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Clinical Trial Summary

The main purpose of this study is to evaluate the safety and tolerability of 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.


Clinical Trial Description

The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Phase 2 segment, between 400 and 2,000 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. In the Phase 3 segment, between 32,000 and 33,600 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05127434
Study type Interventional
Source ModernaTX, Inc.
Contact Moderna Clinical Trials
Phone 877-913-3286
Email [email protected]
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date November 12, 2021
Completion date November 30, 2024

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