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

NCT04440163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2431

Last updated 2023-04-18

Study results available
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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

  • Meningococcal Vaccine

Interventions

BIOLOGICAL

MenABCWY

N meningitidis groups A, B, C, W, and Y vaccine

BIOLOGICAL

Saline

Placebo

BIOLOGICAL

Trumenba

Bivalent recombinant lipoprotein 2086 vaccine

BIOLOGICAL

MenACWY-CRM

Meningococcal group A, C, W-135, and Y conjugate vaccine

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2022-07-24
Completion
2022-07-24
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Denmark
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440163 on ClinicalTrials.gov