Not recruiting

Study of rMenB+OMV NZ meningococcal group B vaccine immune response and safety in previously vaccinated healthy participants aged 10 to 20 years

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial evaluates the immune response to Bexsero, a vaccine against invasive meningococcal disease caused by group B bacteria. The study focuses on individuals aged 10 to 20 years who previously received this vaccine in early childhood. Meningococcal disease is a serious infection that can cause inflammation of the membranes surrounding the brain and spinal cord.

The vaccine is given as a suspension for intramuscular injection using a pre-filled syringe. Each participant will receive one dose of 0.5 milliliters of the vaccine. The study compares the immune response between people who received the vaccine in early childhood and those who have never received it before.

The main purpose is to determine if people previously vaccinated with Bexsero show a stronger immune response to a booster dose compared to those receiving the vaccine for the first time. The study will monitor participants for 31 days after vaccination to assess both the immune response and safety of the vaccine.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination visit (Day 1)
You will receive a Bexsero vaccine through an injection in your muscle.
If you are a female of childbearing age, a pregnancy test will be performed.
Blood samples will be collected to measure your immunity levels against meningococcal B bacteria.
You will receive a diary to record any reactions at the injection site or other symptoms for the next 7 days.
Step 2
7-day monitoring period
Record any injection site reactions (such as pain, redness, or swelling) in your diary.
Document any general symptoms like fever, headache, or muscle pain.
Note any other health changes you experience.
Step 3
Follow-up visit (Day 31)
Return to the study site for a final visit.
Blood samples will be collected to measure your immunity levels against meningococcal B bacteria.
The study team will review your diary and any health changes you experienced.
This visit concludes your participation in the study.
Step 4
Safety monitoring
The study team will monitor for any serious health events throughout the entire study period.
Special attention will be paid to monitoring for arthritis as a specific safety concern.
Any significant health events will be followed up until resolved.

Who can join the trial?

11 criteria

Age requirement: Must be between 10 and 20 years old at the time of first study treatment
Previous vaccination status must be either:
- Previously received meningococcal B vaccine in early childhood (with documented proof), or
- Never received any meningococcal B vaccine (with documented proof)
- Must be able to follow study requirements and attend follow-up visits
- Must provide written informed consent:
  - Ages 10-16: Both parent/guardian and participant must provide consent
  - Ages 16/18-20: Participant can provide consent independently
  - For female participants:
    
    Can participate if not able to bear children (before first menstrual period, surgical procedures preventing pregnancy), or
    If able to bear children, must:
    
    Use effective birth control for 1 month before study
    Have negative pregnancy test before treatment
    Agree to continue birth control throughout study
    Must have proper documentation of vaccination history (electronic or paper records)

Who cannot join the trial?

14 criteria

History of meningococcal disease (an infection that causes inflammation of the protective membranes covering the brain and spinal cord)
Previous severe allergic reaction to any vaccine components
Currently participating in another clinical trial
Any serious chronic medical condition that could interfere with the study
Received any vaccine within 30 days before the study
Current fever or acute illness
Pregnancy or breastfeeding
Known or suspected immune system disorders
History of seizures or neurological conditions
Blood clotting disorders or regular use of blood thinners
Taking medications that affect the immune system
History of fainting with vaccine administration
Unable to complete all required study visits
Any condition that, in the opinion of the study doctor, would make participation unsafe

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero-Universitaria Maggiore Della Carita
Verified
Novara, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Verified
Milan, Italy
IRCCS Ospedale Policlinico San Martino
Verified
Genoa, Italy

Trial locations

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Investigated drugs

rMenB+OMV NZ is a vaccine designed to protect against meningococcal group B disease, which is a serious bacterial infection that can cause meningitis and blood poisoning. This vaccine contains proteins from meningococcal bacteria combined with outer membrane vesicles (OMV) from New Zealand strain. It helps the body's immune system recognize and fight against the bacteria that cause meningococcal B disease. The vaccine is given as an injection and works by stimulating the immune system to produce antibodies against the bacteria.

What is already known about the treatment

rMenB+OMV NZ - A recombinant meningococcal group B vaccine administered via intramuscular injection, developed to prevent invasive meningococcal disease (IMD). This vaccine combines recombinant meningococcal B proteins with outer membrane vesicles from New Zealand strain (OMV NZ), providing targeted protection against meningococcal B bacteria. The vaccine works by stimulating the immune system to produce antibodies against specific proteins found on the surface of meningococcal bacteria, creating a protective immune response that can prevent future infections. It belongs to the class of bacterial vaccines and is particularly significant in protecting adolescents and young adults who were previously vaccinated in early childhood.

Investigated diseases

Invasive Meningococcal Disease (IMD) - A bacterial infection caused by Neisseria meningitidis that can spread through the bloodstream and affect various organs. The disease typically begins with flu-like symptoms, including fever, headache, and neck stiffness. As the infection progresses, it can cause inflammation of the membranes surrounding the brain and spinal cord. The condition can develop rapidly, sometimes within hours, and may be accompanied by a distinctive rash. IMD can affect people of any age, though it occurs more frequently in young children and adolescents.