Haemophilus influenzae type b-meningococcal C-TT conjugate vaccine 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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Haemophilus influenzae type b-meningococcal C-TT conjugate vaccine studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
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)