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Clinical Trials in the USA / NCT07266558
Active, not recruiting Phase 4

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)

NCT07266558 · tracked via the Priya Life Science USA tracker
Sponsor
ModernaTX, Inc.
Phase
Phase 4
Started
2025-11-26
Last updated
2026-04-28

Condition(s) studied

SARS-CoV-2

Investigational drug(s) / intervention(s)

mRNA-1273mRNA-1283Placebo

mRNA-1273: Sterile liquid for injection

mRNA-1283: Sterile liquid for injection

Placebo: 0.9% sodium chloride (normal saline) injection

Study summary

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)

Trial sites (150)

FacilityCityRegionStatus
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.

More ModernaTX, Inc. trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT07266558 on ClinicalTrials.gov ↗ ← All trials in the USA