Randomized, Observer-Blind, Active-Controlled, Phase III Study in Adults ≥ 60 years of Age to Assess the Safety and Immunogenicity of Abbott’s Candidate High-Dose Influenza Vaccine.
Influenza, commonly known as the flu, can cause severe illness in older adults because our immune defences naturally weaken as we get older. Standard flu jabs might not always give older adults enough protection, which is why scientists develop 'high-dose' vaccines. This Phase 3 trial compares a new high-dose flu jab made by Abbott with existing flu vaccines. The aim is to see how well the body's immune system responds and to check for any side effects. Participants will receive a flu jab and attend clinic visits for blood tests, which measure the protective proteins (antibodies) made by the body. They will also track how they feel using a digital diary for the first week. Taking part helps doctors find better ways to protect older people from serious winter illnesses.
At a glance
What is this study about?
Influenza is a common chest and throat infection that spreads easily during the winter months. While flu can make anyone feel unwell, it poses a much higher risk of serious chest infections and hospital stays for older adults. Over time, the immune system naturally becomes slower at responding to standard vaccines, meaning older people often need a stronger boost to stay protected.
To solve this, researchers have developed 'high-dose' flu vaccines. These jabs contain higher levels of the harmless flu virus parts, giving the body a clearer signal to build strong defences. This clinical trial is testing Abbott's new high-dose vaccine to find out if it produces a reliable immune response against three common types of flu virus.
During the trial, doctors will compare the new vaccine against approved flu jabs. They will check blood samples taken about four weeks after vaccination to count the protective antibodies in the bloodstream. They will also track safety carefully, watching for typical side effects like a tender arm or a mild fever.
By taking part, volunteers help medical researchers confirm whether this new vaccine is safe and effective. If successful, it could offer doctors and healthcare systems like the NHS another powerful tool to keep older adults healthy and out of hospital each winter.
Key takeaways
- Tests a new high-dose flu jab designed to give stronger protection to older adults.
- Every participant receives a genuine flu vaccine; nobody receives a dummy jab.
- Involves a single jab, short daily diary entries for one week, and blood tests to check antibody levels.
- Safety and health are monitored by doctors for up to six months.
- Participation is completely voluntary and will not affect your regular NHS medical care.
Who may be eligible?
This study is designed for adults, with a particular focus on people aged 60 and older. Both men and women can join. Because the study looks at how older immune systems react, having common, well-managed age-related health conditions usually will not stop you from taking part.
To join, you must be able to attend the planned clinic visits and agree to follow the study steps, which include having blood tests and logging your daily symptoms on a digital diary for a short time.
You may not be able to take part if you have had a severe allergic reaction to a flu vaccine in the past, or if you have an active illness with a high fever on the day of vaccination. The study doctor will check your medical history to make sure taking part is safe for you.
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.
- I am an adult (the study focuses on people aged 60 and over).
- I have not had a severe allergic reaction to a flu vaccine in the past.
- I am willing to receive a flu injection and have routine blood samples taken.
- I can use a simple digital app to record my daily symptoms for one week.
- I am able to attend clinic visits over a period of up to six months.
What does participation involve?
Taking part in the study lasts up to six months and involves several key steps:
• Vaccine injection: You will receive a single flu jab at the study clinic. Everyone in this study receives an active flu vaccine; no dummy jabs (placebos) are used. • Daily health diary: For the first seven days after your injection, you will use a simple digital diary (eDiary) on a smartphone or handheld device to note down any mild symptoms, such as arm soreness, tiredness, or a mild temperature. • Clinic visits and blood tests: You will visit the clinic for health checks and blood samples. A key blood test takes place about 28 days after your jab to measure your body's immune response. Some participants may receive a follow-up booster jab and further blood tests. • Long-term safety follow-up: The research team will keep in touch with you for up to six months to ensure you remain well and to record any health changes.
Potential risks and benefits
Locations (5)
- —UnverifiedSpain
- —UnverifiedBulgaria
- —UnverifiedEstonia
- —UnverifiedFinland
- —UnverifiedBelgium
Common questions
Could I receive a dummy jab (placebo) instead of a real flu vaccine?
No. This trial uses active controls, meaning every volunteer receives a real, working flu jab designed to protect against the flu.
Can the trial vaccine give me the flu?
No. The vaccine uses inactivated (killed) parts of the virus. It cannot multiply or cause an active flu infection in your body.
Will taking part cost me anything?
No. The study vaccine, tests, and medical visits are provided free of charge. Most studies also help cover reasonable travel expenses to and from the clinic.
What is an eDiary and how do I use it?
An eDiary is an easy-to-use app on a mobile device where you answer a few quick questions each evening for seven days about how you feel and whether your arm is sore.
Can I still get my normal NHS flu jab if I join?
Because you will already receive an active flu vaccine in this trial, you will not usually need another flu jab that same season. You should discuss this with the study team and your GP.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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