NCT05815498

A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19

A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283 Compared With mRNA-1273 in Participants Aged ≥12 Years for the Prevention of COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14,246 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1283.222	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.222	Sterile liquid for injection
BIOLOGICAL	mRNA-1283.815	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.815	Sterile liquid for injection

Timeline

• Start date: 2023-03-28
• Primary completion: 2025-04-12
• Completion: 2025-04-12
• First posted: 2023-04-18
• Last updated: 2025-05-07

Locations

230 sites across 4 countries: United States, Canada, Japan, United Kingdom

Regulatory

• FDA-regulated drug study