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A Phase 3, Open label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13 [EXTENSTION OF 700033114]

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Trial Profile

A Phase 3, Open label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13 [EXTENSTION OF 700033114]

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2016

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At a glance

  • Drugs Meningococcal vaccine group B OMV Novartis (Primary) ; MMR-varicella zoster virus vaccine
  • Indications Chickenpox; Measles; Meningococcal group B infections; Mumps; Rubella
  • Focus 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.
    • 05 Mar 2015 New source identified and integrated (ClinicalTrials.gov record: NCT00847145)
    • 21 Jan 2013 New trial record
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