A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

Trial Profile

A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

Completed
Phase of Trial: Phase II

Latest Information Update: 26 Jul 2016

At a glance

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

    • 12 Apr 2016 Results (pooled analysis of this and other three studies) assessing whether pooled-sera hSBA titres predict individual seroprotection published in the Vaccine.
    • 13 Oct 2012 New source identified and integrated (second extension study: EudraCT2011-004931-30).
    • 28 Apr 2012 Planned patient number of extension trial (EudraCT2009-011676-30) changed from 1587 to 1900.
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