A study to evaluate the safety and efficacy of mRNA-1345 vaccine targeting respiratory syncytial virus (RSV) in adults ≥60 years of age
A study to evaluate the safety and efficacy of mRNA-1345 vaccine targeting respiratory syncytial virus (RSV) in adults ≥60 years of age
| Trial Fact Box | |
|---|---|
| NCT Code | NCT05127434 |
| Sponsor | ModernaTX, Inc. |
| Study type(s) | Interventional |
| Phase | Phase 2 / Phase 3 |
| Estimated enrolment | 36814 |
| Study Start (Actual) | 17 November 2021 |
| Primary Completion (Estimated) | 28 July 2025 |
| Study Completion (Actual) | 28 July 2025 |
Official Title:
A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age
Brief Summary:
The main purpose of Part A 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.
The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
Detailed Description:
The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Part A Phase 2 segment, up to 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 Part A Phase 3 segment, approximately 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.
In the Part B substudy, 1500 participants who received a dose of mRNA-1345 in Part A Phase 3 will be randomly assigned in a 2:1 randomization ratio to receive a single BD injection of either mRNA-1345 at the selected dose or placebo.