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Study on the Safety and Immune Response of MenABCWY Vaccine and Drug Combination in Healthy Infants with Meningococcal Infections

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 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 new vaccine called MenABCWY, which is designed to protect against several groups of the bacteria that cause these infections. The trial will also involve other vaccines, including MenB and MenACWY-TT, to compare their effectiveness and safety. The purpose of the study is to evaluate how safe these vaccines are and how well they work in producing an immune response in healthy infants.

Participants in the study will receive the vaccines as injections. The study will monitor the infants over a period of time to observe any reactions to the vaccines and to measure the immune response. This will help determine how well the vaccines protect against the different groups of the bacteria. The study will also include a comparison with a placebo to ensure the results are accurate.

The trial will take place over several months, with multiple visits for vaccinations and follow-up checks. The researchers will collect data on any side effects and the overall health of the participants. This information will be used to assess the safety and effectiveness of the vaccines in preventing meningococcal infection in infants. The study aims to provide valuable insights into the best ways to protect against this serious disease.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant's parent or legally acceptable representative provides written or witnessed consent. This consent is necessary before any study-specific procedures begin.

    The participant is confirmed to be healthy through a medical history review and clinical examination.

  2. Step 2

    First vaccination

    The participant receives the first dose of the MenABCWY-2nd Gen vaccine or another study vaccine. This is administered as an injection.

    The participant is monitored for any immediate reactions to the vaccine.

  3. Step 3

    Monitoring after first vaccination

    For 7 days following the first vaccination, the participant is observed for any local or systemic reactions at the injection site.

    For 30 days after the vaccination, any unexpected adverse events, including those requiring medical attention, are recorded.

  4. Step 4

    Second vaccination

    The participant receives a second dose of the study vaccine approximately 91 days after the first vaccination.

    The participant is again monitored for any immediate reactions to the vaccine.

  5. Step 5

    Monitoring after second vaccination

    For 7 days following the second vaccination, the participant is observed for any local or systemic reactions at the injection site.

    For 30 days after the vaccination, any unexpected adverse events, including those requiring medical attention, are recorded.

  6. Step 6

    Third vaccination

    The participant receives a third dose of the study vaccine approximately 301 days after the first vaccination.

    The participant is monitored for any immediate reactions to the vaccine.

  7. Step 7

    Monitoring after third vaccination

    For 7 days following the third vaccination, the participant is observed for any local or systemic reactions at the injection site.

    For 30 days after the vaccination, any unexpected adverse events, including those requiring medical attention, are recorded.

  8. Step 8

    Final assessment

    The participant's immune response to the vaccines is assessed through blood tests conducted at specified intervals.

    The study concludes with a final assessment of the participant's health and any long-term effects of the vaccinations.

Who can join the trial?

5 criteria

  • The participant's parent(s) or Legally Acceptable Representative(s) (LAR(s)) must be able and willing to follow the study requirements, as judged by the study doctor.
  • Written or witnessed/thumb printed informed consent must be obtained from the parent(s) or LAR(s) before any study-specific procedures are done. Informed consent means they agree to the participant being in the study after understanding all the details.
  • The participant must be healthy, as determined by their medical history and a physical examination before joining the study.
  • The participant must be a male or female who is between 55 and 89 days old (about 2 months old) at the time of the first study vaccination.
  • The participant must have been born after a pregnancy lasting at least 37 weeks and must have had a birth weight of at least 2.5 kg.

Who cannot join the trial?

8 criteria

  • Patients with any current or past **infections** caused by **meningococcal bacteria** cannot participate. Meningococcal bacteria can cause serious illnesses like meningitis.
  • Patients who have received any **meningococcal vaccines** in the past cannot participate. These vaccines are used to protect against infections caused by meningococcal bacteria.
  • Patients with any known **allergies** to the components of the study vaccines cannot participate. An allergy is when your body reacts negatively to a substance.
  • Patients with any **immune system disorders** cannot participate. The immune system is the body's defense against infections and diseases.
  • Patients who are currently participating in another **clinical trial** cannot participate. A clinical trial is a research study to test new treatments.
  • Patients who are pregnant or breastfeeding cannot participate. Pregnancy is the period when a woman carries a developing fetus, and breastfeeding is feeding a baby with milk from the breast.
  • Patients with any serious **chronic illnesses** cannot participate. Chronic illnesses are long-lasting health conditions that require ongoing medical attention.
  • Patients who have received any **blood products** in the past 3 months cannot participate. Blood products are components derived from blood, like plasma or red blood cells.
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Investigated drugs

  • MenABCWY-2nd Gen vaccine

    is a new version of a vaccine designed to protect against meningococcal disease, which is a serious infection caused by bacteria. This vaccine targets multiple strains of the bacteria, specifically serogroups A, B, C, W, and Y. The goal of this vaccine is to help the body build immunity, which means it trains the immune system to recognize and fight off these bacteria if they are encountered in the future.

  • MenABCWY-1st Gen vaccine

    is an earlier version of the meningococcal vaccine that also aims to protect against the same serogroups: A, B, C, W, and Y. Like the 2nd Gen version, it helps the immune system learn how to defend against these bacteria, reducing the risk of developing meningococcal disease.

  • MenB vaccine

    is specifically designed to protect against serogroup B of the meningococcal bacteria. This vaccine helps the immune system recognize and fight off this particular strain, which is one of the causes of meningococcal disease.

  • MenACWY-TT vaccine

    is another type of meningococcal vaccine that targets serogroups A, C, W, and Y. It works by helping the immune system prepare to fight these specific strains of bacteria, thereby reducing the risk of infection and serious illness.

What is already known about the treatment

  • MenABCWY-2nd Gen vaccine

    This vaccine is administered through an injection and is currently being studied in clinical trials to evaluate its safety and effectiveness in healthy infants. It is designed to protect against infections caused by the meningococcal bacteria, specifically targeting serogroups A, B, C, W, and Y. The vaccine works by stimulating the immune system to produce antibodies that can recognize and fight off these bacteria. It is classified as a meningococcal vaccine and is part of ongoing research to improve protection against meningococcal infections.

  • MenABCWY-1st Gen vaccine

    Administered via injection, this vaccine is also under investigation in clinical trials to assess its safety and immune response in infants. It aims to prevent infections from meningococcal bacteria, focusing on serogroups A, B, C, W, and Y. The mechanism involves prompting the immune system to generate protective antibodies against these bacteria. It falls under the category of meningococcal vaccines and is being studied to enhance meningococcal disease prevention.

  • MenB vaccine

    This vaccine is given through an injection and is being evaluated in clinical trials for its safety and ability to provoke an immune response in infants. It specifically targets serogroup B of the meningococcal bacteria, helping the body to produce antibodies that can defend against this type of infection. It is classified as a meningococcal vaccine and is part of efforts to improve protection against meningococcal serogroup B infections.

  • MenACWY-TT vaccine

    Administered by injection, this vaccine is included in clinical trials to determine its safety and effectiveness in infants. It is designed to protect against meningococcal infections caused by serogroups A, C, W, and Y. The vaccine works by encouraging the immune system to create antibodies that can fight these bacteria. It is categorized as a meningococcal vaccine and is being researched to enhance the prevention of infections from these specific serogroups.

Investigated diseases

Meningococcal Infections – Meningococcal infections are caused by the bacterium Neisseria meningitidis. These infections can lead to serious conditions such as meningitis, which is the inflammation of the protective membranes covering the brain and spinal cord. The disease often begins with symptoms like sudden fever, headache, and a stiff neck. As it progresses, individuals may experience nausea, vomiting, increased sensitivity to light, and confusion. The bacteria can also cause bloodstream infections, leading to symptoms such as fatigue, cold hands and feet, chills, severe aches or pain in the muscles, joints, chest, or abdomen, and a rapid breathing rate. If not addressed, the infection can spread rapidly, affecting multiple organs.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2023-506449-40-00Protocol code217043Estimated enrolment703 patientsSponsorGlaxoSmithKline Biologicals

sourced from the EU Clinical Trials Register and site verification

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