Haemophilus influenzae type b-meningococcal C-TT conjugate vaccine studies
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| Study ID | Phase | Title |
| 811936/003 (Hib-MenC-TT-003) | III | A phase III, open, randomized, controlled, multicentre study to evaluate the safety and reactogenicity profile of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b (Hib) – meningococcal serogroup C (MenC) conjugate (Hib-MenC) candidate vaccine given concomitantly with GSK Biologicals’ diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) vaccine and to compare it with MenC-CRM197 conjugate vaccine co-administered with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine, when given as a 3-dose primary vaccination (at 2, 3, 4 months of age) to healthy infants. |
| 102547 (Hib-MenC-TT-010) | III | A Phase III open, multicentre, booster vaccination study to assess the immunogenicity, safety and reactogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine (Hib-MenC) compared to a booster dose of Infanrix hexa (combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Hib vaccine) when given to 14-month-old subjects who were primed in study 217744/097 (DTPa-HBV-IPV-097). |
| 103954 (Hib-MenC-TT-011) | III | A phase III, open (partially double-blind), randomized, controlled, multicenter study to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b - meningococcal serogroup C (Hib-MenC) conjugate vaccine given concomitantly with GSK Biologicals' measles, mumps and rubella (MMR) vaccine (Priorix™) versus Hib-MenC only and MMR only, in toddlers aged 13–14 months who have been primed in infancy with three doses of Hib (given as part of a combined DTPa –containing vaccine) and meningococcal serogroup C CRM197 (MenC-CRM197) conjugate vaccines. Hib-MenC (Menitorix): GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b meningococcal serogroup C tetanus toxoid conjugate vaccine. Priorix™ (MMR): GSK Biologicals' combined measles, mumps and rubella vaccine. DTPa: licensed diphtheria, tetanus, acellular pertussis vaccine. Hib: Haemophilus influenzae type b vaccine. |
| 103974 (Hib-MenC-TT-012) | III | A phase III open (partially double-blind), controlled, multicentre, multicountry primary and booster vaccination study to demonstrate the non-inferiority of the meningococcal serogroup C immune response of GlaxoSmithKline (GSK) Biologicals’ Hib-MenC vaccine co-administered with Infanrix-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel when given according to a 2, 3, 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age. Hib-MenC (Menitorix): GSK Biologicals’ combined Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) tetanus toxoid conjugate vaccine. Infanrix-IPV: GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, inactivated polio virus (DTPa-IPV) vaccine. Pediacel: Sanofi Pasteur’s combined DTPa-IPV-Hib vaccine. |
| 104056 (Hib-MenC-TT-013 BST:012) | III | A phase III open (partially double-blind), controlled, multicenter, multicountry primary and booster vaccination study to demonstrate the non-inferiority of the meningococcal serogroup C immune response of GlaxoSmithKline (GSK) Biologicals’ Hib-MenC vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age. Hib-MenC (Menitorix): GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b (Hib) – meningococcal serogroup C (MenC) tetanus toxoid conjugate vaccine. Infanrix™-IPV (DTPa-IPV): GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, inactivated polio vaccine. Meningitec™ (Lic-MenC): Wyeth’s licensed meningococcal serogroup C conjugate vaccine. Pediacel™ (DTPa-IPV/Hib): Sanofi Pasteur’s combined diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b vaccine. |
| 106672 (Hib-MenC-TT-022 EXT 010 M18) & 106673 (Hib-MenC-TT-023 EXT 010 M30) | III | A Phase III, open, multicenter study to assess the long-term persistence of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine (Hib-MenC) compared to a booster dose of Infanrix™ hexa (combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Hib vaccine) when given to 14-month-old subjects who were primed in study 217744/097 (DTPa-HBV-IPV-097) and boosted in study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097. Hib-MenC (Menitorix™): GSK Biologicals’ combined Haemophilus influenzae type b (Hib) and meningococcal serogroup C tetanus toxoid conjugate vaccine DTPa-HBV-IPV/Hib (Infanrix™ hexa): GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio vaccine and Haemophilus influenzae type b vaccine |
| 811936/001 (Hib-MenC-TT-001) | II | A phase II, open, randomized, controlled study to demonstrate the non-inferiority of the meningococcal serogroup C immune response and the superiority of the Hib immune response of GlaxoSmithKline Biologicals’ (GSK Biologicals) Haemophilus influenzae type b-meningococcal C-TT conjugate vaccine administered concomitantly with Infanrix™ penta versus Meningitec™ administered concomitantly with Infanrix™ hexa as a three-dose primary vaccination to healthy infants at 2, 3 and 4 months of age. Infanrix™ hexa: GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio, Haemophilus influenzae type b (Hib) vaccine (DTPa-HBV-IPV/Hib). Infanrix™ penta: Combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio vaccine (DTPa-HBV-IPV). Meningitec™: Wyeth’s meningococcal serogroup C diphtheria toxoid CRM197 conjugate vaccine (MenC-CRM197). |
| 711202/008 | II | A phase II, open, controlled study to evaluate the persistence and the immune memory induced by a primary vaccination course with investigational vaccination regimens, GSK Biologicals’ Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine or Meningitec™ in healthy toddlers aged 12-15 months primed in study 711202/001. Hib-MenC-TT (Menitorix): GlaxoSmithKline (GSK) Biologicals’ combined Haemophilus influenzae type b polysaccharide-Neisseria meningitidis polysaccharide C conjugated vaccine using tetanus toxoid as carrier protein. Meningitec™: Wyeth’s N. meningitidis serogroup C capsular polysaccharide conjugated to Corynebacterium diphtheria CRM197 protein (MenC-CRM) |