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

Completed · Phase 3 · Has a placebo group

Conditions studied: Meningococcal Vaccine

In brief

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.

Key facts

Study ID

NCT04440163

Run by

Pfizer

People needed

2431

Starts

2020-06-17

Expected to finish

2022-07-24

Last updated by the study team

2023-04-18

Who can join

Age: 10 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subject aged >=10 and <26 years at the time of randomization.
• Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
• Negative urine pregnancy test for all female subjects.
• ACWY-naïve participants: Participants who have never received a prior dose of a meningococcal vaccine containing ACWY serogroups.
• ACWY-experienced participants: Participants who have received not more than 1 prior dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.

You may not qualify if…

• Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine.- Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
• A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
• Significant neurological disorder or history of seizure (excluding simple febrile seizure).
• Current chronic use of systemic antibiotics.
• Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
• Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
• History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
• Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.

Where it is running

• Central Research Associates, Inc. — Birmingham, Alabama, United States
• Fiel Family and Sports Medicine, PC/CCT Research — Tempe, Arizona, United States
• Velocity Clinical Research (Banning) — Banning, California, United States
• Madera Family Medical Group — Madera, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Center for Clinical Trials — Paramount, California, United States
• Optumcare Colorado Springs, LLC — Colorado Springs, Colorado, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• Alliance for MultiSpecialty Research, LLC - Miami — Coral Gables, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Altus Research — Lake Worth, Florida, United States
• Acevedo Clinical Research Associates — Miami, Florida, United States
• Healthy Life Research, Inc. — Miami, Florida, United States
• Bio-Medical Research, LLC — Miami, Florida, United States
• Crystal Biomedical Research, LLC — Miami Lakes, Florida, United States
• San Marcus Research Clinic, Inc. — Miami Lakes, Florida, United States
• Complete Health Research — Ormond Beach, Florida, United States
• Oviedo Medical Research, LLC — Oviedo, Florida, United States
• PAS Research — Tampa, Florida, United States
• Tekton Research, Inc. — Chamblee, Georgia, United States
• Velocity Clinical Research - Boise — Meridian, Idaho, United States
• Saltzer Health — Nampa, Idaho, United States
• MOC Research — Mishawaka, Indiana, United States
• The South Bend Clinic Center for Research — South Bend, Indiana, United States
• Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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