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A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar

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Trial Profile

A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 May 2022

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At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hepatitis B vaccine recombinant; Hib-DTaP-poliovirus vaccine; Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Sanofi; Sanofi Pasteur

    • Most Recent Events

    • 27 Nov 2018 Result analysis from NCT00362427 , NCT01337167 , NCT01340937, NCT01341639 , NCT01480258 , NCT01553279 , providing a comprehensive safety profile, published in the Pediatric Infectious Disease Journal.
    • 01 Jan 2014 Results published in the Pediatric Infectious Disease Journal.
    • 02 Mar 2010 Actual patient number chnaged from 459 to 460 as reported by ClinicalTrials.gov.

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