A Phase 3, Randomized, Active-controlled, Observer-blinded Trial to Assess the Lot Consistency, Safety, Tolerability, and Immunogenicity of a Meningococcal Serogroup B Bivalent rLP2086 Vaccine in Healthy Subjects Aged greater than or equal to 10 to less than 19 Years

Trial Profile

A Phase 3, Randomized, Active-controlled, Observer-blinded Trial to Assess the Lot Consistency, Safety, Tolerability, and Immunogenicity of a Meningococcal Serogroup B Bivalent rLP2086 Vaccine in Healthy Subjects Aged greater than or equal to 10 to less than 19 Years

Completed
Phase of Trial: Phase III

Latest Information Update: 30 May 2017

At a glance

  • Drugs PF 5212366 (Primary) ; Hepatitis A vaccine inactivated
  • Indications Meningococcal group B infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • 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.
    • 13 May 2016 The results from this an another phase III trial (see CT profile 700198643) support additional upcoming global regulatory submissions and the planned US supplement to request the conversion of Accelerated Approval to Traditional Approval for TRUMENBA, according to a Pfizer media release.
    • 13 May 2016 Results from this trial were presented at the 34th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID 2016), according to a Pfizer media release.
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