A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)

Purpose

The purpose of this study is to evaluate the efficacy and safety of mRNA-1283 and mRNA-1273 (variant formulations) in adults 50 to 64 years of age without high risk factors for severe COVID-19.

Condition

  • SARS-CoV-2

Eligibility

Eligible Ages
Between 50 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy and without underlying medical conditions that may put them at higher risk of experiencing severe outcomes of COVID-19, as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Exclusion Criteria

  • History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment. - Acutely ill or febrile within 72 hours prior to or at the Screening Visit or Day 1. - Receipt of any of the following: - COVID-19 vaccine within 3 months prior to enrollment, - Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention, - Corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study or, - Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. - Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study injection. - Has participated in an investigational clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
mRNA-1273 (Variant Formulation) 		Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.
  • Biological: mRNA-1273
    Sterile liquid for injection
Experimental
mRNA-1283 (Variant Formulation) 		Participants will receive a single IM injection of mRNA-1283 on Day 1.
  • Biological: mRNA-1283
    Sterile liquid for injection
Placebo Comparator
Placebo 		Participants will receive a single IM injection of placebo on Day 1.
  • Biological: Placebo
    0.9% sodium chloride (normal saline) injection

Recruiting Locations

Accel Clinical Research
Birmingham 4049979, Alabama 4829764 35216

Cullman Clinical Trials
Cullman 4057835, Alabama 4829764 35055

AMR Clinical Mobile
Mobile 4076598, Alabama 4829764 36608

Velocity Clinical Research, Mobile
Mobile 4076598, Alabama 4829764 36608

Lenzmeier Family Medicine - Avacare
Glendale 5295985, Arizona 5551752 85308

Desert Clinical Research
Mesa 5304391, Arizona 5551752 85213

Velocity Clinical Research - Phoenix
Phoenix 5308655, Arizona 5551752 85006

Foothills Research Center/Avacare
Phoenix 5308655, Arizona 5551752 85044

Headlands Research Scottsdale
Scottsdale 5313457, Arizona 5551752 85260

Fiel Family and Sports Medicine / Avacare
Tempe 5317058, Arizona 5551752 85283

Avacare
Colton 5338783, California 5332921 92324

CenExel CNR
Garden Grove 5351515, California 5332921 92845

Velocity Clinical Research, Huntington Park
Huntington Park 5358736, California 5332921 90255

Velocity Clinical Research - San Diego - ERN - PPDS-Site Number:8400010
La Mesa 5363990, California 5332921 91942

Velocity Clinical Research - Los Angeles
Los Angeles 5368361, California 5332921 90017

Artemis Institute for Clinical Research
Riverside 5387877, California 5332921 92503

Peninsula Research Associates
Rolling Hills Estates 5388601, California 5332921 90274

Velocity Clinical Research -- Banning
San Bernardino 5391710, California 5332921 92408

Artemis Institute for Clinical Research
San Diego 5391811, California 5332921 92103

Tekton Research, LLC
Denver 5419384, Colorado 5417618 80238

Tekton Research, LLC
Fort Collins 5577147, Colorado 5417618 80525

Critical Care, Pulmonary and Sleep Associates, P.LLP/Avacare
Lakewood 5427946, Colorado 5417618 80228

Tekton Research, LLC
Longmont 5579276, Colorado 5417618 80501

New England Research Associates
Bridgeport 5282804, Connecticut 4831725 06606

Stamford Therapeutics Consortium
Stamford 4843564, Connecticut 4831725 06905

Velocity Clinical Research-Washington, DC
Washington D.C. 4140963, District of Columbia 4138106 20016

Hillcrest Medical Research, LLC
DeLand 4152890, Florida 4155751 32720

University Clinical Research-Deland, LLC d/b/a Accel Research Sites - Deland Clinical Research Unit
DeLand 4152890, Florida 4155751 32720

Suncoast Research Associates, LLC
Doral 4153471, Florida 4155751 33172

Velocity Clinical Research, Hallandale Beach
Hallandale 4157898, Florida 4155751 33009

Indago Research & Health Center, Inc
Hialeah 4158476, Florida 4155751 33012

CenExel Research Centers of America
Hollywood 4158928, Florida 4155751 33024

NextPhase Research Florida
Hollywood 4158928, Florida 4155751 33024

Health Awareness Inc.
Jupiter 4160610, Florida 4155751 33458

Sandhill Research, LLC d/b/a Accel Research Sites - Lakeland Clinical Research Unit
Lakeland 4161438, Florida 4155751 33803

Sandhill Research, LLC d/b/a Accel Research Sites- St. Pete-Largo Clinical Research Unit
Largo 4161580, Florida 4155751 33777

Accel Research Sites
Maitland 4163220, Florida 4155751 32751

Global Health Research Center, Inc.
Miami Lakes 4164186, Florida 4155751 33016

Suncoast Clinical Research
New Port Richey 4165869, Florida 4155751 34652

Headlands Research Orlando
Orlando 4167147, Florida 4155751 32819

Innovation Medical Research Center
Palmetto Bay 4167634, Florida 4155751 33157

ForCare Clinical Research
Tampa 4174757, Florida 4155751 33613

Global Health Research Center, Inc.
Tampa 4174757, Florida 4155751 33615

Javara Inc. and PRIVIA Medical Group of Georgia, LLC
Albany 4179320, Georgia 4197000 31707

DelRicht Research
Atlanta 4180439, Georgia 4197000 30329

Atlanta Center for Medical Research
Atlanta 4180439, Georgia 4197000 30331

Accel Research Sites - Neurostudies
Decatur 4191124, Georgia 4197000 30030

CenExel iResearch, LLC
Decatur 4191124, Georgia 4197000 30030

Javara Inc. and Privia Medical Group of Georgia, LLC
Fayetteville 4194474, Georgia 4197000 30214

Velocity Clinical Research Savannah
Savannah 4221552, Georgia 4197000 31406

Clinical Research Atlanta
Stockbridge 4224681, Georgia 4197000 30281

Velocity Clinical Research - Boise - ERN - PPDS
Meridian 5600685, Idaho 5596512 83642

DM Clinical Research - Melrose Park
Melrose Park 4901868, Illinois 4896861 60160

Velocity Clinical Research Valparaiso
Valparaiso 4927537, Indiana 4921868 46383

Velocity Clinical Research - Sioux City
Sioux City 4876523, Iowa 4862182 51106

Johnson County Clin-Trials
Lenexa 4274356, Kansas 4273857 66212

Tekton Research, LLC
Wichita 4281730, Kansas 4273857 67218

DelRicht Research
Louisville 4299276, Kentucky 6254925 40205

Versailles Family Medicine - CCT Research
Versailles 4312057, Kentucky 6254925 40383

Velocity Clinical Research-Baton Rouge
Baton Rouge 4315588, Louisiana 4331987 70809

Velocity Clinical Research - Covington
Covington 4321005, Louisiana 4331987 70433

Avacare
Kenner 4329753, Louisiana 4331987 70065

Velocity Clinical Research, Lafayette
Lafayette 4330145, Louisiana 4331987 70508

DelRicht Research
Mandeville 4332455, Louisiana 4331987 70471

DelRicht Research
New Orleans 4335045, Louisiana 4331987 70115

Velocity Clinical Research, New Orleans
New Orleans 4335045, Louisiana 4331987 70119

DelRicht Research
Prairieville 4338012, Louisiana 4331987 70769

Annapolis Internal Medicine
Annapolis 4347242, Maryland 4361885 21401

Centennial Medical Group
Columbia 4352053, Maryland 4361885 21045

Velocity Clinical Research, Rockville
Rockville 4367175, Maryland 4361885 20854

ActivMed Practices & Research, LLC
Methuen 4943828, Massachusetts 6254926 01844

Headlands Research Detroit
Southfield 5010636, Michigan 5001836 48034

DM Clinical Research - Southfield
Southfield 5010636, Michigan 5001836 48076

Javara Inc. and Mankato Clinic, Ltd.
Mankato 5036420, Minnesota 5037779 56001

Velocity Clinical Research Gulfport
Gulfport 4428667, Mississippi 4436296 39503

Clinical Research Professionals
Chesterfield 4381072, Missouri 4398678 63005

AMR Clinical
Kansas City 4393217, Missouri 4398678 64116

Clay-Platte Family Medicine Clinic
Kansas City 4393217, Missouri 4398678 64151

DelRicht Research
Springfield 4409896, Missouri 4398678 65807

Sundance Clinical Research, LLC
St Louis 4407066, Missouri 4398678 63141

DelRicht Research
Town and Country 4411912, Missouri 4398678 63017

Avacare Research/Methodist Physicians Clinic
Fremont 5068725, Nebraska 5073708 68025

Velocity Clinical Research, Grand Island
Grand Island 5069297, Nebraska 5073708 68803

Velocity Clinical Research
Lincoln 5072006, Nebraska 5073708 68510

Velocity Clinical Research Norfolk
Norfolk 5073965, Nebraska 5073708 68701

Velocity Clinical Research Omaha
Omaha 5074472, Nebraska 5073708 68134

Avacare/Midwest Regional Health Services
Omaha 5074472, Nebraska 5073708 68144

Papillion Research/Avacare
Papillion 5074792, Nebraska 5073708 68046

Santa Rosa Medical Centers of Nevada
Las Vegas 5506956, Nevada 5509151 89119

DM Clinical Research - Jersey City
Jersey City 5099836, New Jersey 5101760 07306

DM Clinical Research - Albuquerque
Albuquerque 5454711, New Mexico 5481136 87106

Velocity Clinical Research - Albuquerque
Albuquerque 5454711, New Mexico 5481136 87107

Rochester Clinical Research
Rochester 5134086, New York 5128638 14609

Velocity Clinical Research, Durham
Durham 4464368, North Carolina 4482348 27701

Eximia Research - NC, LLC
Raleigh 4487042, North Carolina 4482348 27607

TMA Headlands LLC d/b/a Trial Management Associates
Wilmington 4499379, North Carolina 4482348 28403

Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348 27157

Velocity Clinical Research - Cleveland
Beachwood 5146711, Ohio 5165418 44122

CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418 45212

Velocity Clinical Research-Mt. Auburn
Cincinnati 4508722, Ohio 5165418 45242

Velocity Clinical Research Springdale
Cincinnati 4508722, Ohio 5165418 45246

Tekton Research, LLC
Edmond 4535740, Oklahoma 4544379 73013

Tekton Research, LLC
Moore 4542975, Oklahoma 4544379 73160

DelRicht Research
Tulsa 4553433, Oklahoma 4544379 74133

Tekton Research, LLC
Yukon 4556165, Oklahoma 4544379 73099

Velocity Clinical Research - Medford
Medford 5740099, Oregon 5744337 97504

Summit Headlands LLC
Portland 5746545, Oregon 5744337 97210

Hatboro Medical Associates/Avacare
Horsham 5194302, Pennsylvania 6254927 19044

DM Clinical Research - Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19107

Velocity Clinical Research - East Greenwich
East Greenwich 5221875, Rhode Island 5224323 02818

Velocity Clinical Research, Anderson
Anderson 4569298, South Carolina 4597040 29621

DelRicht Research
Charleston 4574324, South Carolina 4597040 29407

Velocity Clinical Research - Columbia
Columbia 4575352, South Carolina 4597040 29204

Coastal Carolina Research Center, LLC
North Charleston 4589387, South Carolina 4597040 29405

Velocity Clinical Research Spartanburg
Spartanburg 4597200, South Carolina 4597040 29303

Velocity Clinical Research Union
Union 4599214, South Carolina 4597040 29379

DelRicht Research
Hendersonville 4628735, Tennessee 4662168 37075

Velocity Clinical Research, Abilene
Abilene 4669635, Texas 4736286 79606

Tekton Research, LLC
Austin 4671654, Texas 4736286 78745

Velocity Clinical Research - Austin
Austin 4671654, Texas 4736286 78759

Tekton Research, LLC
Beaumont 4672989, Texas 4736286 77706

Javara Inc. and Privia Medical Group Gulf Coast, PLLC
Conroe 4682991, Texas 4736286 77384

Velocity Clinical Research - Dallas
Dallas 4684888, Texas 4736286 75230

Avacare
Fort Worth 4691930, Texas 4736286 76135

DM Clinical Research - Houston
Houston 4699066, Texas 4736286 77065

DM Clinical Research - Houston
Houston 4699066, Texas 4736286 77081

DelRicht Research
Prosper 4720833, Texas 4736286 75078

Be Well Clinical Studies
Round Rock 4724129, Texas 4736286 78681

DM Clinical Research - San Antonio
San Antonio 4726206, Texas 4736286 78207

Tekton Research, LLC
San Antonio 4726206, Texas 4736286 78229

Javara Inc. and Privia Medical Group Gulf Coast, PLLC
San Marcos 4726491, Texas 4736286 78666

Javara Inc. and Privia Medical Group - North Texas
Stephenville 4734350, Texas 4736286 76401

DM Clinical Research - Sugar Land
Sugar Land 4734825, Texas 4736286 77478

Javara Inc. and Privia Medical Group Gulf Coast, PLLC
Sugar Land 4734825, Texas 4736286 77478

Olympus Clinical Research
Sugar Land 4734825, Texas 4736286 77479

DM Clinical Research - Tomball
Tomball 4737094, Texas 4736286 77375

Cope Family Medicine / Avacare
Bountiful 5771826, Utah 5549030 84010

Mountain View/Avacare
Pleasant View 5779833, Utah 5549030 84404

JBR Clinical Research
Salt Lake City 5780993, Utah 5549030 84107

Olympus Family Medicine/Avacare
Salt Lake City 5780993, Utah 5549030 84117

J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan 5781770, Utah 5549030 84095

South Ogden Family Medicine/ Avacare
South Ogden 5781783, Utah 5549030 84405

Velocity Clinical Research - Salt Lake City (West Jordan)
West Jordan 5784549, Utah 5549030 84088

Charlottesville Medical Research, LLC
Charlottesville 4752031, Virginia 6254928 22911

Velocity Clinical Research-Hampton
Hampton 4762894, Virginia 6254928 23666

Clinical Research Partners, LLC
Richmond 4781708, Virginia 6254928 23226

Velocity Clinical Research - Suffolk
Suffolk 4788158, Virginia 6254928 23435

Velocity Clinical Research, Spokane
Spokane 5811696, Washington 5815135 99218

More Details

NCT ID
NCT07266558
Status
Recruiting
Sponsor
ModernaTX, Inc.

Study Contact

Moderna WeCare Team
+1-866-663-3762
WeCareClinicalTrials@modernatx.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center