A Phase III, open-label, randomized, controlled, multi-country study to evaluate the immune response, safety and reactogenicity of RSVPreF3 OA investigational vaccine when co-administered with 20-valent pneumococcal conjugate vaccine (PCV20) in adults aged 60 years and older.
This research is testing a new vaccine for Respiratory Syncytial Virus (RSV) in people aged 60 and over. RSV can cause serious lung infections, especially in older adults. The study aims to see how well the new RSV vaccine works and if it's safe when given together with an existing vaccine for pneumonia. Researchers will check the body's immune response to both vaccines after one month. They will also keep an eye on any side effects and how participants feel after getting the vaccines. This important study will help us understand if giving both vaccines at once is a good and safe way to protect older people from these common and potentially serious illnesses.
At a glance
What is this study about?
This clinical study is designed to learn more about a new vaccine that aims to protect older adults from Respiratory Syncytial Virus (RSV). RSV is a common virus that can cause mild cold-like symptoms, but it can also lead to more serious lung infections like bronchitis and pneumonia, especially in people aged 60 and over. These infections can sometimes be severe and require hospitalisation.
The main goal of this study is to see how well this new RSV vaccine works in older adults and whether it's safe to give it at the same time as the pneumonia vaccine (called Apexxnar). Giving both vaccines together could make it more convenient for people to get protected from these two important diseases. Researchers will check participants' blood to see how their immune system responds to both vaccines and will also carefully record any side effects that might occur.
This kind of study, called a Phase III trial, is a crucial step in vaccine development. It helps confirm if a new vaccine is effective and safe for widespread use. By taking part, volunteers are helping scientists understand more about how best to protect older adults from RSV and pneumonia, potentially leading to new ways to keep people healthy.
Key takeaways
- This study is testing a new RSV vaccine for adults aged 60 and over.
- It checks if the RSV vaccine is safe and effective when given with a pneumonia vaccine.
- Researchers will measure the body's immune response to both vaccines.
- Safety and side effects will be carefully monitored throughout the study.
- Participation helps advance understanding of how to protect older adults from serious infections.
Who may be eligible?
This study is looking for adults who are 18 years old or older. Both men and women can take part.
However, it's important to remember that this is a simplified overview. There will be specific health checks and criteria that determine if someone is a good fit for the study. For instance, people with certain medical conditions or who are taking specific medications might not be able to participate. The study is specifically focused on those aged 60 and older, even though the general eligibility starts at 18.
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 (the study is particularly interested in those 60+)?
- Are you generally healthy, or do you manage your health conditions well?
- Are you willing to attend study visits and have blood samples taken?
- Are you comfortable with receiving an investigational (new) vaccine?
What does participation involve?
If you decide to take part in this study, you would receive the new RSV vaccine and the pneumonia vaccine. Researchers would then monitor your health and take blood samples at specific times to check your body's response to the vaccines. They would also ask you about any side effects you might experience. The total duration of your participation would involve follow-up over several months to ensure your safety and to see how long the vaccines continue to protect you.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedPoland
Common questions
What is RSV?
RSV stands for Respiratory Syncytial Virus. It's a common virus that can cause cold-like symptoms, but it can be serious for babies and older adults, sometimes leading to severe lung infections.
What is Apexxnar?
Apexxnar is a vaccine that helps protect against pneumonia, which is a serious lung infection. In this study, it's being given alongside the new RSV vaccine.
Why are they giving two vaccines at once?
Doctors want to see if giving both the new RSV vaccine and the pneumonia vaccine at the same time is safe and still works well. This could make it easier for people to get protected from both illnesses.
What does 'immune response' mean?
Immune response means how your body reacts to a vaccine. When you get a vaccine, your body learns to fight off the virus, and the study will check how strongly your body's defences respond.
What does 'Phase III' mean?
Phase III is a stage in testing new medicines or vaccines. It means the vaccine has already been tested in smaller groups, and now it's being tested in a larger group of people to confirm it's safe and works well.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.