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A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years

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Trial Profile

A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2018

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At a glance

  • Drugs Meningococcal vaccine group B (Primary) ; Hepatitis A vaccine inactivated
  • Indications Hepatitis A; Meningococcal group B infections
  • Focus Adverse reactions; Registrational
  • Sponsors Pfizer

Most Recent Events

  • 23 Apr 2018 According to Pfizer media release, the company received traditional approval for TRUMENBA (Meningococcal Group B Vaccine) from the FDA in individuals 10 to 25 years of age for the three-dose schedule based data from this study.
  • 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.
  • 01 Feb 2016 Results published in the Vaccine

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