A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial… (NCT07117487) | Clinical Trial Compass
CompletedPhase 3
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
United States507 participantsStarted 2025-08-05
Plain-language summary
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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: Day 1 up to Day 7 (7 days post-injection)
2
Number of Participants with Unsolicited Adverse Events (AEs)
Timeframe: Day 1 up to Day 28 (28 days post-injection)
3
Number of Participants with Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation
Timeframe: Day 1 up to Day 181 (End of study)
4
Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29