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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 from 14 days postinjection up to 12 months postinjection
Summary
This trial is testing a new vaccine called mRNA-1345 to see if it can prevent lung infections caused by the RSV virus. The vaccine works by teaching the body to recognize and fight the virus. The study will include people who are at risk of these infections and will compare the effects of the vaccine to a non-treatment group.
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.
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.
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 14 days postinjection up to 12 months postinjection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 14 days postinjection up to 12 months postinjection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms
Secondary study objectives
VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD
VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD)
Trial Design
3Treatment groups
Experimental Treatment
Group I: mRNA-1345 BDExperimental Treatment1 Intervention
Single injection of mRNA-1345 on BD Day 1.
Group II: mRNA-1345Experimental Treatment1 Intervention
Single injection of mRNA-1345 on Day 1.
Group III: 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
mRNA-1345
2022
Completed Phase 3
~6360
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
121 Previous Clinical Trials
66,748,260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of chronic heart failure or COPD.I am 80 or older, can care for myself, and my chronic conditions are stable.You do not have any immune system disorders or defects from birth.Have you ever had a bad reaction to a vaccine?Your body weight is within a healthy range, neither too low nor too high.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1345 BD
- Group 2: mRNA-1345
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Respiratory Syncytial Virus Patient Testimony for trial: Trial Name: NCT05127434 — Phase 2 & 3