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

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).

Timeline

Start

2023-03-28

Primary completion

2025-04-12

Completion

2025-04-12

Outcome

Met primary endpoint

paper The rVE and immunogenicity non-inferiority criteria were met, with higher antibody responses for mRNA-1283 versus mRNA-1273. PMID 40639387 ↗

registry analysis (non-inferiority test); Part 1: mRNA-1283.222 vs Part 1: mRNA-1273.222; p = 0.0005; rVE 9.31 (99.4% CI -6.58 to 22.83); Cox proportional hazard model NCT05815498 ↗

registry analysis (non-inferiority test); Part 1: mRNA-1283.222 vs Part 1: mRNA-1273.222; GMR 1.335 (95% CI 1.194 to 1.492) NCT05815498 ↗

Publications

• Chalkias S, Dennis P, Petersen D, Radhakrishnan K, Vaughan L, Handforth R, Rossi A, Wahid R, Edwards DK, Feng J, Deng W, Zhou H, De Windt E, Urdaneta V, Paila Y, Girard B, Faust SN, Walsh SR, Cosgrove CA, Miller J, Das R. Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine (NextCOVE): results from a phase 3, randomised, observer-blind, active-controlled trial. Lancet Infect Dis. 2025 Nov;25(11):1230-1242. doi: 10.1016/S1473-3099(25)00236-1. Epub 2025 Jul 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mRNA-1273.222	Vaccine	50 ug	Intramuscular
Subject	mRNA-1273.815	Messenger RNA (mRNA)	—	Intramuscular
Subject	mRNA-1283.222	Unknown	10 ug	Intramuscular
Subject	mRNA-1283.815	Unknown	—	—

Indications