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Virus Therapy

mRNA-1345 Vaccine for Respiratory Syncytial Virus (RSVictory Trial)

Phase 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up bd day 1 through day 28 (28 days post-bd day 1)
Awards & highlights

RSVictory Trial Summary

This trial is testing the safety and effectiveness of a new vaccine for RSV (respiratory syncytial virus) that is given with either a seasonal flu vaccine or a new vaccine for SARS-CoV-2 (the virus that causes COVID-19).

Who is the study for?
Adults aged 50 or older who can attend study visits, are in stable health without recent serious medical events or life-limiting diagnoses, and have completed their COVID-19 vaccination series at least 150 days prior to the trial. They should not have received any other vaccines within the last month.Check my eligibility
What is being tested?
The trial is testing mRNA-1345 vaccine's safety and immune response against Respiratory Syncytial Virus (RSV) when given alone or with a flu shot (Afluria® Quadrivalent) or an mRNA COVID-19 booster (mRNA-1273.214). It also looks at how these vaccines affect each other's immune responses.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with vaccinations such as soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea. The severity of side effects varies from person to person.

RSVictory Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~bd day 1 through day 28 (28 days post-bd day 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and bd day 1 through day 28 (28 days post-bd day 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29
Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 29
+11 more
Secondary outcome measures
Part A: GMFR of Serum Ab Level, as Measured by HAI Assay for Influenza up to Day 181
Part A: GMT of Serum Ab Level, as Measured by HAI Assay for Influenza up to Day 181
Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains From Baseline to Day 29
+22 more

RSVictory Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Part C: mRNA-1345Experimental Treatment1 Intervention
Single injection of mRNA-1345 administered IM on BD Day 1.
Group II: Part B: mRNA-1345 + mRNA-1273.214Experimental Treatment3 Interventions
Single injection of mRNA-1345 and mRNA-1273.214, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.
Group III: Part B: mRNA-1345 + PlaceboExperimental Treatment3 Interventions
Single injection of mRNA-1345 and placebo, administered IM, one in each arm on Day 1. An additional injection of mRNA-1273.214, administered on Day 29.
Group IV: Part A: mRNA-1345 + PlaceboExperimental Treatment2 Interventions
Single injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1.
Group V: Part A: mRNA-1345 + Afluria® QuadrivalentExperimental Treatment2 Interventions
Single injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1.
Group VI: Part A: Afluria® Quadrivalent + PlaceboActive Control2 Interventions
Single injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1.
Group VII: Part B: mRNA-1273.214 + PlaceboActive Control2 Interventions
Single injection of mRNA-1273.214 and placebo, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273.214
2021
Completed Phase 3
~8970
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
105 Previous Clinical Trials
61,363,764 Total Patients Enrolled

Media Library

mRNA-1345 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05330975 — Phase 3
Respiratory Syncytial Virus Research Study Groups: Part C: mRNA-1345, Part B: mRNA-1345 + Placebo, Part A: mRNA-1345 + Placebo, Part A: mRNA-1345 + Afluria® Quadrivalent, Part A: Afluria® Quadrivalent + Placebo, Part B: mRNA-1345 + mRNA-1273.214, Part B: mRNA-1273.214 + Placebo
Respiratory Syncytial Virus Clinical Trial 2023: mRNA-1345 Highlights & Side Effects. Trial Name: NCT05330975 — Phase 3
mRNA-1345 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05330975 — Phase 3

Frequently Asked Questions

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

Can people with the required qualifications enroll in this trial today?

"The clinical trial is recruiting at 34 sites across the nation and is looking for 3300 total participants. The study was first posted on 4/1/2022 and was last edited on 8/7/2022 according to information found on clinicaltrials.gov"

Answered by AI

To what degree does Afluria® Quadrivalent protect individuals?

"Afluria® Quadrivalent, which is currently in Phase 3 clinical trials, has received a safety score of 3 from our analysts. This signifies that while there is still some testing required to confirm efficacy, the medication has shown to be safe in multiple rounds of clinical trials."

Answered by AI

Is this trial widely available in many places throughout the city?

"Patients are currently being recruited at Central Research Associates Inc in Birmingham, Alabama; Revival Research Corporation - Clinedge - PPDS in Doral, Florida; Benchmark Research - Austin - HyperCore - PPDS in Austin, Texas; and 34 other sites."

Answered by AI

How many volunteers are needed for this clinical trial?

"In order to move forward, this clinical trial needs 3300 willing and eligible participants. If you meet the requirements and are interested in participating, know that you can do so at Central Research Associates Inc in Birmingham, Alabama or Revival Research Corporation - Clinedge - PPDS in Doral, Florida."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Indago Research and Health Center
Benchmark Research - Austin - HyperCore - PPDS
Sun Research Institute
Other

Why did patients apply to this trial?

Research is something that will help others. To advance medicine and new treatment options.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Sun Research Institute: < 24 hours
Average response time
  • < 1 Day
~0 spots leftby Mar 2024