A Phase 3, Global, Randomized, Modified Double-Blind, Placebo‑Controlled, Study to Evaluate the Efficacy, Immunogenicity, and Safety of IVX-A12, a Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV) Virus-Like Particle (VLP) Vaccine in Adults 60 Years of Age and Older.
This research is a large study (Phase 3) looking at a new vaccine called IVX-A12. It's designed for people aged 60 and over to protect them from two chest infections: Respiratory Syncytial Virus (RSV) and human Metapneumovirus (hMPV). These viruses can cause cold-like symptoms, but they can be more serious for older adults, sometimes leading to breathing difficulties. Participants will either receive the new vaccine or a dummy injection (placebo) to fairly compare how well the vaccine works and if it's safe. Researchers will closely watch to see if people who get the vaccine are less likely to catch RSV or hMPV-related chest infections over one or two winter seasons.
At a glance
What is this study about?
This clinical trial is investigating a new vaccine called IVX-A12 designed to protect older adults from two common viruses: Respiratory Syncytial Virus (RSV) and human Metapneumovirus (hMPV). These viruses are responsible for cold-like symptoms but can sometimes lead to more serious breathing problems, especially in people over 60. The aim of this study is to thoroughly test if this new vaccine is both effective at preventing these infections and safe to use.
To ensure fair testing, some participants will receive the new IVX-A12 vaccine, while others will be given a 'placebo'. A placebo is a dummy injection that contains no active medicine, like a tiny amount of salt water. This is done so researchers can accurately compare the health outcomes between the two groups without knowing who received which treatment. This helps us understand what effects are truly due to the vaccine.
The main things researchers will be looking for are how many people get an RSV or hMPV-related chest infection after getting the vaccine, compared to those who received the placebo. They will track this over one and then two winter seasons to get a full picture of the vaccine's protection. They will also pay close attention to any side effects to make sure the vaccine is safe.
Key takeaways
- Tests a new vaccine (IVX-A12) for RSV and hMPV.
- Aims to protect adults aged 60 and over.
- Compares the vaccine to a dummy injection (placebo).
- Looks for protection against chest infections over two seasons.
- Investigates both effectiveness and safety of the vaccine.
- Participation could last up to two years.
Who may be eligible?
This study is looking for adults who are 18 years old or older. There is no upper age limit for taking part in this specific trial.
Both men and women are welcome to participate. The study aims to include a diverse group of people to understand how the vaccine works across different individuals.
To find out if you are suitable for this study, the research team will ask you some questions about your health and medical history. This is to make sure the study is right for you and to keep you safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you able to attend regular appointments for the study?
- Are you willing to potentially receive either the study vaccine or a placebo?
- Are you interested in helping research against RSV and hMPV?
What does participation involve?
If you decide to take part, you would receive either the new vaccine or a placebo injection at the start of the study. You wouldn't know which one you received, nor would the doctors caring for you in the study. Throughout the study, you would have regular appointments, either in person or by phone, where the research team would check your health, ask about any symptoms you're experiencing, and monitor for any side effects. You might also be asked to provide blood samples at certain times. The study will follow you over one to two winter seasons to see how well the vaccine works, and what your body's immune system reaction is. The total duration of your participation could be up to two years.
Potential risks and benefits
Locations (8)
- —UnverifiedSpain
- —UnverifiedEstonia
- —UnverifiedBulgaria
- —UnverifiedGermany
- —UnverifiedFinland
- —UnverifiedPoland
- —UnverifiedSweden
- —UnverifiedBelgium
Common questions
What are RSV and hMPV?
RSV and hMPV are common viruses that can cause symptoms like a cold, but they can be more serious for older people, sometimes leading to chest infections.
What is a placebo?
A placebo is a 'dummy' injection, often just salt water, given to some participants so researchers can fairly compare the vaccine's effects against no treatment.
How long will the study last?
The study will follow participants for up to two winter seasons, so your involvement could last for up to two years.
What does a 'Phase 3' study mean?
Phase 3 means this is a large study testing the vaccine on many people to confirm if it works and is safe before it might be made available to everyone.
Will I know if I got the real vaccine or the placebo?
No, neither you nor the study team will know which you received during the study. This helps keep the results unbiased and accurate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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