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

  • STATUS
    Recruiting
  • participants needed
    2413
  • sponsor
    Pfizer
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Updated on 5 August 2020
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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-nave and ACWY-experienced healthy participants 10 to <26 years of age.

Details
Condition Meningococcal Polysaccharide Vaccine
Age 10years - 25years
Treatment Saline, MenABCWY, Trumenba, MenACWY-CRM
Clinical Study IdentifierNCT04440163
SponsorPfizer
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

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-nave 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 Criteria

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
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