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

Completed · Phase 2 · Has a placebo group

Conditions studied: Meningococcal Vaccine

In brief

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.

Key facts

Study ID

NCT04440176

Run by

Pfizer

People needed

309

Starts

2020-06-17

Expected to finish

2024-01-05

Last updated by the study team

2026-04-27

Who can join

Age: 11 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• AMR Clinical — Mobile, Alabama, United States
• California Research Foundation — San Diego, California, United States
• Nona Pediatric Center — Orlando, Florida, United States
• Velocity Clinical Research, Norfolk — Norfolk, Nebraska, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Ohio Pediatric Research Association Inc. — Dayton, Ohio, United States
• Coastal Carolina Research Center — North Charleston, South Carolina, United States
• Benchmark Research — Fort Worth, Texas, United States
• Texas Health Resources — Fort Worth, Texas, United States
• Diagnostics Research Group — San Antonio, Texas, United States
• Wee Care Pediatrics — Kaysville, Utah, United States
• Wasatch Pediatrics, Cottonwood Office — Murray, Utah, United States
• Utah Valley Pediatrics - Timpanogos Office — Orem, Utah, United States
• AMR Clinical — Roy, Utah, United States
• J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah, United States
• J. Lewis Research, Inc. / Foothill Family Clinic South — Salt Lake City, Utah, United States
• AMR Clinical — South Jordan, Utah, United States
• Wee Care Pediatrics — Syracuse, Utah, United States
• Pediatric Research of Charlottesville, LLC — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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