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An open, controlled, randomized, comparative, phase IIIb study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine [Twinrix (at least 720 EL.U of hepatitis A antigen and 20 microg of hepatitis B surface antigen per mL)] given on an accelerated schedule (0, 7, and 21 to 30 days followed by a booster at month 12), compared to separate vaccinations with GlaxoSmithKline Biologicals' monovalent hepatitis A vaccine (Havrix, at least 1440 EL.U/1 mL) given on a 0, 12-month schedule and hepatitis B vaccine (Engerix-B, 20 microg /1 ml) given on a 0, 1, 2, 12-month schedule) in healthy adults 18 years of age or older

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Trial Profile

An open, controlled, randomized, comparative, phase IIIb study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine [Twinrix (at least 720 EL.U of hepatitis A antigen and 20 microg of hepatitis B surface antigen per mL)] given on an accelerated schedule (0, 7, and 21 to 30 days followed by a booster at month 12), compared to separate vaccinations with GlaxoSmithKline Biologicals' monovalent hepatitis A vaccine (Havrix, at least 1440 EL.U/1 mL) given on a 0, 12-month schedule and hepatitis B vaccine (Engerix-B, 20 microg /1 ml) given on a 0, 1, 2, 12-month schedule) in healthy adults 18 years of age or older

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Aug 2023

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At a glance

  • Drugs Hepatitis A-hepatitis B vaccine (Primary) ; Hepatitis A vaccine inactivated; Hepatitis B vaccine recombinant
  • Indications Hepatitis A; Hepatitis B
  • Focus Pharmacodynamics; Therapeutic Use
  • Sponsors GlaxoSmithKline

    • Most Recent Events

    • 03 Nov 2006 New trial record.
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