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Virus Therapy

mRNA-1345 Vaccine for Respiratory Syncytial Virus

Phase 2 & 3
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults ≥ 80 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (specifically chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable as assessed by the following criteria: absence of changes in medical therapy within 1 month due to treatment failure or toxicity; absence of medical events qualifying as SAEs within 1 month of the planned study injection on Day 1; and absence of known, current, and life-limiting diagnoses, which could continue for the duration of the primary efficacy period (12 months from study injection on Day 1) and which, in the opinion of the investigator, would make completion of the protocol unlikely.
Body mass index from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months postinjection
Awards & highlights

Study Summary

This trial is testing a new RSV vaccine to see if it is safe and effective.

Who is the study for?
This trial is for adults aged 60 and older who are generally healthy, can care for themselves, and may have stable chronic conditions like heart failure or lung disease. They must not have had severe vaccine reactions before, should not be undergoing changes in medical therapy, nor have life-limiting diagnoses that could prevent them from completing the study.Check my eligibility
What is being tested?
The trial is testing mRNA-1345 vaccine's safety and its ability to prevent serious lung infections caused by RSV compared to a placebo. Participants will receive one dose of either the vaccine or placebo and will be monitored for up to 12 months post-injection.See study design
What are the potential side effects?
While specific side effects aren't listed here, common side effects of vaccines include soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea. Serious side effects are rare but can include allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 80 or older, can care for myself, and my chronic conditions are stable.
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Your body weight is within a healthy range, neither too low nor too high.
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Have you ever had a bad reaction to a vaccine?
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You do not have any immune system disorders or defects from birth.
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I have a history of chronic heart failure or COPD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months postinjection
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months postinjection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal up to 24 Months Postinjection
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) up to 7 Days Postinjection
Number of Participants with Unsolicited Adverse Events (AEs) up to 28 Days Postinjection
+2 more
Secondary outcome measures
Geometric Mean Concentration (GMC) of Serum RSV Binding Abs
Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers
Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibodies (Abs)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: mRNA-1345Experimental Treatment1 Intervention
Single injection of mRNA-1345 on Day 1.
Group II: PlaceboExperimental Treatment1 Intervention
Single injection of mRNA-1345 matching-placebo on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,341,568 Total Patients Enrolled

Media Library

mRNA-1345 Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05127434 — Phase 2 & 3
Respiratory Syncytial Virus Research Study Groups: mRNA-1345, Placebo
Respiratory Syncytial Virus Clinical Trial 2023: mRNA-1345 Vaccine Highlights & Side Effects. Trial Name: NCT05127434 — Phase 2 & 3
mRNA-1345 Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05127434 — Phase 2 & 3
Respiratory Syncytial Virus Patient Testimony for trial: Trial Name: NCT05127434 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a significant number of hospitals participating in this trial within the state?

"74 patients are enrolled in this study with locations at the Washington Health Institute, Velocity Clinical Research, Valparaiso, Meridian Clinical Research, as well as 74 other sites."

Answered by AI

Are we able to include new patients in this research project?

"This trial, which was first advertised on November 17th 2021, is still looking for participants. The December 23rd 2021 edit to the listing on clinicaltrials.gov was likely a typos."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Virginia
Other
Maryland
How old are they?
65+
18 - 65
What site did they apply to?
Benchmark Research - Metairie - HyperCore - PPDS
Desert Clinical Research, LLC - CCT
Washington Health Institute
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I don't have. Am new to the program. I wish to advance medical science. I would like to help with new drug developments.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
2021. "A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05127434.
All > Rsv
~12186 spots leftby Aug 2025
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