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Study on the Safety and Immune Response of a Booster Dose of MenACYW Conjugate Vaccine in Children and Adolescents Previously Vaccinated for Meningococcal Infection

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What is this trial about?

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

This clinical trial is focused on studying a disease called meningococcal infection, which is caused by bacteria that can lead to serious illnesses like meningitis. The study is testing a vaccine called MenQuadfi, which is a solution for injection designed to protect against four groups of the bacteria: A, C, W, and Y. The vaccine works by using a protein called tetanus toxoid to help the body recognize and fight off these bacteria.

The purpose of the study is to evaluate how well the MenQuadfi vaccine works and how safe it is when given as a booster dose to children and adolescents. These participants had previously received the vaccine as toddlers. The study will look at how the immune system responds to the booster dose and how long the protection lasts. Participants will receive the vaccine through an injection into the muscle, and the study will monitor their immune response over time.

Throughout the study, researchers will collect information on the participants' immune responses to the vaccine and any side effects they may experience. This will help determine the effectiveness of the booster dose in maintaining protection against meningococcal infection. The study aims to provide valuable insights into the long-term benefits of the MenQuadfi vaccine in preventing serious bacterial infections in children and adolescents.

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 visit
Upon joining the study, the participant will attend an initial visit. During this visit, the participant will receive a booster dose of the MenQuadfi solution for injection, which is a vaccine designed to protect against meningococcal infection. This vaccine is administered as an intramuscular injection.
The participant will be monitored for any immediate reactions to the injection. This monitoring is part of ensuring the safety and effectiveness of the vaccine.
Step 2
Follow-up visits
The participant will attend several follow-up visits over the course of the study. These visits are scheduled to assess the participant's immune response to the vaccine and to monitor for any side effects.
During these visits, blood samples may be taken to measure antibody levels against the meningococcal serogroups A, C, W, and Y. This helps in understanding how well the vaccine is working.
Step 3
Monitoring and reporting
Throughout the study, the participant will be asked to report any side effects or health changes. This information is crucial for evaluating the safety of the vaccine.
The participant will also be monitored for any adverse events, which are any unexpected medical issues that occur during the study.
Step 4
Final assessment
At the end of the study period, a final assessment will be conducted. This will include a review of the participant's health and any changes that have occurred since the start of the study.
The final assessment will help determine the long-term effectiveness and safety of the booster dose of the MenQuadfi vaccine.

Who can join the trial?

4 criteria

Must have received the MenACYW vaccine in a previous study called MET51 and completed that study by attending all required visits.
The participant and their parent or legally acceptable representative must be able to attend all scheduled visits and follow all trial procedures.
Must have health insurance if it is required by local regulations.
An Assent Form (AF) must be signed and dated by the participant, if applicable. An Informed Consent Form (ICF) must be signed and dated by the parent(s) or another legally acceptable representative, and by an independent witness if required by local regulations.

Who cannot join the trial?

6 criteria

Participants who have not received the MenACYW conjugate vaccine approximately 5 or 10 years earlier as toddlers or children.
Participants who have not been part of the MET51 study.
Participants who have not received a booster dose of the MenACYW conjugate vaccine approximately 5 years earlier.
Participants who are not within the age range specified for the study.
Participants who are not able to comply with the study procedures.
Participants with any medical condition that, in the opinion of the study doctor, makes it unsafe for them to participate.

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Verified sites

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

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Verified
Rokotetutkimuskeskus Finvac Oy
Tampere, Finland

Trial locations

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Investigated drugs

MenACYW Conjugate Vaccine is a vaccine designed to protect against four types of bacteria that can cause meningitis, known as meningococcal serogroups A, C, W, and Y. In this clinical trial, the vaccine is being studied to see how well it works and how safe it is when given as a booster dose to children and adolescents. These participants had previously received the vaccine when they were toddlers. The study aims to understand how long the protection from the initial vaccination lasts and how the immune system responds to additional booster doses. This vaccine helps the body build a defense against these bacteria, reducing the risk of getting sick from meningitis.

What is already known about the treatment

MenACYW Conjugate Vaccine – This vaccine is administered as an injection to help protect against meningococcal infections, which are serious bacterial infections that can lead to conditions like meningitis. Currently, the vaccine is being studied in clinical trials to assess its effectiveness and safety when given as a booster dose to children and adolescents who were previously vaccinated as toddlers. The main purpose of the vaccine is to boost the immune system's ability to fight off meningococcal bacteria, specifically targeting serogroups A, C, W, and Y. It works by introducing small, harmless pieces of the bacteria to the body, which helps the immune system recognize and respond more effectively if exposed to the actual bacteria in the future. This vaccine is classified as a conjugate vaccine, which means it is designed to improve the immune response by linking the bacterial pieces to a protein.

Investigated diseases

Meningococcal infection – Meningococcal infection is caused by the bacterium Neisseria meningitidis, which can lead to serious illnesses such as meningitis and septicemia. The bacteria are transmitted through respiratory droplets and can colonize the nasopharynx. In some cases, the bacteria invade the bloodstream and spread to the brain and spinal cord, causing inflammation of the protective membranes. Symptoms may include sudden fever, headache, stiff neck, nausea, vomiting, increased sensitivity to light, and confusion. The disease can progress rapidly, and early symptoms may resemble those of the flu. It is important to monitor for any signs of severe illness, as the condition can escalate quickly.