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A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents

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Trial Profile

A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs Meningococcal vaccine groups A C Y W-135 conjugate (Primary) ; DTaP vaccine; Human papillomavirus vaccine recombinant quadrivalent Merck
  • Indications Meningitis; Meningococcal 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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