Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3b, open-label, multi-center study to assess the immune response and safety of the meningococcal group B vaccine rMenB+OMV NZ when administered to healthy participants aged 10 to 20 years old, who were primed during the first 2 years of life

This research study is for healthy young people aged 10 to 20 years old who received their first meningitis B (MenB) vaccinations when they were babies. The study aims to understand how well a booster dose of the MenB vaccine, called Bexsero, can protect them against meningitis B and to make sure it's safe. Meningitis B is a serious illness, and vaccines help prevent it. By taking part, volunteers will receive a booster dose of the MenB vaccine. Researchers will then check their immune response (how well their body fights off the disease) and monitor for any side effects. The study will look at these effects over about a month.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

247

Start

11 Aug 2025

Invasive meningococcal disease (IMD)

What is this study about?

This study is designed to help us better understand a vaccine called Bexsero, which protects against a serious illness called Meningitis B. Meningitis B is an infection that can cause swelling around the brain and spinal cord, and it can be very dangerous. Many babies in the UK receive the Bexsero vaccine as part of their routine immunisation schedule.

This particular study focuses on young people aged 10 to 20 years old who had their first Meningitis B vaccinations when they were infants. As children grow older, the protection from baby vaccines can sometimes lessen over time. This study wants to see if giving a booster dose of the Bexsero vaccine to these young people can help strengthen their immune system's ability to fight off Meningitis B again.

The main goal is to check how strong the immune response is after this booster dose and to carefully record any side effects to make sure the vaccine is still safe for this age group. By doing this research, we can gather important information that helps doctors and public health experts make decisions about the best ways to protect young people from Meningitis B in the long term.

Key takeaways

This study looks at a Meningitis B vaccine (Bexsero) in young people.
It's for those aged 10-20 who had the vaccine as babies.
The goal is to check how well the booster dose works and if it's safe.
Participation involves one vaccine, two visits, and blood tests over a month.
It could help improve long-term protection against Meningitis B.

Who may be eligible?

This study is looking for healthy young people who are aged between 10 and 20 years old. An important requirement is that you must have received your initial Meningitis B vaccinations when you were a baby (before you were two years old).

If you have certain serious ongoing health conditions or are allergic to any vaccine ingredients, you might not be able to join. The study team will review your medical history carefully to make sure it's safe for you to take part.

Quick self-check

Are you between 10 and 20 years old?
Did you receive your first Meningitis B vaccinations when you were a baby (under two years old)?
Are you generally healthy?
Are you able to attend two study visits over approximately one month?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive a single injection of the Bexsero vaccine. After the vaccination, you would be asked to keep track of any side effects you might experience for about a week. You would also have two study visits, one at the very start (Day 1) and another visit about a month later (Day 31). At these visits, a small blood sample would be taken to check your immune response. The total time you would be in the study, from your first visit to your last, would be around 31 days. Throughout this time, the study team would be available to answer any questions and monitor your well-being.

Potential risks and benefits

Taking part in this study could help us learn more about how to protect young people from Meningitis B, which benefits public health. You would also receive a booster dose of the Meningitis B vaccine. However, there are potential side effects, similar to any vaccine, such as soreness or redness at the injection site, headache, or feeling a bit unwell. These are usually mild and temporary. More severe reactions are rare, but the study team will monitor you closely. Remember, you can choose to leave the study at any time and for any reason without it affecting your medical care.

Locations (3)

—
Italy
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Finland
—
Spain

Common questions

What is Meningitis B?

Meningitis B is a serious bacterial infection that can cause inflammation of the brain and spinal cord. It can lead to severe complications or even be life-threatening if not treated quickly.

Why is this study only for people who had the vaccine as babies?

This study wants to see if a booster vaccination helps keep up the protection in young people who were already vaccinated against Meningitis B when they were very young.

What is Bexsero?

Bexsero is the specific brand of vaccine used to help protect against Meningitis B.

Will I get paid to take part?

The study information will detail if there is any payment for your time or reimbursement for travel expenses. This varies between studies.

How long will I be in the study?

The study involves about a month (31 days) from your first visit to your final visit, with one vaccination and two blood tests.