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

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 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months postinjection

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

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

Primary study objectives

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

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Secondary study objectives

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)

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