A clinical trial of the safety of the live, attenuated influenza vaccine nasal spray in children aged 12 - 23 months
This study is checking a nasal spray flu vaccine for babies and toddlers aged 12 to 23 months. Flu can make young children very unwell, but currently, the nasal vaccine is only for children aged two and older. Doctors need to make sure it's safe for younger children, especially concerning how it might affect their breathing. Children in the study will get either the real vaccine or a dummy (placebo) spray, and later they'll get the one they didn't have first. Researchers will carefully watch for any breathing problems. If it's safe, the vaccine might be offered to more young children in the future, helping to protect them and others from flu.
At a glance
What is this study about?
Each winter, the flu can cause people to become very ill, especially young children, older people, and those with weaker immune systems. Currently, children aged two and above in the UK are offered a nasal spray flu vaccine. This vaccine not only protects them but also helps stop the flu from spreading to others. However, children under two, who are actually at the highest risk from flu, haven't been offered this vaccine yet because we needed more information about its safety for this particular age group.
This study aims to find out if the nasal flu vaccine is safe for children aged 12 to 23 months. Specifically, we want to know if it causes any breathing problems, like wheezing. If the study shows it's safe, it could mean that the nasal flu vaccine might be offered to all children aged 12 months and older in the future, giving them important protection against the flu.
We're working with a company called uMed, which helps connect people with research studies like this. They use technology to invite patients and help make sure the study runs smoothly, just like they did for another important study about protecting babies from a different virus.
Key takeaways
- This study tests a nasal flu vaccine for children aged 12-23 months.
- It aims to check the vaccine's safety, especially for breathing problems like wheezing.
- Every child will receive both the real vaccine and a dummy (placebo) spray during the study.
- The study could lead to the vaccine being offered to younger children in the future.
- Participation involves two visits and some remote surveys.
- The study is backed by the NHS and funded by a leading UK research body.
Who may be eligible?
This study is looking for children who are between 12 months old and just shy of their second birthday. Their parent or legal guardian must be happy to give their agreement for them to take part.
Children can join if they are generally in good health, even if they have some mild conditions like eczema, or a history of chesty coughs (bronchiolitis) or wheezing caused by viruses. However, children who have already had a flu jab by injection, received any other new trial medicine in the last month, or live with someone who has a very weak immune system, will not be able to join.
Also, children who are already due to get the annual flu vaccine through the NHS (for example, if they have certain serious health conditions), or who have severe allergies to ingredients in the vaccine (like a severe egg allergy, or any history of anaphylaxis), or are currently being treated for cancer, cannot take part.
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.
- Is your child between 12 months and just under 2 years old?
- Are you happy to give written permission for your child to join?
- Is your child generally healthy, perhaps with mild eczema or a history of chesty coughs?
- Has your child NOT had a flu jab by injection before?
- Does your child NOT have a very weak immune system or a severe allergy to vaccine ingredients (like severe egg allergy or history of anaphylaxis)?
- Is your child NOT currently receiving treatment for cancer?
What does participation involve?
If your child takes part, they will have two study visits. At the first visit, they will receive a nasal spray – it will either be the flu vaccine or a dummy (placebo) spray, and neither you nor the study team will know which it is at that moment. After this, over the next four weeks, we'll be checking to see how many children need to see their doctor for wheezing. At the second visit, your child will receive whichever nasal spray they didn't get at the first visit, meaning every child will eventually receive both the real vaccine and the dummy spray.
We will carefully compare how many children experience wheezing after getting the vaccine compared to after getting the dummy spray. You will also fill out some surveys from home, which means fewer trips to the clinic. Clear instructions will be given on when to seek normal NHS care if you are worried about your child's health.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
What is 'live, attenuated' flu vaccine?
It means the vaccine uses a weakened form of the flu virus, which helps the body build protection without causing the illness.
What is a placebo nasal spray?
A placebo is a dummy spray that looks just like the real vaccine but doesn't contain any active medicine. It helps us compare the vaccine's effects.
Why don't we know if my child gets the vaccine or placebo first?
This helps make sure the results are fair and unbiased. The study is designed so every child eventually gets both the vaccine and the placebo.
When will the study results be known?
The study runs from June 2025 to January 2026, and results will be reviewed after that time.
Who is paying for this study?
The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.
How to find out more
Alasdair Munro
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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