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
Study of an Investigational Vaccine for Respiratory Viruses in Adults
Study 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
Study Details
Study duration per participant is approximately 6 months.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Respiratory Syncytial Virus Infection, Healthy Volunteers, Metapneumovirus Infection
-
Age: 18 years or above
-
Gender: All
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.
This study investigates an investigational vaccine designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in older adults. Lower respiratory tract disease affects the lungs and airways, causing symptoms like coughing and difficulty breathing. The vaccine uses messenger ribonucleic acid (mRNA) technology to help the body recognize and fight these viruses.
Participants in the study will receive a single injection of the investigational vaccine. The vaccine will be given at different doses and is formulated with lipid nanoparticles, which help deliver the mRNA into cells. The study includes different arms where participants may receive various combinations of the vaccine targeting RSV and/or hMPV.
- Who can participate: Healthy adults aged 18 to 49 years and 60 years and older can participate. Participants must sign an informed consent form. Individuals with conditions that might interfere with study objectives are excluded.
- Study details: Participants will receive a single injection of the investigational vaccine. The vaccine is given in different doses and formulations. The study involves different arms to test various combinations of the vaccine. No placebo is used in this study.
- Study timelines: The study will last 6 months.
