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
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
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.
Key Inclusion Criteria:
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:
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.
La Mesa, California 91942, United States
DeLand, Florida 32720, United States
Lakeland, Florida 33803, United States
Largo, Florida 33777, United States