Phase IV open-label clinical trial of the immunogenicity and safety of standard dose trivalent inactivated influenza vaccine (Vaxigrip) in a population of people with obesity
This research study is looking closely at the standard flu jab called Vaxigrip. We want to understand how well it helps protect people who are obese from the flu. This includes understanding if people with type 2 diabetes, who are often also obese, get enough protection from the vaccine. Specifically, the study will check if their immune system, which is their body's way of fighting off infections, responds well to the vaccine. We'll also be carefully checking for any side effects to make sure the vaccine is safe for this group of people. This is an important step to ensure everyone, including those who are obese, gets the best possible protection from the flu.
At a glance
What is this study about?
This study is a bit like a check-up on the standard flu vaccine that many people already get, called Vaxigrip. We want to see how effective and safe it is, especially for people who are obese. Obesity can sometimes affect how well a person's body responds to vaccines, so it's important to make sure the flu jab works as expected for them. This study will also involve people who have type 2 diabetes, as this condition often goes hand-in-hand with obesity.
Researchers will be looking at how well the vaccine helps the body create 'antibodies'. Antibodies are like little soldiers in your immune system that fight off viruses, including the flu. We'll be checking how many of these antibodies are present before the vaccine and then again a couple of weeks after the vaccine. This helps us understand if the vaccine is doing its job and giving people good protection against the flu.
We'll also be keeping a very close eye on any side effects people might experience after getting the vaccine, both at the injection site and elsewhere in the body. The goal is to gather important information to ensure that the flu vaccine is both safe and effective for people who are obese, helping them stay healthy during flu season.
Key takeaways
- This study evaluates the standard flu vaccine (Vaxigrip) in obese individuals.
- It aims to understand vaccine effectiveness and safety for this group, including those with type 2 diabetes.
- Researchers will check how well your body creates protection (antibodies) after the vaccine.
- Any side effects will be carefully monitored.
- Participation involves receiving the vaccine, blood tests, and reporting any reactions.
- The study helps ensure flu vaccines work well for everyone.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 or over. This study is open to both men and women.
The main focus is on people who are obese. If you also have type 2 diabetes, you could still be eligible to take part. The research team will review your medical history to make sure the study is a safe and good fit for you.
It's important that you understand what's involved and are willing to take part in all visits and assessments. The study staff will explain everything to you in detail and answer any questions you have.
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 considered obese?
- Are you generally healthy enough to receive a flu vaccine?
- Are you willing to have blood samples taken?
- Can you attend study visits as required?
What does participation involve?
If you join this study, you will receive the standard 'Vaxigrip' flu vaccine as an injection. Before getting the vaccine, the study team will take a blood sample to measure your body's existing protection against the flu. This is called a 'pre-vaccination' sample. About two weeks after you receive the vaccine, you will have another visit where another blood sample will be taken. This second sample will help the researchers see how well your body has responded to the vaccine and made protective antibodies.
During the study, especially in the week after your vaccination, you will be asked to keep track of any side effects you might experience, both at the injection site (like soreness or redness) and anywhere else in your body. The study team will provide you with clear instructions on how to do this. There will also be ongoing checks for any serious or unexpected side effects over the course of the study. The total duration of your participation in the study will involve these few visits and monitoring periods.
Potential risks and benefits
Locations (1)
- —UnverifiedSweden
Common questions
What is the main goal of this study?
The main goal is to see how well the standard flu vaccine (Vaxigrip) protects obese people, including those with type 2 diabetes, and to check for any side effects.
What is Vaxigrip?
Vaxigrip is the name of a common, standard flu vaccine that helps protect against the flu virus.
What does 'immunogenicity' mean?
It means how well your body's defence system (immune system) reacts to the vaccine and creates protection against the flu.
Will I have to pay to be part of this study?
No, you should not have to pay to participate in a clinical trial. All study-related treatments and assessments are usually covered by the study.
What if I get sick during the study?
You should always tell the study team about any health issues you experience while taking part. They are there to monitor your health and safety.
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.