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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: Completed Phase 3 study of Meningococcal Vaccine, sponsored by Pfizer.

NCT04440163 is a Phase 3 study of Meningococcal Vaccine that has completed, run by Pfizer. The registered enrollment target is 2,431 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (215% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than \[\<\] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (\>=) 1:16; 2) baseline hSBA titer \>=LOD and \< lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer \>=4 times LLOQ; 3) baseline hSBA titer \>=LLOQ, 4-fold rise was defined as hSBA titer \>=4 times baseline titer. Exact 2-sided confidence inte

Conditions Studied

Meningococcal Vaccine

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
Pfizer

1,845 total trials

What the finished NCT04440163 record still lists

NCT04440163 is an interventional study that assigns participants to a tested intervention. Its 2,431 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (215% higher).

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 names 20 study sites across 5 states, led by 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.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT04440163's enrollment target sits among peer trials

2,431 88th of 2000 higher than 1,912 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04440163, the US trial registry maintained by the National Library of Medicine. NCT04440163 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.