A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Assess the Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningococcal B Recombinant Vaccine and the Response to a Third Dose in Adolescents and Young Adult Subjects Who Previously Participated in Parent Studies V72_41 (NCT01423084) and V72P10 (NCT00661713), Compared to Naïve Healthy Controls

Trial Profile

A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Assess the Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningococcal B Recombinant Vaccine and the Response to a Third Dose in Adolescents and Young Adult Subjects Who Previously Participated in Parent Studies V72_41 (NCT01423084) and V72P10 (NCT00661713), Compared to Naïve Healthy Controls

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2017

At a glance

  • Drugs Meningococcal vaccine group B OMV Novartis (Primary)
  • Indications Meningococcal group B infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors GlaxoSmithKline; Novartis Vaccines
  • Most Recent Events

    • 08 Oct 2017 Results assessing persistence of bactericidal activity at 4 years presented at the IDWeek 2017
    • 30 Nov 2016 Status changed from recruiting to completed.
    • 15 Mar 2016 Planned primary completion date changed from 1 Aug 2016 to 1 Jul 2016 as per ClinicalTrials.gov record.
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