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.
Phase of Trial: Phase III
Latest Information Update: 29 Aug 2016
At a glance
- Drugs DTP-hepatitis B vaccine (Primary)
- Indications Hepatitis B
- Focus Pharmacodynamics
- 06 Jul 2010 New trial record