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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jan 2007

At a glance

  • Drugs Hepatitis A vaccine inactivated; Hepatitis A-hepatitis B vaccine; 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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