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Demonstrate non-inferiority of GSK Biologicals' Tritanrix-HepB/Hib-MenAC vs Tritanrix-HepB/Hiberix with respect to anti-HBs immune response, when given to healthy infants at 6, 10 and 14 wks age, after a birth dose of hepatitis B vaccine

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Trial Profile

Demonstrate non-inferiority of GSK Biologicals' Tritanrix-HepB/Hib-MenAC vs Tritanrix-HepB/Hiberix with respect to anti-HBs immune response, when given to healthy infants at 6, 10 and 14 wks age, after a birth dose of hepatitis B vaccine

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2022

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At a glance

  • Drugs Hib-DTP-hepatitis B-meningococcal vaccine groups A and C conjugate (Primary) ; Hib-DTP hepatitis B vaccine (Tritanrix-HepB/Hiberix); Meningococcal vaccine groups A C Y W-135 polysaccharide
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal infections; Pertussis; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 30 Sep 2011 Actual initiation date (April 2006) added as reported by ClinicalTrials.gov.
    • 09 Oct 2008 Trial centres updated from NCT.
    • 09 Oct 2008 Checked against ClinicalTrials.gov record - last updated 9 Oct 2008.
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