Clinical Trial

A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated August 8, 2025 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to \<60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2023-09-27; most recent amendment 2025-08-05.
Status change: Recruiting → Active, Not Recruiting 2024-08-13
Status change: Not Yet Recruiting → Recruiting 2023-11-16
Trial Details
NCT Number NCT06067230
Lead Sponsor ModernaTX, Inc.
Conditions Respiratory Syncytial Virus
Enrollment 1,153 participants
Start Date 2023-10-06
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-08