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Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers

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Trial Profile

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Meningococcal vaccine groups A C Y W-135 conjugate (Primary) ; Hib-DTaP-hepatitis B-poliovirus vaccine; Measles mumps and rubella virus vaccine; Pneumococcal 13-valent CRM197 vaccine conjugate; Varicella zoster virus vaccine live
  • Indications Meningococcal group A infections; Meningococcal group C infections; Meningococcal group W-135 infections; Meningococcal group Y infections
  • 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.
    • 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
    • 22 Sep 2020 According to a Sanofi media release, the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for 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.The recommendation is supported by seven Phase 2 and 3 clinical studies
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