Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
Investigating the Safety and Body's Defense Response of a Vaccine in Older Adults
Study Overview
The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
Study Details
The study duration will be up to approximately 12 months minus the screening period.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Respiratory Syncytial Virus Infection, Metapneumovirus Infection, Parainfluenzae Virus Infection
-
Age: 60 years or above
-
Gender: All
Inclusion Criteria:
- Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).
- Informed consent form (ICF) has been signed and dated
- A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
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.
Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
This study investigates the safety and immune response of a vaccine in older adults. The vaccine aims to protect against three viruses: respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The purpose of this study is to see if the vaccine can help the body make antibodies, which are germ-fighting agents. Antibodies are important because they help the body fight off infections.
Participants in the study will receive different doses of the vaccine. Some will get a vaccine with only PIV3, others will get a combination of RSV, hMPV, and PIV3, or RSV and hMPV, or only RSV. The study will test these different combinations to see which is most effective.
- Who can participate: Adults aged 60 years and older can participate. Female participants must be of non-childbearing potential.
- Study details: Participants will receive different doses of the investigational vaccine. The study will test combinations of the vaccine to determine the most effective against the viruses.
- Study timelines: The study will last up to approximately 12 months.
