Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents

Sanofi

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Meningococcal Infection; Healthy Volunteers; Meningococcal Immunisation

Treatments: Biological: Pentavalent Meningococcal ABCYW vaccine; Biological: MenABCYW conjugate vaccine; Biological: MenACYW conjugate vaccine; Biological: Placebo; Biological: Meningococcal group B vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06128733

U1111-1272-6824 (Registry Identifier)

VAN00010

2023-000924-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents.

The study duration will be up to 12 months for all participants.

Full description

The study duration will be approximately 12 months for all participants

Enrollment: 1,220 estimated patients

Sex: All

Ages: 10 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Aged 18 to 25 years or 10 to 17 years on the day of inclusion

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator.
• Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
• Known or suspected congenital or acquired immunodeficiency
• History of any Neisseria meningitidis infection
• At high risk for meningococcal infection during the study
• Individuals with active tuberculosis
• History of Guillain-Barré syndrome
• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion 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: Triple Blind

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1,220 participants in 7 patient groups

Group 1: MenPenta Formulation 1

Experimental group

Description:

Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo

Treatment:

Biological: Placebo

Biological: Pentavalent Meningococcal ABCYW vaccine

Group 2: MenPenta Formulation 2

Experimental group

Description:

Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo

Treatment:

Biological: Placebo

Biological: Pentavalent Meningococcal ABCYW vaccine

Group 3: Bexsero® + Menveo®

Active Comparator group

Description:

Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine

Treatment:

Biological: Meningococcal group B vaccine

Biological: MenACYW conjugate vaccine

Biological: MenACYW conjugate vaccine

Biological: Meningococcal group B vaccine

Biological: Meningococcal group B vaccine

Group 4: Trumenba® + Menveo®

Active Comparator group

Description:

Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine

Treatment:

Biological: Meningococcal group B vaccine

Biological: MenACYW conjugate vaccine

Biological: MenACYW conjugate vaccine

Biological: Meningococcal group B vaccine

Biological: Meningococcal group B vaccine

Group 5: MenQuadfi®

Active Comparator group

Description:

Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo

Treatment:

Biological: MenACYW conjugate vaccine

Biological: Placebo

Biological: MenACYW conjugate vaccine

Group 6: Sanofi MenB

Experimental group

Description:

Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo

Treatment:

Biological: Meningococcal group B vaccine

Biological: Placebo

Biological: Meningococcal group B vaccine

Biological: Meningococcal group B vaccine

Group 7: PENBRAYA

Active Comparator group

Description:

Participants (ACWY naive and primed adults or adolescents) will receive injections of PENBRAYA vaccine and placebo

Treatment:

Biological: MenABCYW conjugate vaccine