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RSV booster shot shows promise for seniors

NCT ID NCT07117487

Disease control Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new mRNA booster shot (mRNA-1345) in 507 adults aged 60 and older who had already received a licensed RSV vaccine at least a year earlier. The goal was to see if the booster is safe and boosts the immune system's ability to fight RSV. Researchers measured side effects and antibody levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-1345 (an mRNA-based RSV vaccine booster)
What this could lead to
If successful, this could show that an mRNA booster safely strengthens protection against RSV in older adults who already received a different RSV vaccine.
What could go wrong
This is a completed phase 3 study, but results are not yet published. The booster may not provide significantly better immunity than the original vaccine, and side effects like injection site pain or fever are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

507 people

The number who actually took part.

Started

Aug 2025

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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. Key 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. Other protocol-specified inclusion and/or exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease viral infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus

Contacts and locations

Locations

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012, United States

  • Velocity Clinical Research, Austin

    Austin, Texas, 78759, United States

  • Velocity Clinical Research, Covington

    Covington, Louisiana, 70433, United States

  • Velocity Clinical Research, Denver

    Denver, Colorado, 80110, United States

  • Velocity Clinical Research, Hampton

    Hampton, Virginia, 23666, United States

  • Velocity Clinical Research, Lincoln

    Lincoln, Nebraska, 68510, United States

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research, Rockville

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research, Savannah

    Savannah, Georgia, 31406, United States

  • Velocity Clinical Research, Spokane

    Spokane, Washington, 99218, United States

  • Velocity Clinical Research, Valparaiso

    Valparaiso, Indiana, 46383, United States

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