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

2 1 1 1

What is this study about?

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).

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
Kinderpneumologische Praxis Dr. Funck Neuss Germany
Kinder- und Jugendärzte Hürth- Park, Dr. med. Ludwig Stapenhorst Hürth Germany
Kinderarztpraxis Leyental Krefeld Germany
Pediatrie Slunicko s.r.o. Prague Czechia
Rokotetutkimuskeskus Finvac Oy Tampere Finland
Instituto Hispalense De Pediatria S.L. Sevilla Spain
Detska doktorka Plzen s.r.o. Plzen Czechia
Kinderarztpraxis Ralph Köllges Moenchengladbach Germany

Other Sites

Site Name City Country Status
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Amager Hospital Copenhagen Denmark
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Rybarczyk I Partnerzy Spolka Lekarska sp.p. Siemianowice Slaskie Poland
Hospital 9 De Octubre S.A. Valencia Spain
Hospital Universitario Hm Puerta Del Sur Mostoles Spain
Odense University Hospital Odense Denmark
Universidade De Santiago De Compostela Santiago De Compostela Spain
In Vivo Sp. z o.o. Bydgoszcz Poland
Region Midtjylland Aarhus Denmark
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Region Sjaelland Holbæk Denmark
Pfndupq Pornusmqlpc Sau z oheg Warsaw Poland
Oalszf od Dzl mtum Amqvhoe Potvb Hürth Germany
Wjwkoal -bwj Pqxnx fmr Kmzohxv uoq Jmzrfdawlnsuv Wolfsburg Germany
Poxvnn Dph Kk Jljnkb Herxheim Germany
Puxrpvcaa Jpnvcnkrej stleau Prague Czechia
Nbjnidzzggix sqnmmj Ostrava Czechia
Stdkzsn Itd Sfr Jytnjqx Srukopyo W Thtigntus Szbtmfnmnsj Pfnfwcidt Zspjsf Orthak Zvphsoimbf Trzebnica Poland
Mmweagho Hzqbbxqj Helsinki Finland
Kwtfnlqlgacizrue Dii mwcs Mqdwlvr Hyrs Schonau Germany
Gfdyqvf Duagisdnzsr I Lbgnvdfy Npgearlffkkv Lodz Poland
Fuixkzcps Pfde Lg Itpyelghrgmsn Baxdwhics Dna Hwveeknr Uszkzrbmwnoqg Ly Pmm Madrid Spain
Moois Dxeuaxd Vdnwlermat Mak Jindřichův Hradec Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
08.01.2025
Denmark Denmark
Not recruiting
08.01.2025
Finland Finland
Not recruiting
08.01.2025
Germany Germany
Not recruiting
08.01.2025
Poland Poland
Not recruiting
08.01.2025
Spain Spain
Not recruiting
08.01.2025

Trial locations

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.

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 ID:
2023-510465-10-00
Protocol code:
VAN00013
Trial Phase:
Therapeutic exploratory (Phase II)

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