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

CompletedPhase 2

Sponsor: Pfizer

Conditions: Meningococcal Vaccine

Interventions: MenABCWY, Saline

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 11 Years to 14 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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).

Locations (20)

Mobile, Alabama, United States
San Diego, California, United States
Orlando, Florida, United States
Norfolk, Nebraska, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
North Charleston, South Carolina, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Kaysville, Utah, United States
Murray, Utah, United States
Orem, Utah, United States
Roy, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
Syracuse, Utah, United States
Charlottesville, Virginia, United States