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A prospective, multicentre, comparative, double blind, randomized phase III study to assess immunogenicity and safety of LBVW0101 (Diphtheria-Tetanus-whole cell Pertussis- Hepatitis B) compared with Tritanrix HB (Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and to demonstrate the equivalence of three different lots of LBVW0101, in terms of immunogenicity, in healthy infants at six, ten, and fourteen weeks of age.

Trial Profile

A prospective, multicentre, comparative, double blind, randomized phase III study to assess immunogenicity and safety of LBVW0101 (Diphtheria-Tetanus-whole cell Pertussis- Hepatitis B) compared with Tritanrix HB (Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and to demonstrate the equivalence of three different lots of LBVW0101, in terms of immunogenicity, in healthy infants at six, ten, and fourteen weeks of age.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Aug 2016

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At a glance

  • Drugs DTP-hepatitis B vaccine (Primary)
  • Indications Hepatitis B
  • Focus Pharmacodynamics
  • Sponsors LG Life Sciences
  • Most Recent Events

    • 06 Jul 2010 New trial record
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