A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
Condition: Vaccines; Meningococcal Vaccines
Intervention: rLP2086 + MCV4 + Tdap; MCV4 + Tdap + saline; rLP2086 + saline
Intervention description: At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.; At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.; At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2648.0
Sex: All
Minimum age: 10 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; rLP2086; MCV4; Tdap; meningitis B; N. meningitidis serogroup B; adolescents; observer-blind

Summary:

      This is a clinical study to assess the safety, tolerance and immunogenic response to
      MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and
      W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine.
      Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized
      into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to
      all injections given throughout the study. An unblinded administrator will be responsible to
      administer the vaccinations to all subjects and will be unblinded to the subject
      randomization in order to determine which subjects were in randomized to group 3 so they may
      receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be
      conducted with all subjects 6-months post their last vaccination to obtain safety
      information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of a personally signed and dated informed consent document (ICD) indicating
             that the subject (and a legally authorized representative) has been informed of all
             pertinent aspects of the study.

          -  Parent /legally authorized representative and subjects who are willing and able to
             comply with scheduled visits, laboratory tests, and other study procedures.

          -  Male or female subject aged greater than or equal to 10 and <13 years at the time of
             enrollment.

          -  Available for the entire study period and can be reached by telephone.

          -  Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

          -  Has received full series (5-dose series is preferred, 4-dose catch up series is
             allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per
             country specific recommendations applicable at the time of receipt.

          -  Male and female subjects of childbearing potential must agree to use a highly
             effective method of contraception throughout the study.

        Exclusion Criteria:

          -  Previous vaccination with any meningococcal serogroup B vaccine.

          -  Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the
             first study vaccination.

          -  Previous vaccination with any MCV4 vaccine.

          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Contraindication to vaccination with MCV4 and/or Tdap 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.

          -  Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          -  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 with
             terminal complement deficiency may not be included.

          -  History of culture-proven disease caused by Neisseria meningitidis or Neisseria
             gonorrhoea.

          -  Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

          -  Receipt of any blood products, including immunoglobulin within 6 months before the
             first study vaccination.

          -  Current chronic use of systemic antibiotics.

          -  Any neuroinflammatory or autoimmune condition, including, but not limited to,
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.