Status:
COMPLETED
MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
Lead Sponsor:
Pfizer
Conditions:
Meningococcal Vaccine
Eligibility:
All Genders
10-25 years
Phase:
PHASE3
Brief 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 c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2022
Estimated Enrollment :
2431 Patients enrolled
Trial Details
Trial ID
NCT04440163
Start Date
June 17 2020
End Date
July 24 2022
Last Update
April 18 2023
Active Locations (78)
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1
Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites
Birmingham, Alabama, United States, 35205
2
Central Research Associates, Inc.
Birmingham, Alabama, United States, 35205
3
Fiel Family and Sports Medicine, PC/CCT Research
Tempe, Arizona, United States, 85283
4
Velocity Clinical Research (Banning)
Banning, California, United States, 92220