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A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

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Trial Profile

A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jun 2023

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At a glance

  • Drugs Meningococcal vaccine group B OMV Novartis (Primary) ; Hib-DTaP-hepatitis B-poliovirus vaccine; Meningococcal vaccine group C conjugate; Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal group B infections; Pertussis; Poliomyelitis; Tetanus
  • 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.
    • 19 Jan 2013 Results for the immunogencity and safety substudies in the primary phase and for the booster study published in the Lancet.
    • 01 Mar 2012 Actual patient number is 3600 as reported by EudraCT (Extension trial: EudraCT2008-006301-17).

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