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Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years

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Trial Profile

Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2020

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At a glance

  • Drugs Meningococcal vaccine groups A C Y W-135 conjugate (Primary)
  • Indications Meningococcal group A infections; Meningococcal group C infections; Meningococcal group W-135 infections; Meningococcal group Y infections; Meningococcal meningitis
  • Focus Pharmacodynamics; Registrational
  • Sponsors Sanofi Pasteur

    • Most Recent Events

    • 23 Nov 2020 According to a Sanofi media release, based on the seven pivotal Phase 2 and 3 studies (NCT02955797, NCT03077438, NCT02199691, NCT02842866, NCT02752906, NCT02842853, NCT03205371), the European Commission (EC) has approved MenQuadfi for active immunization of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.
    • 25 Oct 2020 Results of pooled analysis of data from 5 pivotal randomized trials assessing structured benefit-risk analysisfor MenACYW-TT presented at the IDWeek 2020
    • 22 Sep 2020 According to a Sanofi media release, Following this CHMP positive opinion, a final decision is anticipated by the end of this year. MenQuadfi is expected to be gradually available in Europe starting in 2021.

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