Combined diphtheria-tetanus-whole cell pertussis, hepatitis B vaccine(KFT) has been approved in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Combined diphtheria-tetanus-whole cell pertussis, hepatitis B vaccine (KFT) studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
102144(DTPwCSL-HBVGOD-004) III A phase III, partially single blind, multicentric clinical study to assess the immunogenicity and reactogenicity of a booster dose of GSK Biologicals Kft’s combined DTPwCSL-HB vaccine as compared to concomitant administration of CSL’s DTPw (Triple Antigen™) vaccine and GSK Biologicals’ hepatitis B (Engerix™-B) vaccine at separate injection sites and to GSK Biologicals’ DTPw-HB (Tritanrix™-HepB) vaccine, when administered to healthy infants at 12 to 18 months of age, who were primed in the primary vaccination study 196131/001. DTPwCSL-HB (DTPwCSL-HBV): GSK Biologicals Kft’s combined diphtheria, tetanus, whole cell Bordetella pertussis vaccine with the Pw component produced by Commonwealth Serum Laboratory and the D and T components produced by GSK Biologicals Kft (Gödöllö). Engerix™-B (HBV): GSK Biologicals’ Hepatitis B vaccine DTPwCSL (Triple Antigen™): Commonwealth Serum Laboratory’s combined diphtheria (D), tetanus (T) and whole cell pertussis (Pw) vaccine Tritanrix™-HepB (DTPw-HBV): Combined diphtheria, tetanus, whole cell pertussis and hepatitis B vaccine.
104021 (DTPw CSL-HBV GOD-005) III A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals’ Kft’s DTPw-HBV Kft. vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Tritanrix™-HepB (DTPw-HBV): GSK Biologicals’ combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine. Rotarix (HRV): GSK Biologicals’ live attenuated human rotavirus vaccine PLc: placebo for the HRV vaccine Zilbrix (DTPw-HBV Kft): GSK Biologicals Kft’s combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine Triple Antigen™ (DTPwcsl): Commonwealth Serum Laboratory’s (CSL’s) combined diphtheria-tetanus-whole cell B. pertussis vaccine. Engerix™-B (HBV): GSK Biologicals’ hepatitis B vaccine
196131/001 (DTPwCSL-HBVGOD-001) II A phase III, partially double blind, randomized, multicentric study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Kft’s combined DTPwCSL-HB vaccine as compared to Commonwealth Serum Laboratory’s (CSL’s) DTPwCSL (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B) administered concomitantly at separate injection sites and to GSK Biologicals’ DTPw-HB vaccine (Tritanrix™-HepB) when administered to healthy infants at 3, 4 and 5 months of age. DTPwCSL-HB (DTPwCSL-HBV): GSK Biologicals Kft’s combined diphtheria, tetanus, whole cell Bordetella pertussis vaccine with the Pw component produced by Commonwealth Serum Laboratory and the D and T components produced by GSK Biologicals Kft (Gödöllö). Engerix™-B (HBV): GSK Biologicals’ Hepatitis B vaccine DTPwCSL (Triple Antigen™): Commonwealth Serum Laboratory’s combined diphtheria (D), tetanus (T) and whole cell pertussis (Pw) vaccine Tritanrix™-HepB (DTPw-HBV): Combined diphtheria, tetanus, whole cell pertussis and hepatitis B vaccine