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A Phase 2, Randomized, Active-Controlled, Observer-Blinded Trial to Assess the Safety, Tolerability and Immunogenicity of MCV4, Tdap Vaccine and Bivalent rLP2086 Vaccine When Administered Concomitantly in Healthy Subjects Aged > = to 10 Years to Less Than 13 Years.

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Trial Profile

A Phase 2, Randomized, Active-Controlled, Observer-Blinded Trial to Assess the Safety, Tolerability and Immunogenicity of MCV4, Tdap Vaccine and Bivalent rLP2086 Vaccine When Administered Concomitantly in Healthy Subjects Aged > = to 10 Years to Less Than 13 Years.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs DTaP vaccine (Primary) ; Meningococcal vaccine group B (Primary) ; Meningococcal vaccine groups A C Y W-135 conjugate
  • Indications Diphtheria; Meningococcal group A infections; Meningococcal group C infections; Meningococcal group W-135 infections; Meningococcal group Y infections; Pertussis; Tetanus
  • Focus Pharmacodynamics
  • Sponsors Pfizer
  • Most Recent Events

    • 30 May 2017 According to a Pfizer media release, the European Commission (EC) has approved TRUMENBA (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older. Results from this study supported the approval.
    • 11 Mar 2016 Results published in the Pediatric Infectious Disease Journal
    • 09 Oct 2015 Results presented at IDWeek 2015, according to a Pfizer media release.

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