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A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls

Trial Profile

A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2018

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At a glance

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

    • 01 Aug 2018 Results (n=239) published in the Pediatrics.
    • 22 Mar 2015 Status changed from active, no longer recruiting to completed, according to to ClinicalTrials.gov record.
    • 06 Jan 2015 Status changed from recruiting to active, no longer recruiting, according to ClinicalTrial.gov record.
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