Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
NCT ID: NCT06647407
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
750 participants
INTERVENTIONAL
2024-11-05
2027-05-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Study details include:
The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
* Laboratory personnel will be blinded to the treatment assignment
* Participants, Investigators, and Site staff preparing and administering the study intervention will be unblinded between the MenPenta and comparator groups but will be blinded between the 2 MenPenta groups The Sponsor will be partially blinded. At the time of periodic data reviews, additional measures are put in place to maintain the blind of the study participants for the Sponsor staff. The data review will be conducted on the basis of blinded outputs (where data of the 2 MenPenta groups and the control group will be reviewed in aggregate, without any distinction by group). By design, the Sponsor team will have access to partially blinded data for individual participants (eg, for assessment of SAE)
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stage 1: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1, children 2-9 years of age
Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Stage 1: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2, children 2-9 years of age
Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Stage 1: vaccine comparator(s)
Comparator vaccines: Bexsero + MenQuadfi, children 2-9 years of age
MenACYW conjugate vaccine
Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM)
Meningococcal group B vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Stage 2: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age
Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Paracetamol
Pharmaceutical form:Suspension-Route of administration:oral
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Pneumococcal 13-valent conjugate vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Stage 2: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age
Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Paracetamol
Pharmaceutical form:Suspension-Route of administration:oral
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Pneumococcal 13-valent conjugate vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Stage 2: vaccine comparator(s)
Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age
MenACYW conjugate vaccine
Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM)
Meningococcal group B vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Paracetamol
Pharmaceutical form:Suspension-Route of administration:oral
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Pneumococcal 13-valent conjugate vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Stage 3: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age
Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Paracetamol
Pharmaceutical form:Suspension-Route of administration:oral
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Oral solution in tube Route of administration: oral
Rotavirus vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Pneumococcal 13-valent conjugate vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Stage 3: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age
Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Paracetamol
Pharmaceutical form:Suspension-Route of administration:oral
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Oral solution in tube Route of administration: oral
Rotavirus vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Pneumococcal 13-valent conjugate vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Stage 3: vaccine comparator(s)
Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age
MenACYW conjugate vaccine
Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM)
Meningococcal group B vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Paracetamol
Pharmaceutical form:Suspension-Route of administration:oral
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Oral solution in tube Route of administration: oral
Rotavirus vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Pneumococcal 13-valent conjugate vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
MenACYW conjugate vaccine
Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM)
MenACYW conjugate vaccine
Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM)
Meningococcal group B vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Paracetamol
Pharmaceutical form:Suspension-Route of administration:oral
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine
Pharmaceutical form: Oral solution in tube Route of administration: oral
Rotavirus vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Pneumococcal 13-valent conjugate vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 Kg and in both cases medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the investigator
Exclusion Criteria
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months or since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants)
* History of any meningitis infection, confirmed either clinically, serologically, or microbiologically
* At high risk of meningococcal infection during the study
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
* Individual with active tuberculosis
* History of Guillain-Barré syndrome
* For Stage 3 infants: History of intussusception
* Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine
* For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
56 Days
9 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital das Clínicas da Universidade Federal de Minas Gerais- Site Number : 0760001
Belo Horizonte, Minas Gerais, Brazil
Private Practice - Dr. Nelson Rosário- Site Number : 0760004
Curitiba, Paraná, Brazil
Investigational Site Number : 2030003
Jindřichův Hradec, , Czechia
Investigational Site Number : 2030004
Ostrava, , Czechia
Investigational Site Number : 2030007
Pilsen, , Czechia
Investigational Site Number : 2030008
Prague, , Czechia
Investigational Site Number : 2030009
Prague, , Czechia
Investigational Site Number : 2080002
Hvidovre, , Denmark
Investigational Site Number : 2080003
Odense, , Denmark
Investigational Site Number : 2460006
Espoo, , Finland
Investigational Site Number : 2460001
Helsinki, , Finland
Investigational Site Number : 2460008
Helsinki, , Finland
Investigational Site Number : 2460005
Järvenpää, , Finland
Investigational Site Number : 2460004
Oulu, , Finland
Investigational Site Number : 2460002
Seinäjoki, , Finland
Investigational Site Number : 2460007
Tampere, , Finland
Investigational Site Number : 2760008
Herxheim, , Germany
Investigational Site Number : 2760006
Hürth, , Germany
Investigational Site Number : 2760007
Hürth, , Germany
Investigational Site Number : 2760005
Krefeld, , Germany
Investigational Site Number : 2760009
Mönchengladbach, , Germany
Investigational Site Number : 2760004
Schönau am Königssee, , Germany
Investigational Site Number : 2760003
Wolfsburg, , Germany
Investigational Site Number : 3400001
San Pedro Sula, , Honduras
Investigational Site Number : 3400002
Tegucigalpa, , Honduras
Investigational Site Number : 3400003
Tegucigalpa, , Honduras
Investigational Site Number : 6160006
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160005
Trzebnica, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160001
Lodz, Lódzkie, Poland
Investigational Site Number : 6160003
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160002
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160004
Siemianowice Śląskie, Silesian Voivodeship, Poland
Investigational Site Number : 7240007
Seville, Sevilla, Spain
Investigational Site Number : 7240009
Madrid, , Spain
Investigational Site Number : 7240004
Madrid, , Spain
Investigational Site Number : 8260004
Exeter, Devon, United Kingdom
Investigational Site Number : 8260007
London, England, United Kingdom
Investigational Site Number : 8260009
London, England, United Kingdom
Investigational Site Number : 8260010
Southampton, Hampshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
Access external resources that provide additional context or updates about the study.
VAN00013 Plain Language Results Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-510465-10
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAN00013
Identifier Type: -
Identifier Source: org_study_id