jersey 5101760, United States
Velocity Clinical Research - Albuquerque - PPDS
Albuquerque 5454711, New Mexico 5481136, United States
AXCES Research Group - Sante Fe - ERN - PPDS
Santa Fe 5490263, New Mexico 5481136, United States
DM Clinical Research - Brooklyn
Brooklyn 5110302, New York 5128638, United States
AES - DRS - Synexus Clinical Research US, Inc. - New York
New York 5128581, New York 5128638, United States
Rochester Clinical Research, Inc
Rochester 5134086, New York 5128638, United States
DelRicht Research, LLC - Charlotte - PPDS
Charlotte 4460243, North Carolina 4482348, United States
Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS
Charlotte 4460243, North Carolina 4482348, United States
Monroe Biomedical Research -343 Venus St
Monroe 4479946, North Carolina 4482348, United States
Trial Management Associates LLC - ERN - PPDS
Wilmington 4499379, North Carolina 4482348, United States
CTI Clinical Research Center - PPDS
Cincinnati 4508722, Ohio 5165418, United States
Velocity Clinical Research (Cincinnati - Ohio) - PPDS
Cincinnati 4508722, Ohio 5165418, United States
AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati 4508722, Ohio 5165418, United States
Velocity Clinical Research (Cincinnati - Ohio) - PPDS
Cincinnati 4508722, Ohio 5165418, United States
AES - DRS - Synexus Clinical Research US, Inc. - Columbus
Columbus 4509177, Ohio 5165418, United States
WellNow Urgent Care & Research - Huber Heights
Huber Heights 4514746, Ohio 5165418, United States
Tekton Research - Edmond - PPDS
Edmond 4535740, Oklahoma 4544379, United States
Lynn Institute of East Oklahoma - ERN - PPDS
Oklahoma City 4544349, Oklahoma 4544379, United States
DelRicht Research, LLC - Internal - Tulsa - PPDS
Tulsa 4553433, Oklahoma 4544379, United States
Tekton Research - Yukon - PPDS
Yukon 4556165, Oklahoma 4544379, United States
The Corvallis Clinic, PC - 3680 NW Samaritan Drive
Corvallis 5720727, Oregon 5744337, United States
Hatboro Medical Associates - CCT - PPDS
Hatboro 5192863, Pennsylvania 6254927, United States
DM Clinical Research - Philadelphia - ERN - PPDS
Philadelphia 4560349, Pennsylvania 6254927, United States
AES - DRS - Synexus Clinical Research US, Inc. - Anderson
Anderson 4569298, South Carolina 4597040, United States
TMA - Myrtle Beach - ERN - PPDS
Myrtle Beach 4588718, South Carolina 4597040, United States
Velocity Clinical Research - Spartanburg - PPDS
Spartanburg 4597200, South Carolina 4597040, United States
DelRicht Research, LLC - Hendersonville - PPDS
Hendersonville 4628735, Tennessee 4662168, United States
AES - DRS - Optimal Research Texas - Austin
Austin 4671654, Texas 4736286, United States
Benchmark Research - Austin - HyperCore - PPDS
Austin 4671654, Texas 4736286, United States
Tekton Research - Austin - PPDS
Austin 4671654, Texas 4736286, United States
Tekton Research Inc
Beaumont 4672989, Texas 4736286, United States
Headlands Research - Brownsville - Headlands - PPDS
Brownsville 4676740, Texas 4736286, United States
AES - DRS - Synexus Clinical Research US, Inc. - Dallas
Dallas 4684888, Texas 4736286, United States
3A Research, LLC
El Paso 5520993, Texas 4736286, United States
Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS
Fort Worth 4691930, Texas 4736286, United States
Mount Olympus Medical Research Group - ClinEdge - PPDS
Friendswood 4692521, Texas 4736286, United States
DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS
Houston 4699066, Texas 4736286, United States
DM Clinical Research - Bellaire - ERN - PPDS
Houston 4699066, Texas 4736286, United States
DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
Humble 4699442, Texas 4736286, United States
DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS
McKinney 4710178, Texas 4736286, United States
Benchmark Research - San Angelo - HyperCore - PPDS
San Angelo 5530022, Texas 4736286, United States
Sun Research Institute -427 9th St
San Antonio 4726206, Texas 4736286, United States
Clinical Trials of Texas, Inc. - PPDS
San Antonio 4726206, Texas 4736286, United States
IMA Clinical Research - San Antonio - PPDS
San Antonio 4726206, Texas 4736286, United States
Tekton Research - San Antonio - PPDS
San Antonio 4726206, Texas 4736286, United States
Privia Medical Group Gulf Coast, PLLC - San Marcos - Javara - PPDS
San Marcos 4726491, Texas 4736286, United States
Privia Medical Group- North Texas - Stephenville - Javara - PPDS
Stephenville 4734350, Texas 4736286, United States
DM Clinical Research - Sugarland - ERN - PPDS
Sugar Land 4734825, Texas 4736286, United States
DM Clinical Research - ERN - PPDS
Tomball 4737094, Texas 4736286, United States
Cope Family Medicine - CCT - PPDS
Bountiful 5771826, Utah 5549030, United States
Ogden Clinic - Mountain View - CCT - PPDS
Pleasant View 5779833, Utah 5549030, United States
Ogden Clinic - Grandview - CCT - PPDS
Roy 5780802, Utah 5549030, United States
JBR Clinical Research - CenExel JBR - PPDS
Salt Lake City 5780993, Utah 5549030, United States
AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City
South Salt Lake 5781794, Utah 5549030, United States
Velocity Clinical Research - Family Practice - Portsmouth - PPDS
Portsmouth 4779999, Virginia 6254928, United States
Wenatchee Valley Hospital & Clinics Campus
Wenatchee 5815342, Washington 5815135, United States
Not Provided