Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

Sanofi

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Meningococcal Immunization; Healthy Volunteers

Treatments: Biological: Pneumococcal 13-valent conjugate vaccine; Biological: MenACYW conjugate vaccine; Biological: DTap-HepB-IPV-Hib vaccine; Drug: Paracetamol; Biological: Pentavalent Meningococcal ABCYW vaccine; Biological: Meningococcal group B vaccine; Biological: Rotavirus vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06647407

VAN00013 (Other Identifier)

2023-510465-10 (Registry Identifier)

Details and patient eligibility

About

This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 56 days to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion
• 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

Participants are excluded from the study if any of the following criteria apply:

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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750 participants in 9 patient groups

Stage 1: MenPenta vaccine formulation 1

Experimental group

Description:

MenPenta vaccine formulation 1, children 2-9 years of age

Treatment:

Biological: Pentavalent Meningococcal ABCYW vaccine

Stage 1: MenPenta vaccine formulation 2

Experimental group

Description:

MenPenta vaccine formulation 2, children 2-9 years of age

Treatment:

Biological: Pentavalent Meningococcal ABCYW vaccine

Stage 1: vaccine comparator(s)

Active Comparator group

Description:

Comparator vaccines: Bexsero + MenQuadfi, children 2-9 years of age

Treatment:

Biological: Meningococcal group B vaccine

Biological: MenACYW conjugate vaccine

Biological: MenACYW conjugate vaccine

Stage 2: MenPenta vaccine formulation 1

Experimental group

Description:

MenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age

Treatment:

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pentavalent Meningococcal ABCYW vaccine

Drug: Paracetamol

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: DTap-HepB-IPV-Hib vaccine

Stage 2: MenPenta vaccine formulation 2

Experimental group

Description:

MenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age

Treatment:

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pentavalent Meningococcal ABCYW vaccine

Drug: Paracetamol

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: DTap-HepB-IPV-Hib vaccine

Stage 2: vaccine comparator(s)

Active Comparator group

Description:

Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age

Treatment:

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Meningococcal group B vaccine

Biological: MenACYW conjugate vaccine

Drug: Paracetamol

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: MenACYW conjugate vaccine

Biological: DTap-HepB-IPV-Hib vaccine

Stage 3: MenPenta vaccine formulation 1

Experimental group

Description:

MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age

Treatment:

Biological: Rotavirus vaccine

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pentavalent Meningococcal ABCYW vaccine

Drug: Paracetamol

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: DTap-HepB-IPV-Hib vaccine

Stage 3: MenPenta vaccine formulation 2

Experimental group

Description:

MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age

Treatment:

Biological: Rotavirus vaccine

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pentavalent Meningococcal ABCYW vaccine

Drug: Paracetamol

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: DTap-HepB-IPV-Hib vaccine

Stage 3: vaccine comparator(s)

Active Comparator group

Description:

Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age

Treatment:

Biological: Rotavirus vaccine

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Meningococcal group B vaccine

Biological: MenACYW conjugate vaccine

Drug: Paracetamol

Biological: DTap-HepB-IPV-Hib vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: MenACYW conjugate vaccine

Biological: DTap-HepB-IPV-Hib vaccine