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RECRUITINGPhase 4INTERVENTIONAL

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)

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

mRNA-1273

Sterile liquid for injection

BIOLOGICAL

mRNA-1283

Sterile liquid for injection

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Locations (20)

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