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Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older

Not Recruiting
18 years of age
Both
Phase 1

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Overview

The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older.

Treatment
  • RSV/hMPV mRNA / LNP 1 at 3-4 different doses or,
  • RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or,
  • RSV mRNA / LNP 1 at 1 dose or,
  • hMPV mRNA / LNP 1 at 1 dose

Description

Study duration per participant is approximately 6 months.

Eligibility

Inclusion Criteria:

-Informed consent form (ICF) has been signed and dated

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

        -Any condition which, in the opinion of the Investigator, might interfere with the
        evaluation of the study objectives.
        --The above information is not intended to contain all considerations relevant to a
        patient's potential participation in a clinical trial.

Study details

Respiratory Syncytial Virus Infection, Healthy Volunteers, Metapneumovirus Infection

NCT06237296

Sanofi Pasteur, a Sanofi Company

7 March 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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