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NCT04440163 · ClinicalTrials.gov registry record · Phase 3

MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

A Phase 3 study of Meningococcal Vaccine, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
2,431
Enrollment target
20
Study locations

NCT04440163 is a Phase 3 study of Meningococcal Vaccine that has completed, run by Pfizer. The registered enrollment target is 2,431 participants. The trial reports 20 study locations across 5 states.

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The verdict

NCT04440163, a Phase 3 study of Meningococcal Vaccine, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
2,431 participants
Enrollment target
20
Study locations

Study Summary

The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to \<26 years of age.

Conditions Studied

Interventions

  • BIOLOGICAL Saline
  • BIOLOGICAL Trumenba
  • BIOLOGICAL MenACWY-CRM
  • BIOLOGICAL MenABCWY

Study Locations (20)

Florida

  • ALL Medical Research, LLC - Cooper City
  • Alliance for MultiSpecialty Research, LLC - Miami - Coral Gables
  • Health Awareness, Inc. - Jupiter
  • Altus Research - Lake Worth
  • Acevedo Clinical Research Associates - Miami
  • Healthy Life Research, Inc. - Miami
  • Bio-Medical Research, LLC - Miami
  • Crystal Biomedical Research, LLC - Miami Lakes
  • San Marcus Research Clinic, Inc. - Miami Lakes
  • Complete Health Research - Ormond Beach
  • Oviedo Medical Research, LLC - Oviedo
  • PAS Research - Tampa

California

  • Velocity Clinical Research (Banning) - Banning
  • Madera Family Medical Group - Madera
  • Center for Clinical Trials, LLC - Paramount
  • Center for Clinical Trials - Paramount

Alabama

  • Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites - Birmingham
  • Central Research Associates, Inc. - Birmingham

Arizona

  • Fiel Family and Sports Medicine, PC/CCT Research - Tempe

Colorado

  • Optumcare Colorado Springs, LLC - Colorado Springs

Trial Details

FieldValue
Enrollment Target 2,431 participants
Start Date 2020-06-17
Est. Completion 2022-07-24
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT04440163

The ClinicalTrials.gov registry entry for NCT04440163 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,431 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Meningococcal Vaccine appearing as the primary indexed condition, and to 4 interventions - of which Saline is the first listed.

NCT04440163 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT04440163 about?

NCT04440163 is a clinical study titled "MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age". The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to \<26 years of age.

What is the current status of trial NCT04440163?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,431 participants. The study started on 2020-06-17. Estimated completion is 2022-07-24.

What conditions does trial NCT04440163 study?

This clinical trial studies the following conditions: Meningococcal Vaccine.

What interventions are being tested in trial NCT04440163?

The interventions under investigation include: Saline (BIOLOGICAL), Trumenba (BIOLOGICAL), MenACWY-CRM (BIOLOGICAL), MenABCWY (BIOLOGICAL).

Who is sponsoring clinical trial NCT04440163?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04440163 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.