Trials Today

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

Arm	Description	Assigned 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, Alabama 35216

Cullman Clinical Trials
Cullman, Alabama 35055

AMR Clinical Mobile
Mobile, Alabama 36608

Velocity Clinical Research, Mobile
Mobile, Alabama 36608

Lenzmeier Family Medicine - Avacare
Glendale, Arizona 85308

Desert Clinical Research
Mesa, Arizona 85213

Velocity Clinical Research - Phoenix
Phoenix, Arizona 85006

Foothills Research Center/Avacare
Phoenix, Arizona 85044

Headlands Research Scottsdale
Scottsdale, Arizona 85260

Fiel Family and Sports Medicine / Avacare
Tempe, Arizona 85283

Avacare
Colton, California 92324

CenExel CNR
Garden Grove, California 92845

Velocity Clinical Research, Huntington Park
Huntington Park, California 90255

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

Artemis Institute for Clinical Research
Riverside, California 92503

Peninsula Research Associates
Rolling Hills Estates, California 90274

Velocity Clinical Research -- Banning
San Bernardino, California 92408

Artemis Institute for Clinical Research
San Diego, California 92103

Tekton Research, LLC
Denver, Colorado 80238

Tekton Research, LLC
Fort Collins, Colorado 80525

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

Tekton Research, LLC
Longmont, Colorado 80501

New England Research Associates
Bridgeport, Connecticut 06606

Stamford Therapeutics Consortium
Stamford, Connecticut 06905

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

Hillcrest Medical Research, LLC
DeLand, Florida 32720

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

Suncoast Research Associates, LLC
Doral, Florida 33172

Velocity Clinical Research, Hallandale Beach
Hallandale, Florida 33009

Indago Research & Health Center, Inc
Hialeah, Florida 33012

CenExel Research Centers of America
Hollywood, Florida 33024

NextPhase Research Florida
Hollywood, Florida 33024

Health Awareness Inc.
Jupiter, Florida 33458

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

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

Accel Research Sites
Maitland, Florida 32751

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

Suncoast Clinical Research
New Port Richey, Florida 34652

Headlands Research Orlando
Orlando, Florida 32819

Innovation Medical Research Center
Palmetto Bay, Florida 33157

ForCare Clinical Research
Tampa, Florida 33613

Global Health Research Center, Inc.
Tampa, Florida 33615

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

DelRicht Research
Atlanta, Georgia 30329

Atlanta Center for Medical Research
Atlanta, Georgia 30331

Accel Research Sites - Neurostudies
Decatur, Georgia 30030

CenExel iResearch, LLC
Decatur, Georgia 30030

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

Velocity Clinical Research Savannah
Savannah, Georgia 31406

Clinical Research Atlanta
Stockbridge, Georgia 30281

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

DM Clinical Research - Melrose Park
Melrose Park, Illinois 60160

Velocity Clinical Research Valparaiso
Valparaiso, Indiana 46383

Velocity Clinical Research - Sioux City
Sioux City, Iowa 51106

Johnson County Clin-Trials
Lenexa, Kansas 66212

Tekton Research, LLC
Wichita, Kansas 67218

DelRicht Research
Louisville, Kentucky 40205

Versailles Family Medicine - CCT Research
Versailles, Kentucky 40383

Velocity Clinical Research-Baton Rouge
Baton Rouge, Louisiana 70809

Velocity Clinical Research - Covington
Covington, Louisiana 70433

Avacare
Kenner, Louisiana 70065

Velocity Clinical Research, Lafayette
Lafayette, Louisiana 70508

DelRicht Research
Mandeville, Louisiana 70471

DelRicht Research
New Orleans, Louisiana 70115

Velocity Clinical Research, New Orleans
New Orleans, Louisiana 70119

DelRicht Research
Prairieville, Louisiana 70769

Annapolis Internal Medicine
Annapolis, Maryland 21401

Centennial Medical Group
Columbia, Maryland 21045

Velocity Clinical Research, Rockville
Rockville, Maryland 20854

Brigham and Women's Hospital
Boston, Massachusetts 02115

DM Clinical Research - Brookline
Brookline, Massachusetts 02446

ActivMed Practices & Research, LLC
Methuen, Massachusetts 01844

Headlands Research Detroit
Southfield, Michigan 48034

DM Clinical Research - Southfield
Southfield, Michigan 48076

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

Velocity Clinical Research Gulfport
Gulfport, Mississippi 39503

Clinical Research Professionals
Chesterfield, Missouri 63005

AMR Clinical
Kansas City, Missouri 64116

Clay-Platte Family Medicine Clinic
Kansas City, Missouri 64151

DelRicht Research
Springfield, Missouri 65807

Sundance Clinical Research, LLC
St Louis, Missouri 63141

DelRicht Research
Town and Country, Missouri 63017

Avacare Research/Methodist Physicians Clinic
Fremont, Nebraska 68025

Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803

Velocity Clinical Research
Lincoln, Nebraska 68510

Velocity Clinical Research Norfolk
Norfolk, Nebraska 68701

Velocity Clinical Research Omaha
Omaha, Nebraska 68134

Avacare/Midwest Regional Health Services
Omaha, Nebraska 68144

Papillion Research/Avacare
Papillion, Nebraska 68046

Santa Rosa Medical Centers of Nevada
Las Vegas, Nevada 89119

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

DM Clinical Research - Albuquerque
Albuquerque, New Mexico 87106

Velocity Clinical Research - Albuquerque
Albuquerque, New Mexico 87107

Rochester Clinical Research
Rochester, New York 14609

Velocity Clinical Research, Durham
Durham, North Carolina 27701

Eximia Research - NC, LLC
Raleigh, North Carolina 27607

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

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

Velocity Clinical Research - Cleveland
Beachwood, Ohio 44122

CTI Clinical Research Center
Cincinnati, Ohio 45212

Velocity Clinical Research-Mt. Auburn
Cincinnati, Ohio 45242

Velocity Clinical Research Springdale
Cincinnati, Ohio 45246

Tekton Research, LLC
Edmond, Oklahoma 73013

Tekton Research, LLC
Moore, Oklahoma 73160

DelRicht Research
Tulsa, Oklahoma 74133

Tekton Research, LLC
Yukon, Oklahoma 73099

Velocity Clinical Research - Medford
Medford, Oregon 97504

Summit Headlands LLC
Portland, Oregon 97210

Hatboro Medical Associates/Avacare
Horsham, Pennsylvania 19044

DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania 19107

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

Velocity Clinical Research, Anderson
Anderson, South Carolina 29621

DelRicht Research
Charleston, South Carolina 29407

Velocity Clinical Research - Columbia
Columbia, South Carolina 29204

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

Velocity Clinical Research Spartanburg
Spartanburg, South Carolina 29303

Velocity Clinical Research Union
Union, South Carolina 29379

DelRicht Research
Hendersonville, Tennessee 37075

Velocity Clinical Research, Abilene
Abilene, Texas 79606

Tekton Research, LLC
Austin, Texas 78745

Velocity Clinical Research - Austin
Austin, Texas 78759

Tekton Research, LLC
Beaumont, Texas 77706

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

Velocity Clinical Research - Dallas
Dallas, Texas 75230

Avacare
Fort Worth, Texas 76135

DM Clinical Research - Houston
Houston, Texas 77065

DM Clinical Research - Houston
Houston, Texas 77081

DelRicht Research
Prosper, Texas 75078

Be Well Clinical Studies
Round Rock, Texas 78681

DM Clinical Research - San Antonio
San Antonio, Texas 78207

Tekton Research, LLC
San Antonio, Texas 78229

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

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

DM Clinical Research - Sugar Land
Sugar Land, Texas 77478

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

Olympus Clinical Research
Sugar Land, Texas 77479

DM Clinical Research - Tomball
Tomball, Texas 77375

Cope Family Medicine / Avacare
Bountiful, Utah 84010

Mountain View/Avacare
Pleasant View, Utah 84404

JBR Clinical Research
Salt Lake City, Utah 84107

Olympus Family Medicine/Avacare
Salt Lake City, Utah 84117

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

South Ogden Family Medicine/ Avacare
South Ogden, Utah 84405

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

Charlottesville Medical Research, LLC
Charlottesville, Virginia 22911

Velocity Clinical Research-Hampton
Hampton, Virginia 23666

Clinical Research Partners, LLC
Richmond, Virginia 23226

Velocity Clinical Research - Suffolk
Suffolk, Virginia 23435

Velocity Clinical Research, Spokane
Spokane, Washington 99218

More Details

NCT ID: NCT07266558
Status: Recruiting
Sponsor: ModernaTX, Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.