A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years
Condition: Meningococcal Vaccine
Intervention: rLP2086; rLP2086; rLP2086; Havrix (HAV); Saline
Intervention description: 0.5 mL dose, given at 0, 2 and 6 months (lot 1); 0.5 mL dose, given at 0, 2 and 6 months (lot 2); 0.5 mL dose, given at 0, 2 and 6 months (lot 3); 0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.; 0.5 mL dose of sterile normal saline for injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3596.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is looking at a new vaccine that might prevent meningococcal disease, and will
      study whether healthy adolescent subjects receiving different lots of vaccine respond in a
      similar way. The study will also look at the safety of the new vaccine as well as how it is
      tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject aged >=10 and <19 years at the time of enrollment.

          2. Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

          3. Negative urine pregnancy test for all female subjects.

        Exclusion Criteria:

          1. Previous vaccination with any meningococcal serogroup B vaccine.

          2. Subjects who have received prior HAV vaccination.

          3. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a
             3-dose series during the period between Visit 1 and 28 days after the second
             vaccination.

          4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
             allergen immunotherapy with a licensed product and are not on stable maintenance
             doses.

          5. 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.

          6. Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

          7. Current chronic use of systemic antibiotics.

          8. Received any investigational vaccines, drugs, or devices within 28 days before
             administration of the first study vaccination.

          9. Any neuroinflammatory or autoimmune condition, including, but not limited to,
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.