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COMPLETED
NCT04440176
PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

MenABCWY

Neisseria meningitidis group A, B, C, W, and Y vaccine

BIOLOGICAL

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