A prospective, multicentre, comparative, open label, randomised phase III study to assess immunogenicity and safety of LBVF0101 {DTwP-HB-Hib (combined vaccine which is reconstituted from LBVW0101 (Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) just before intramuscular injection} compared with combined vaccine which is reconstituted from Tritanrix HBÂ(Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and Hiberix (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) just before intramuscular injection in healthy infants at six, ten and fourteen weeks of age.

Trial Profile

A prospective, multicentre, comparative, open label, randomised phase III study to assess immunogenicity and safety of LBVF0101 {DTwP-HB-Hib (combined vaccine which is reconstituted from LBVW0101 (Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) just before intramuscular injection} compared with combined vaccine which is reconstituted from Tritanrix HBÂ(Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and Hiberix (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) just before intramuscular injection in healthy infants at six, ten and fourteen weeks of age.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2016

At a glance

  • Drugs Hib DTP hepatitis B vaccine (Euforvac-Hib) (Primary) ; Hib-DTP hepatitis B vaccine (Tritanrix-HepB/Hiberix)
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors LG Life Sciences
  • Most Recent Events

    • 21 Jan 2011 Status changed from active, no longer recruiting to completed as reported by Clinical Trials Registry - India.
    • 15 Jun 2010 Status changed from recruiting to active, no longer recruiting as reported by Clinical Trials Registry - India.
    • 12 Feb 2010 New trial record
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