A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules

A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE

This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.

Inclusion Criteria:

• Male or female participants 11 through <15 years of age at the time of randomization.
• Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization.
• Available for the entire study period and can be reached by telephone.
• Healthy participant as determined by medical history, physical examination, and judgement of the investigator.
• Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.

Exclusion Criteria:

• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• 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 participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy.
• History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
• Significant neurological disorder or history of seizure (excluding simple febrile seizure).
• Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
• Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
• Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
• Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).