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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
30,000
VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection
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).
Time frame: Day 1 through Day 181
Vaccine Efficacy (VE) of mRNA-1283 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection
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).
Time frame: Day 1 through Day 181
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: 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
Time frame: Day 1 through Day 181
Number of Participants with a First Event of Severe COVID-19 after Study Injection
Time frame: Day 1 through Day 181
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