Combined diphtheria-tetanus-whole cell pertussis, hepatitis B vaccine and Haemophilus influenzae type 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 and Haemophilus influenzae type b vaccine (KFT) studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
101223 (DTPW-HBV=HIB KFT-002) III Phase III, multi-country, randomised, controlled, partially-blind study to assess the lot-to-lot consistency of the production method of GlaxoSmithKline Biologicals’ DTPw-HBV/ Hib Kft. vaccine and to compare to GlaxoSmithKline Biologicals’ Tritanrix™-HepB/Hiberix™ vaccine, when administered as a primary vaccination course to healthy infants at 2, 4 and 6 months of age and co-administered with oral live attenuated poliomyelitis vaccine. Tritanrix™-HepB/Hiberix™ (DTPw-HBV/Hib): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine. DTPw-HBV/Hib Kft vaccine (DTPw-HBV/ Hib Kft.) is GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine produced at GSK Biologicals Kft., Gödöllö, Hungary. GSK Biologicals’ licensed trivalent Oral Polio Vaccine (OPV) - Polio Sabin™, was co-administered along with the DTPw containing vaccines.
104065 (DTPW-HBV=HIB KFT-003) III A phase III, open, randomised study to assess the immune memory following primary vaccination with GlaxoSmithKline (GSK) Biologicals’ DTPw-HBV/Hib Kft. vaccine by giving Plain PRP polysaccharide vaccine at 10 months of age, and to assess the immunogenicity and reactogenicity of a booster dose of GSK Biologicals’ DTPw-HBV/Hib Kft. vaccine or DTPw-HBV Kft. vaccine given alone or the concomitant administration of DTPw-HBV Kft. and Hiberix™ vaccines, at 15-18 months of age in subjects primed in study DTPw-HBV=Hib Kft-001. DTPw-HBV/Hib Kft.: GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine. Polyribosil-Ribitol-Phosphate (PRP): plain PRP polysaccharide vaccine DTPw-HBV Kft.: GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary. Hiberix™ (Hib): GSK Biologicals’ Haemophilus influenzae type b vaccine.
104489 (DTPW-HBV=HIB KFT-004) III A phase III, partially double-blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals Kft’s DTPwGod-HBV/Hib Kft. vaccine as compared to GSK Biologicals Kft’s DTPwCSL-HBV/Hib Kft. vaccine and to the concomitant administration of CSL’s Triple Antigen™ and GSK Biologicals’ Hiberix™ vaccine, when administered to healthy infants at 2, 4 and 6 months of age, after a birth dose of hepatitis B vaccine. DTPwGod-HBV/Hib Kft.: combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine mixed with Haemophilus influenzae type b vaccine developed and manufactured by GSK Biologicals Kft., Gödöllö, Hungary. DTPwCSL-HBV/Hib Kft.: combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine mixed with Haemophilus influenzae type b vaccine developed and manufactured by GSK Biologicals Kft., Gödöllö, Hungary in co-operation with Commonwealth Serum Laboratory (CSL), Australia. Triple Antigen™: CSL’s combined diphtheria-tetanus-whole cell Bordetella pertussis (DTPwCSL) vaccine. Hiberix™: GSK Biologicals’ Haemophilus influenzae type b vaccine.
106602 (DTPw-HBV=Hib-Kft-006) III A phase III, open, multicentric, clinical study to assess the immunogenicity, reactogenicity and safety of a booster dose of GlaxoSmithKline (GSK) Biologicals combined DTPw-HBV/Hib Kft. vaccine as compared to GSK Biologicals’ Tritanrix™-HepB/Hiberix™ vaccine, when administered to healthy infants between 18 and 24 months of age, who have received a three-dose primary immunization course with the same vaccines as in study DTPw-HBV=Hib Kft-002 (101223). DTPw-HBV/Hib Kft.: GlaxoSmithKline (GSK) Biologicals’ combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine mixed with Haemophilus influenzae type b low-dose vaccine with the D, T and Pw components produced by GSK Biologicals, Gödöllö. Tritanrix™-HepB/Hiberix™ (DTPw-HBV/Hib): GSK Biologicals’ combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine, mixed with Haemophilus influenzae type b conjugate vaccine.
101222 (DTPw-HBV=Hib Kft-001) II Phase III, partially blinded, randomized, controlled, primary vaccination study to demonstrate the non-inferiority of GlaxoSmithKline (GSK) Biologicals’ DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals’ Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants at 6, 10 and 14 weeks of age. The immunogenicity of GSK Biologicals’ DTPw-HBV/Hib Kft. administered after a birth dose of Hepatitis B vaccine will also be assessed. Tritanrix™-HepB/Hiberix™ (DTPw-HBV/Hib): combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine DTPw-HBV/Hib Kft.: GSK Biologicals’ combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine produced at GSK Biologicals Kft., Gödöllö, Hungary. DTPw-HBV Kft.: GSK Biologicals’ combined diphtheria, tetanus, whole cell Bordetella pertussis and hepatitis B vaccine produced at GSK Biologicals Kft., Gödöllö, Hungary. Hiberix™: GSK Biologicals’ Haemophilus Influenzae type b vaccine