← Back to Search

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 baseline to bd day 361

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to bd day 361

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to bd day 361

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to bd day 361 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 29

Parts A and B: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 29

Secondary study objectives

Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains From Baseline to Day 29

Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains From Baseline up to Day 181

Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 181

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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