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

NCT05127434 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36814

Last updated 2025-08-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Placebo

0.9% sodium chloride (normal saline) injection

DRUG

mRNA-1345

Sterile liquid for injection

Sponsors & Collaborators

  • ModernaTX, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2025-07-28
Completion
2025-07-28
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05127434 on ClinicalTrials.gov