MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
Condition: Meningococcal Vaccine
Intervention: MenABCWY; Saline; Trumenba; MenACWY-CRM
Intervention description: N meningitidis groups A, B, C, W, and Y vaccine; Placebo; Bivalent recombinant lipoprotein 2086 vaccine; Meningococcal group A, C, W-135, and Y conjugate vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2431.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed
      vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of
      MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10
      to <26 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject aged >=10 and <26 years at the time of randomization.

          -  Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

          -  Negative urine pregnancy test for all female subjects.

          -  ACWY-naïve participants: Participants who have never received a prior dose of a
             meningococcal vaccine containing ACWY serogroups.

          -  ACWY-experienced participants: Participants who have received not more than 1 prior
             dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.

        Exclusion Criteria:

          -  Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide
             (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine.-
             Subjects receiving any allergen immunotherapy with a non-licensed product or receiving
             allergen immunotherapy with a licensed product and are not on stable maintenance
             doses.

          -  A known or suspected defect of the immune system that would prevent an immune response
             to the vaccine, such as subjects with congenital or acquired defects in B cell
             function, those receiving chronic systemic (oral, intravenous, or intramuscular)
             corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the
             United States with terminal complement deficiency are excluded from participation in
             this study.

          -  Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

          -  Current chronic use of systemic antibiotics.

          -  Participation in other studies involving investigational drug(s) or investigational
             vaccine(s) within 28 days prior to study entry and/or during study participation.

          -  Any neuroinflammatory or autoimmune condition, including, but not limited to,
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

          -  History of microbiologically proven disease caused by N meningitidis or Neisseria
             gonorrhoeae.

          -  Receipt of any blood products, including immunoglobulin, within 6 months before the
             first study vaccination.