A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of Age

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2026-04-15

Brief Summary

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The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.

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Detailed Description

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Conditions

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Respiratory Syncytial Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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mRNA-1345

Participants will receive a single dose of mRNA-1345 injection administered intramuscularly on Day 1.

Group Type EXPERIMENTAL

mRNA-1345

Intervention Type BIOLOGICAL

Suspension for injection

Interventions

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mRNA-1345

Suspension for injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:

* Absence of changes in medical therapy within 60 days of Visit 1 due to treatment failure or toxicity.
* Absence of serious or significant medical events within 30 days of Visit 1.
* Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.
* Participant has received a single dose of Arexvy or Abrysvo at least 12 months prior to Visit 1. Participants must provide proof of RSV vaccination status (including brand and date received) prior to enrollment.

Exclusion Criteria

* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤14 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 14 days after the study injection. Nonstudy vaccination(s) should not be delayed.
* Prior participation in research involving receipt of any investigational RSV product (drug/biologic).
* Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to Visit 1 or plans to receive them during the study.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes