Clinical Trial Info

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

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The main purpose of the ConquerRSV Phase 2/3 study is to evaluate the safety and tolerability of the mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months.

Phase 2 of the study will include 2,000 participants who will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

In the Phase 3 portion of the study, 35,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

Results

On January 17, 2023, Moderna announced mRNA-1345 met the primary efficacy endpoints in the Phase 3 portion of the study.

These endpoints include vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms.

Based on these results, Moderna intends to submit for regulatory approval in the first half of 2023.