Table of contents
- Trial overview
- Who can participate
- What is being tested
- Trial phase and design
- What the study measures
- Key patient terms
Trial overview
The available study is an interventional trial, which means researchers give a treatment or a comparison product and then watch what happens.[1]
This trial is authorised and is studying an RSV and hMPV vaccine in adults aged 60 years and older.[1]
The study focuses on respiratory syncytial virus and human metapneumovirus, both of which can cause breathing illness.[1]
Who can participate
The target population is adults aged 60 years and older.[1]
This age group is important because the trial is looking at illness prevention in older people, who may have a higher risk of serious lung disease.[1]
What is being tested
The study compares a single intramuscular injection of HUMAN METAPNEUMOVIRUS, VIRUS-LIKE PROTEIN as part of IVX-A12 with placebo.[1]
The placebo is 0.9% salt water for injection, which does not contain the active study vaccine.[1]
The brief summary says the purpose is to test whether this vaccination can help prevent confirmed RSV lower respiratory tract disease and hMPV lower respiratory tract disease during the first season after vaccination.[1]
Trial phase and design
This is a Phase 3 study.[1]
Phase 3 studies are usually large studies that compare a treatment with a control group to better understand whether it works and whether it is safe enough for broader use.[1]
The planned enrollment is 29,450 participants, which shows that this is a very large study.[1]
What the study measures
The main outcomes are the occurrence of the first RSV-confirmed lower respiratory tract disease and the first hMPV-confirmed lower respiratory tract disease starting on Day 15 during the first season.[1]
Primary outcome means the main result the researchers want to measure to decide whether the study treatment works.[1]
The study also looks at efficacy, which means how well the vaccine helps prevent disease, and immunogenicity, which means how strongly the immune system responds.[1]
Safety is also part of the study, so researchers are watching how the vaccine performs in the trial population.[1]
Key patient terms
Lower respiratory tract disease means illness in the airways and lungs below the throat, such as the bronchi and lungs.[1]
Confirmed means the illness was shown by testing to be caused by RSV or hMPV.[1]
Day 15 is the time point after vaccination when the study starts counting the main outcome events.[1]
First season means the first virus season after vaccination, when the study checks for disease events.[1]
