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

Completed · Phase 1

Conditions studied: Respiratory Syncytial Virus Infection, Healthy Volunteers, Metapneumovirus Infection

In brief

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

Key facts

Study ID

NCT06237296

Run by

Sanofi Pasteur, a Sanofi Company

People needed

558

Starts

2024-01-23

Expected to finish

2025-02-11

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Velocity Gardena Site Number : 8400011 — Gardena, California, United States
• Velocity Clinical Research-Hallandale Beach- Site Number : 8400013 — Hallandale, Florida, United States
• Advanced Clinical Research- Site Number : 8400005 — Meridian, Idaho, United States
• Velocity Clinical Research, Sioux City Site Number : 8400017 — Sioux City, Iowa, United States
• Velocity Clinical Research- New Orleans Site Number : 8400016 — New Orleans, Louisiana, United States
• Meridian Clinical Research- Site Number : 8400007 — Binghamton, New York, United States
• Velocity Clinical Research- Site Number : 8400012 — Cleveland, Ohio, United States
• Coastal Carolina Research Center- Site Number : 8400001 — North Charleston, South Carolina, United States
• Charlottesville Medical Research Center Winding River - Site Number : 8400002 — Charlottesville, Virginia, United States
• Investigational Site Number : 0360006 — Blacktown, New South Wales, Australia
• Investigational Site Number : 0360002 — Botany, New South Wales, Australia
• Investigational Site Number : 0360003 — Kanwal, New South Wales, Australia
• Investigational Site Number : 0360004 — Sydney, New South Wales, Australia
• Investigational Site Number : 0360008 — Herston, Queensland, Australia
• Investigational Site Number : 0360005 — Morayfield, Queensland, Australia
• Investigational Site Number : 0360001 — Camberwell, Victoria, Australia
• Investigational Site Number : 0360007 — Canberra, Australia

Full record on ClinicalTrials.gov

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