Official Title
A Phase 4, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of mRNA-1283 And mRNA-1273 Variant-Containing Formulation in Adults 50 to 64 Years of Age Without Underlying Conditions That Put Them at High Risk for Severe Outcomes From COVID-19
Brief Summary

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

Detailed Description

Not Provided

Recruiting
SARS-CoV-2

Biological: mRNA-1273

Sterile liquid for injection

Biological: mRNA-1283

Sterile liquid for injection

Biological: Placebo

0.9% sodium chloride (normal saline) injection

Eligibility Criteria

Key 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.

Key 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.

Eligibility Gender
All
Eligibility Age
Minimum: 50 Years ~ Maximum: 64 Years
Countries
United States
Locations

Accel Clinical Research
Birmingham, Alabama, United States

Cullman Clinical Trials
Cullman, Alabama, United States

AMR Clinical Mobile
Mobile, Alabama, United States

Velocity Clinical Research, Mobile
Mobile, Alabama, United States

Lenzmeier Family Medicine - Avacare
Glendale, Arizona, United States

Desert Clinical Research
Mesa, Arizona, United States

Velocity Clinical Research - Phoenix
Phoenix, Arizona, United States

Foothills Research Center/Avacare
Phoenix, Arizona, United States

Headlands Research Scottsdale
Scottsdale, Arizona, United States

Fiel Family and Sports Medicine / Avacare
Tempe, Arizona, United States

Avacare
Colton, California, United States

CenExel CNR
Garden Grove, California, United States

Velocity Clinical Research, Huntington Park
Huntington Park, California, United States

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

Velocity Clinical Research - Los Angeles
Los Angeles, California, United States

Artemis Institute for Clinical Research
Riverside, California, United States

Peninsula Research Associates
Rolling Hills Estates, California, United States

Velocity Clinical Research -- Banning
San Bernardino, California, United States

Artemis Institute for Clinical Research
San Diego, California, United States

Tekton Research, LLC
Denver, Colorado, United States

Tekton Research, LLC
Fort Collins, Colorado, United States

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

Tekton Research, LLC
Longmont, Colorado, United States

New England Research Associates
Bridgeport, Connecticut, United States

Stamford Therapeutics Consortium
Stamford, Connecticut, United States

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

Hillcrest Medical Research, LLC
DeLand, Florida, United States

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

Suncoast Research Associates, LLC
Doral, Florida, United States

Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States

Indago Research & Health Center, Inc
Hialeah, Florida, United States

CenExel Research Centers of America
Hollywood, Florida, United States

NextPhase Research Florida
Hollywood, Florida, United States

Health Awareness Inc.
Jupiter, Florida, United States

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

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

Accel Research Sites
Maitland, Florida, United States

Global Health Research Center, Inc.
Miami Lakes, Florida, United States

Suncoast Clinical Research
New Port Richey, Florida, United States

Headlands Research Orlando
Orlando, Florida, United States

Innovation Medical Research Center
Palmetto Bay, Florida, United States

ForCare Clinical Research
Tampa, Florida, United States

Global Health Research Center, Inc.
Tampa, Florida, United States

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

DelRicht Research
Atlanta, Georgia, United States

Atlanta Center for Medical Research
Atlanta, Georgia, United States

Accel Research Sites - Neurostudies
Decatur, Georgia, United States

CenExel iResearch, LLC
Decatur, Georgia, United States

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

Velocity Clinical Research Savannah
Savannah, Georgia, United States

Clinical Research Atlanta
Stockbridge, Georgia, United States

Velocity Clinical Research - Boise - ERN - PPDS
Meridian, Idaho, United States

DM Clinical Research - Melrose Park
Melrose Park, Illinois, United States

Velocity Clinical Research Valparaiso
Valparaiso, Indiana, United States

Velocity Clinical Research - Sioux City
Sioux City, Iowa, United States

Johnson County Clin-Trials
Lenexa, Kansas, United States

Tekton Research, LLC
Wichita, Kansas, United States

DelRicht Research
Louisville, Kentucky, United States

Versailles Family Medicine - CCT Research
Versailles, Kentucky, United States

Velocity Clinical Research-Baton Rouge
Baton Rouge, Louisiana, United States

Velocity Clinical Research - Covington
Covington, Louisiana, United States

Avacare
Kenner, Louisiana, United States

Velocity Clinical Research, Lafayette
Lafayette, Louisiana, United States

DelRicht Research
Mandeville, Louisiana, United States

DelRicht Research
New Orleans, Louisiana, United States

Velocity Clinical Research, New Orleans
New Orleans, Louisiana, United States

DelRicht Research
Prairieville, Louisiana, United States

Annapolis Internal Medicine
Annapolis, Maryland, United States

Centennial Medical Group
Columbia, Maryland, United States

Velocity Clinical Research, Rockville
Rockville, Maryland, United States

Brigham and Women's Hospital
Boston, Massachusetts, United States

DM Clinical Research - Brookline
Brookline, Massachusetts, United States

ActivMed Practices & Research, LLC
Methuen, Massachusetts, United States

Headlands Research Detroit
Southfield, Michigan, United States

DM Clinical Research - Southfield
Southfield, Michigan, United States

Javara Inc. and Mankato Clinic, Ltd.
Mankato, Minnesota, United States

Velocity Clinical Research Gulfport
Gulfport, Mississippi, United States

Clinical Research Professionals
Chesterfield, Missouri, United States

AMR Clinical
Kansas City, Missouri, United States

Clay-Platte Family Medicine Clinic
Kansas City, Missouri, United States

DelRicht Research
Springfield, Missouri, United States

Sundance Clinical Research, LLC
St Louis, Missouri, United States

DelRicht Research
Town and Country, Missouri, United States

Avacare Research/Methodist Physicians Clinic
Fremont, Nebraska, United States

Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States

Velocity Clinical Research
Lincoln, Nebraska, United States

Velocity Clinical Research Norfolk
Norfolk, Nebraska, United States

Velocity Clinical Research Omaha
Omaha, Nebraska, United States

Avacare/Midwest Regional Health Services
Omaha, Nebraska, United States

Papillion Research/Avacare
Papillion, Nebraska, United States

Santa Rosa Medical Centers of Nevada
Las Vegas, Nevada, United States

DM Clinical Research - Jersey City
Jersey City, New Jersey, United States

DM Clinical Research - Albuquerque
Albuquerque, New Mexico, United States

Velocity Clinical Research - Albuquerque
Albuquerque, New Mexico, United States

Rochester Clinical Research
Rochester, New York, United States

Velocity Clinical Research, Durham
Durham, North Carolina, United States

Eximia Research - NC, LLC
Raleigh, North Carolina, United States

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

Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States

Velocity Clinical Research - Cleveland
Beachwood, Ohio, United States

CTI Clinical Research Center
Cincinnati, Ohio, United States

Velocity Clinical Research-Mt. Auburn
Cincinnati, Ohio, United States

Velocity Clinical Research Springdale
Cincinnati, Ohio, United States

Tekton Research, LLC
Edmond, Oklahoma, United States

Tekton Research, LLC
Moore, Oklahoma, United States

DelRicht Research
Tulsa, Oklahoma, United States

Tekton Research, LLC
Yukon, Oklahoma, United States

Velocity Clinical Research - Medford
Medford, Oregon, United States

Summit Headlands LLC
Portland, Oregon, United States

Hatboro Medical Associates/Avacare
Horsham, Pennsylvania, United States

DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States

Velocity Clinical Research - East Greenwich
East Greenwich, Rhode Island, United States

Velocity Clinical Research, Anderson
Anderson, South Carolina, United States

DelRicht Research
Charleston, South Carolina, United States

Velocity Clinical Research - Columbia
Columbia, South Carolina, United States

Coastal Carolina Research Center, LLC
North Charleston, South Carolina, United States

Velocity Clinical Research Spartanburg
Spartanburg, South Carolina, United States

Velocity Clinical Research Union
Union, South Carolina, United States

DelRicht Research
Hendersonville, Tennessee, United States

Velocity Clinical Research, Abilene
Abilene, Texas, United States

Tekton Research, LLC
Austin, Texas, United States

Velocity Clinical Research - Austin
Austin, Texas, United States

Tekton Research, LLC
Beaumont, Texas, United States

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

Velocity Clinical Research - Dallas
Dallas, Texas, United States

Avacare
Fort Worth, Texas, United States

DM Clinical Research - Houston
Houston, Texas, United States

DM Clinical Research - Houston
Houston, Texas, United States

DelRicht Research
Prosper, Texas, United States

Be Well Clinical Studies
Round Rock, Texas, United States

DM Clinical Research - San Antonio
San Antonio, Texas, United States

Tekton Research, LLC
San Antonio, Texas, United States

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

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

DM Clinical Research - Sugar Land
Sugar Land, Texas, United States

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

Olympus Clinical Research
Sugar Land, Texas, United States

DM Clinical Research - Tomball
Tomball, Texas, United States

Cope Family Medicine / Avacare
Bountiful, Utah, United States

Mountain View/Avacare
Pleasant View, Utah, United States

JBR Clinical Research
Salt Lake City, Utah, United States

Olympus Family Medicine/Avacare
Salt Lake City, Utah, United States

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

South Ogden Family Medicine/ Avacare
South Ogden, Utah, United States

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

Charlottesville Medical Research, LLC
Charlottesville, Virginia, United States

Velocity Clinical Research-Hampton
Hampton, Virginia, United States

Clinical Research Partners, LLC
Richmond, Virginia, United States

Velocity Clinical Research - Suffolk
Suffolk, Virginia, United States

Velocity Clinical Research, Spokane
Spokane, Washington, United States

Contacts

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

Not Provided

ModernaTX, Inc.
NCT Number
Keywords
mRNA-1273
mRNA-1283
SARS-CoV-2
mRNA Vaccine
Coronavirus
Messenger RNA
Covid-19
COVID-19 vaccine
Moderna
MeSH Terms
Coronavirus Infections
COVID-19
2019-nCoV Vaccine mRNA-1273