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A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
Sponsor: Pfizer
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
11 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
309
Start Date
2020-06-17
Completion Date
2024-01-05
Last Updated
2026-04-27
Healthy Volunteers
Yes
Conditions
Interventions
MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
Saline
Placebo
Locations (20)
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