A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

Trial Profile

A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2017

At a glance

  • Drugs Meningococcal vaccine group B OMV Novartis (Primary) ; Meningococcal vaccine group C conjugate; Pneumococcal 10-valent vaccine conjugate
  • Indications Meningococcal group B infections
  • Focus Pharmacodynamics
  • Sponsors Novartis Vaccines
  • Most Recent Events

    • 15 Mar 2017 Results published in the Vaccine
    • 13 May 2016 Results published in a GlaxoSmithKline media release.
    • 13 May 2016 Primary endpoint (Immune response of rMenB+OMV NZ (defined as 70% for the lower limit of the two-sided 97.5% CI for the percentage of subjects achieving hSBA titers of at least 4 for all 3 indicator strains)) has been met, according to a GlaxoSmithKline media release.
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