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

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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

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

Trial contacts and locations

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Central trial contact

Trial Transparency email recommended (Toll free for US & Canada)

Data sourced from clinicaltrials.gov

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