Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

Investigating Safety and Immune Response of an Investigational Vaccine for RSV and hMPV in Older Adults

Not Recruiting
60 years - 75 years
All
Phase 1
385 participants needed

Study Overview

VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.

Study Details

The duration of participation will be approximately 6 months for each participant.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: RSV Infection, hMPV
  • Age: 60 years - 75 years
  • Gender: All

Inclusion Criteria:

  • Aged 60 to 75 years on the day of inclusion
  • A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile

Exclusion Criteria:

  • 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.

Updated on 24 Apr 2025. Study ID: NCT06583031

This study investigates the safety and immune response of an investigational vaccine for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in older adults. RSV and hMPV are viruses that can cause respiratory infections, especially in older people. The purpose of this study is to understand how the body reacts to different doses of the vaccine in adults aged 60 to 75 years.

Participants will receive a single injection of the investigational vaccine. The study will monitor the participants to see how their immune system responds and to check for any side effects. The study includes various procedures such as health assessments and blood tests to gather this information.

  • Who can participate: Adults aged 60 to 75 years can participate. Female participants must be post-menopausal for at least one year or surgically sterile. Participants should not have any condition that might interfere with the study.
  • Study details: Participants will receive a single injection of the investigational vaccine. Health assessments and blood tests will monitor safety and immune response.
  • Study timelines: The study will last approximately 6 months.