Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents, to Evaluate Safety, Tolerability and Immunogenicity of Four Different rMenB Plus MenACWY Formulations.

Trial Profile

Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents, to Evaluate Safety, Tolerability and Immunogenicity of Four Different rMenB Plus MenACWY Formulations.

Completed
Phase of Trial: Phase II

Latest Information Update: 06 Oct 2013

At a glance

  • Drugs Meningococcal vaccine group B (Primary) ; Meningococcal vaccine groups A B C Y W-135 conjugate (Primary) ; Meningococcal vaccine groups A C Y W-135 conjugate
  • Indications Meningococcal group A infections; Meningococcal group B infections; Meningococcal group C infections; Meningococcal group W-135 infections; Meningococcal group Y infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Novartis; Novartis Vaccines
  • Most Recent Events

    • 02 May 2012 Actual patient number of the extension trial (NCT01367158) changed from 456 to 440.
    • 02 May 2012 Status of the extension trial (NCT01367158) changed from recruiting to active, no longer recruiting.
    • 26 Dec 2011 Actual patient number amended from 480 to 456 as reported by ClinicalTrials.gov. (Extension trial: NCT01367158).
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