NCT05127434

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 36,814 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
DRUG	Placebo	0.9% sodium chloride (normal saline) injection
DRUG	mRNA-1345	Sterile liquid for injection

Timeline

• Start date: 2021-11-17
• Primary completion: 2025-07-28
• Completion: 2025-07-28
• First posted: 2021-11-19
• Last updated: 2025-08-19

Locations

269 sites across 23 countries: United States, Argentina, Australia, Bangladesh, Belgium, Canada, Chile, Colombia, Costa Rica, Finland, Germany, Japan, Mexico, New Zealand, Panama, Poland, Puerto Rico, Singapore, South Africa, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study