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)
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
64 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection — Day 1 through Day 181 The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).
Vaccine Efficacy (VE) of mRNA-1283 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection — Day 1 through Day 181 The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).
Number of Participants with Unsolicited Adverse Events (AEs) — Day 1 through Day 28
Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation — Day 1 through Day 181
Trial sites (150)
Facility
City
Region
Status
Accel Clinical Research
Birmingham
Alabama
Cullman Clinical Trials
Cullman
Alabama
AMR Clinical Mobile
Mobile
Alabama
Velocity Clinical Research, Mobile
Mobile
Alabama
Lenzmeier Family Medicine - Avacare
Glendale
Arizona
Desert Clinical Research
Mesa
Arizona
Velocity Clinical Research - Phoenix
Phoenix
Arizona
Foothills Research Center/Avacare
Phoenix
Arizona
Headlands Research Scottsdale
Scottsdale
Arizona
Fiel Family and Sports Medicine / Avacare
Tempe
Arizona
Avacare
Colton
California
CenExel CNR
Garden Grove
California
Velocity Clinical Research, Huntington Park
Huntington Park
California
Velocity Clinical Research - San Diego - ERN - PPDS-Site Number:8400010
La Mesa
California
Velocity Clinical Research - Los Angeles
Los Angeles
California
Artemis Institute for Clinical Research
Riverside
California
Peninsula Research Associates
Rolling Hills Estates
California
Velocity Clinical Research -- Banning
San Bernardino
California
Artemis Institute for Clinical Research
San Diego
California
Tekton Research, LLC
Denver
Colorado
Tekton Research, LLC
Fort Collins
Colorado
Critical Care, Pulmonary and Sleep Associates, P.LLP/Avacare
Lakewood
Colorado
Tekton Research, LLC
Longmont
Colorado
New England Research Associates
Bridgeport
Connecticut
Stamford Therapeutics Consortium
Stamford
Connecticut
Velocity Clinical Research-Washington, DC
Washington D.C.
District of Columbia
Hillcrest Medical Research, LLC
DeLand
Florida
University Clinical Research-Deland, LLC d/b/a Accel Research Sites - Deland Clinical Research Unit
DeLand
Florida
Suncoast Research Associates, LLC
Doral
Florida
Velocity Clinical Research, Hallandale Beach
Hallandale
Florida
Indago Research & Health Center, Inc
Hialeah
Florida
CenExel Research Centers of America
Hollywood
Florida
NextPhase Research Florida
Hollywood
Florida
Health Awareness Inc.
Jupiter
Florida
Sandhill Research, LLC d/b/a Accel Research Sites - Lakeland Clinical Research Unit
Lakeland
Florida
Sandhill Research, LLC d/b/a Accel Research Sites- St. Pete-Largo Clinical Research Unit
Largo
Florida
Accel Research Sites
Maitland
Florida
Global Health Research Center, Inc.
Miami Lakes
Florida
Suncoast Clinical Research
New Port Richey
Florida
Headlands Research Orlando
Orlando
Florida
+ 110 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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