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Cancer Vaccine

mRNA-1345 Vaccine for RSV

Verified Trial
Phase 3
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You are 18 years of age or older.
You are 18 years of age or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 28 (28 days post injection) for part a and day 1 through day 84 (28 days post second injection) for part b
Awards & highlights

Study Summary

This trial will test a new vaccine in adults at high risk or who have had a solid organ transplant.

Who is the study for?
This trial is for adults aged 18-59 with heart disease, chronic lung conditions, or stable diabetes on medication. It's also for those over 18 who've had an organ transplant and are on anti-rejection drugs. People can't join if they're in another study, have unstable health issues that could affect safety or results, severe allergies to the vaccine ingredients, recent use of immune-modifying drugs, a history of certain heart inflammations, or recent organ rejection.Check my eligibility
What is being tested?
The trial tests mRNA-1345 vaccine's safety and immune response in two groups: high-risk adults (Part A) and adult solid organ transplant recipients (Part B). The goal is to see how well the vaccine works in these different populations who are at higher risk from respiratory syncytial virus.See study design
What are the potential side effects?
While not specified here, typical side effects of vaccines may include pain at injection site, fatigue, headache, muscle pain, chills fever and nausea. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 28 (28 days post injection) for part a and day 1 through day 84 (28 days post second injection) for part b
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 28 (28 days post injection) for part a and day 1 through day 84 (28 days post second injection) for part b 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)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
+3 more
Secondary outcome measures
Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Part A: Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part B: mRNA-1345 Dose 2Experimental Treatment1 Intervention
Two injections of mRNA-1345 administered IM on Day 1 and Day 57.
Group II: Part A: mRNA-1345 Dose 2Experimental Treatment1 Intervention
Single injection of mRNA-1345 administered IM on Day 1.
Group III: Part A: mRNA-1345 Dose 1Experimental Treatment1 Intervention
Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1.

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,378,167 Total Patients Enrolled

Frequently Asked Questions

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

Are there numerous locations conducting this investigation in the US?

"The trial encompasses 48 distinct medical centres, such as Foothills Research Center - CCT - PPDS in Phoenix, Fiel Family & Sports Medicine - PC - CCT - PPDS in Tempe, and the David Geffen School of Medicine at UCLA."

Answered by AI

Is there a risk associated with administering the first dose of mRNA-1345 Part A?

"Assessing the safety of Part A: mRNA-1345 Dose 1, our team has assigned a score of 3 since this is an advanced phase study that has proven efficacy and multiple studies confirming its security."

Answered by AI

Is enrollment for this research study still available?

"From what is posted on clinicaltrials.gov, this research project has ceased its recruitment of participants as the most recent editing was done on September 27th 2023 and it first appeared online on October 4th 2023. Despite that, there are 104 other trials with open positions available currently."

Answered by AI

Who else is applying?

What site did they apply to?
David Geffen School of Medicine at UCLA
Excel Medical Clinical Trials DBA Flourish
Clinical Research Atlanta - Headlands - PPDS
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults
2023. "A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067230.
All > New Orleans
~767 spots leftby Dec 2025
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