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Result Summaries: Combined Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine

GSK
Study ID
   Phase    Title Summary (Download)
101853 Phase 2 A randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ investigational vaccination regimen, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age. (0 citation(s)) Click here to download result summary.
104005 Phase 3 Phase IIIb, open, randomized, multicenter study to assess the immunogenicity & safety of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in Indian infants when given at 6-10-14 weeks of age or at 2-4-6 months of age (0 citation(s)) Click here to download result summary.
106786 Phase 2 A study to evaluate the immunogenicity and safety of a new formulation of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine as compared to the currently licensed Infanrix hexa in healthy infants (2,3,4 M) (0 citation(s)) Click here to download result summary.
217744/063 Phase 3 Open, clinical study to assess the safety and reactogenicity of GSK Bios’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vac. admin. with GSK Bios’ Haemophilus influenzae type b, tetanus conjugate vac. in healthy infants, before a dose of the same vac and OPV (0 citation(s)) Click here to download result summary.
217744/070 Phase 3 An open clinical study to assess the immunogenicity and safety of GSK Bio’s DTPa-HBV-IPV vaccine mixed in one syringe with Hib vaccine, as a primary vaccination course to pre-term infants(<37 weeks) at 2, 4 and 6 months of age in comparison with infants born after normal gestation period (4 citation(s)) Click here to download result summary.
217744/076 Phase 4 An open, multicenter, phase IV clinical trial to assess the immunogenicity and reactogenicity of three doses of GSK Bios’ combined DTPa-HBV-IPV/Hib vaccine in healthy infants at 2, 4 and 6 months of age, when co-administered with Wyeth-Lederle’s meningococcal group C conjugate vaccine. (3 citation(s)) Click here to download result summary.
217744/078 Phase 4 An open, multicentre, phase IV clinical trial to assess the immunogenicity and reactogenicity of GSK Bios’ combined DTPa-HBV-IPV/Hib vaccine, when co-administered at 3-4-5 Mth of age with Wyeth-Lederle's seven-valent pneumococcal conjugate vaccine at a different injection site during the same visit (1 citation(s)) Click here to download result summary.
217744/081 Phase 4 An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of a 4th dose of GSK Bios’ combined DTPa-HBV-IPV/Hib vac., co-admin with Wyeth's seven-valent Pneumococcal conjugate vac. at a different injection site during the same visit in healthy children (4 citation(s)) Click here to download result summary.
217744/083 Phase 4 Study to assess immunogenicity and reactogenicity of GSK Bio’s combined DTPa-HBV-IPV/Hib vaccine in pre-term infants in comparison with term infants, administered as a booster dose to children who previously were primed with 3 doses of GSK Biologicals combined DTPa-HBV-IPV/Hib vaccine (2 citation(s)) Click here to download result summary.
217744/086 Phase 4 Single-blind, multicentre, phase IV clinical trial to assess and compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) and Aventis Pasteur’s DTPa-HBV-IPV-Hib vaccine (Hexavac™) given as a primary vaccination course at 2, 4 and 6 months of age. (3 citation(s)) Click here to download result summary.
217744/090 Phase 4 A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa() given as a primary vaccination course at 2, 4 and 6 months of age to pre-term infants. (1 citation(s)) Click here to download result summary.
217744/093 Phase 3 Phase IIIb, multicenter, open label, non controlled, study to assess immunogenicity and reactogenicity of GSK Infanrix hexa® (DTPa-HBV-IPV/Hib) and Infanrix Quinta® (DTPa-IPV/Hib) vaccines co-administered with Wyeth Prevenar® vaccine at different injection sites in healthy children (1 citation(s)) Click here to download result summary.
217744/095 Phase 4 Study to assess immunogenicity and reactogenicity of GSK Bio’s DTPa-HBV-IPV/Hib vaccine when given as a booster dose to children previously primed at 2-4-6 months of age either with Aventis Pasteurs DTPa-HBV-IPV-Hib vaccine or GSK Bio’s DTPa-HBV-IPV/Hib vaccine in study DTPa-HBV-IPV-086 (3 citation(s)) Click here to download result summary.
347414/020 Phase 3 A Phase III, randomized, single blind study to assess the immune response induced by Prevenar™(Wyeth Lederle) when admin to healthy infants with DTPa-HBV-IPV/Hib, compared to an investigational vaccination regimen as a 3-dose primary vaccination course at a monthly interval starting at 8–16W of age (0 citation(s)) Click here to download result summary.
347414/026 Phase 3 A Phase III, randomized single-blind clinical trial to assess the immune memory induced by an investigational vaccination regimen in comparison with Prevnar and the immune response to a 4th dose of the pneumococcal vaccine and the investigational vac regimen, when admin to healthy children(12-15M) (0 citation(s)) Click here to download result summary.
347414/035 Phase 3 A phase-III, open, controlled, follow-up clinical trial, with Prevenar as control, to assess the safety of GSK Bios’ investigational vac regimen admin with DTPa-HBV-IPV/Hib to healthy children, previously vac in infancy with the investigational vac regimen in a primary study in the Netherlands (0 citation(s)) Click here to download result summary.
444563/020 Phase 2 Phase II, double-blind randomised, placebo controlled clinical dose-range study to assess immunogenicity and reactogenicity of an investigational vaccination regimen, and to assess immunogenicity of OPV orally co-admind to healthy infants at 2, 4 and 6 months of age (0 citation(s)) Click here to download result summary.
759348/001 Phase 2 A randomised, controlled phase II study to evaluate the safety and immunogenicity of 7 different formulations of GSK Bios’ investigational vaccination regimen, when administered as a 3-dose primary immunisation schedule before 6 months of age, followed by a 4th dose during the 2nd year of life (0 citation(s)) Click here to download result summary.
759348/002 Phase 2 A randomized, controlled, phase II study to evaluate the safety and immunogenicity of 7 different formulations of an investigational vaccination regimen, when administered as a 3-dose primary immunization schedule before 6 months of age, followed by a 4th dose during the second year of life. (0 citation(s)) Click here to download result summary.
759348/003 Phase 2 A randomized, controlled, phase II study to evaluate the safety and immunogenicity of four different formulations of GlaxoSmithKline (GSK) Biologicals’ investigational vaccination regimen, when administered as a 3-dose primary immunization schedule beginning before 6 months of age. (0 citation(s)) Click here to download result summary.
759348/007 Phase 2 A randomized, controlled, phase II study to evaluate the safety and immunogenicity of five formulations of GlaxoSmithKline Biologicals’ investigational vaccination regimen, when administered intramuscularly as a 3-dose primary immunization schedule (2-3-4 month schedule) before 6 months of age. (0 citation(s)) Click here to download result summary.