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Safety and immunogenicity study of Pentavalent Meningococcal ABCYW vaccine (MenPenta SD and MenPenta fHD) compared to licensed meningococcal vaccines in infants, toddlers and children

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What is this trial about?

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

This clinical trial aims to evaluate the safety and effectiveness of a new vaccine called MenPenta for preventing meningococcal disease. This vaccine targets five different types of meningococcal bacteria (groups A, B, C, W, and Y) that can cause serious infections of the brain and spinal cord lining. The study will compare the new vaccine with currently approved meningococcal vaccines.

The research involves three different age groups: children aged 2 to 9 years, toddlers aged 12 to 15 months, and infants aged 2 months. Some participants will receive the new MenPenta vaccine alone, while others will receive it along with standard childhood vaccines. The study will monitor how well the immune system responds to the vaccine and track any side effects that may occur.

During the study, participants will receive multiple doses of vaccines through intramuscular injection. Blood samples will be taken to measure the body's immune response to the vaccines. The researchers will carefully monitor all participants for immediate reactions after vaccination and continue to track their health throughout the study period. Other routine vaccines that may be given during the study include Prevenar 13 (for protection against pneumococcal disease), Hexyon (a combination vaccine that protects against six different diseases), and RotaTeq (for protection against rotavirus).

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial vaccination visit

    Your participation begins with receiving the first dose of the meningococcal vaccine.

    The vaccine will be administered as an injection into the muscle.

    A physical examination and health assessment will be performed to ensure you meet the health requirements.

  2. Step 2

    Monitoring period after first dose

    You will need to stay at the clinic for observation after receiving the vaccine.

    The medical team will monitor for any immediate reactions to the vaccine.

    You will receive instructions on how to track and report any side effects that may occur after leaving the clinic.

  3. Step 3

    Second vaccination visit

    The second dose of the vaccine will be administered approximately 30 days after the first dose.

    Blood samples will be collected to measure your immune response to the vaccine.

    Another physical examination will be performed before administering the second dose.

  4. Step 4

    Final follow-up visit

    A final visit will occur 30 days after the second vaccination.

    Blood samples will be taken to measure the final immune response.

    A complete health assessment will be performed to document any changes since the start of the study.

  5. Step 5

    Safety monitoring

    Throughout the study period, any health changes or side effects should be recorded.

    The study team will monitor your health and safety through regular assessments.

    The total duration of participation will be approximately 60-90 days.

Who can join the trial?

10 criteria

  • Must be between 2 to 9 years old (Stage 1), 12 to 15 months old (Stage 2), or 56 to 89 days old (Stage 3) on the day of joining the study
  • For infants and toddlers, must meet one of these birth conditions:
    • Born at full term (37 weeks or more of pregnancy) with birth weight of at least 2.5 kg
    • Born between 28 and 36 weeks of pregnancy with birth weight of at least 1.5 kg
    • Infants born early (premature) must be medically stable, meaning they:
      • Do not need significant medical support
      • Do not have ongoing serious health conditions
      • Have shown steady health improvement before first vaccine dose
      • Must be in good overall health, as determined by:
        • Medical history review
        • Physical examination
        • Doctor's assessment
        • Both males and females can participate

Who cannot join the trial?

12 criteria

  • Prior history of meningococcal disease (an infection that causes inflammation of the protective membranes covering the brain and spinal cord)
  • Previous vaccination with any meningococcal vaccine
  • Known allergies to any vaccine components
  • Currently participating in another clinical trial or received an investigational product within the past 30 days
  • Any confirmed or suspected immunosuppressive condition (weakened immune system)
  • History of chronic medical conditions that could interfere with the study results
  • Fever (temperature ≥38.0°C/100.4°F) within 3 days before vaccination
  • Receipt of blood products or immunoglobulins (antibody preparations) within the past 3 months
  • Any serious medical condition that could interfere with study procedures
  • History of severe allergic reactions to any substance
  • Currently taking medications that could affect immune response
  • Any bleeding disorders or conditions that increase risk of bleeding
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Investigated drugs

  • MenPenta

    (Pentavalent Meningococcal ABCYW Vaccine) is an investigational vaccine designed to protect against five different types of meningococcal bacteria (serogroups A, B, C, W-135, and Y). This vaccine aims to prevent meningococcal disease, which can cause serious infections like meningitis and sepsis.

  • Routine pediatric vaccines

    are standard childhood immunizations that are typically given according to recommended vaccination schedules. These vaccines protect against various common childhood diseases and are being studied when given together with the MenPenta vaccine in toddlers and infants.

  • Licensed meningococcal vaccines

    are currently approved vaccines that protect against meningococcal disease. These are being used as comparison vaccines to evaluate how well the new MenPenta vaccine works. These existing vaccines may protect against one or more types of meningococcal bacteria, but not necessarily all five types that MenPenta targets.

What is already known about the treatment

MenPenta - A pentavalent meningococcal vaccine (ABCYW) that is currently being studied in clinical trials for the prevention of meningococcal disease. This investigational vaccine is administered through intramuscular injection and is being evaluated in different age groups, including infants (2 months), toddlers (12-15 months), and children (2-9 years). The vaccine is designed to provide protection against five major serogroups of Neisseria meningitidis (A, B, C, W-135, and Y) by stimulating the immune system to produce protective antibodies against these bacterial strains. As a combination vaccine, it represents a potential advancement in meningococcal disease prevention by offering broader protection compared to currently available vaccines while potentially reducing the number of required injections.

Investigated diseases

Meningococcal Disease - A bacterial infection caused by Neisseria meningitidis that can affect the protective membranes covering the brain and spinal cord. The disease can develop rapidly, typically beginning with symptoms similar to a cold or flu, such as fever and headache. It can spread through close contact with respiratory secretions from infected individuals. The bacteria can cause both meningitis (infection of the brain and spinal cord membranes) and septicemia (blood infection). Different serogroups (A, B, C, W-135, and Y) of the bacteria can cause the disease. The infection primarily affects infants, young children, and adolescents.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2023-510465-10-00Protocol codeVAN00013Estimated enrolment750 patientsSponsorSanofi Pasteur Inc.

sourced from the EU Clinical Trials Register and site verification

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