Meningococcal serogroups A, C, W-135 and Y 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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meningococcal serogroups A, C, W-135 and Y vaccine studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
102394 IV Phase IV, partially double-blind study to demonstrate the non-inferiority of an investigational vaccination regimen versus GlaxoSmithKline (GSK) Biologicals’ Mencevax ACWY when administered as a single dose to subjects aged 2-30 years. Mencevax ACWY: GSK Biologicals’ meningococcal serogroup MenACWY vaccine.
104730 III A phase III, multicentre booster vaccination study to assess the immunogenicity, safety and reactogenicity of a dose of Mencevax™ ACWY at 24 to 30 months of age in subjects primed with an investigational vaccination regimen in study 100480 and boosted at 15 to 24 months of age in study 104727. Mencevax™ ACWY (MenACWY): GlaxoSmithKline (GSK) Biologicals’ licensed meningococcal serogroups A, C, W, Y polysaccharide vaccine.
104171 & 104730 III 104171: A phase III, multicenter, multicountry, vaccination study to assess the safety and reactogenicity of a an investigational vaccination regimen or a booster dose of DTPw-HBV/Hib when administered at 15 to 18 (upper limit for age extended from 18 months to 24 months only for Thailand) months of age (single-blind) and of a dose of Mencevax™ ACWY vaccine when administered at 24 to 30 months of age (open label) in subjects who were primed in the safety study 759346/004 and safety study 100791. 104730: A phase III, multicentre booster vaccination study to assess the immunogenicity, safety and reactogenicity of an investigational vaccination regimen at 15 to 24 months of age and to assess the immunogenicity, safety and reactogenicity of a dose of Mencevax™ ACWY at 24 to 30 months of age in subjects primed with an investigational vaccination regimen in study 100480. Tritanrix™-HepB (DTPw-HBV): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine. Hiberix™ (Hib): GSK Biologicals’ Haemophilus influenzae type b tetanus conjugate vaccine. Mencevax™ ACWY (MenACWY): GSK Biologicals’ meningococcal serogroups A, C, W135 and Y polysaccharide vaccine.
208144-001 (MenACWY-001) III A phase III, open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Mencevax™ ACW135Y vaccine when administered as a single dose to healthy subjects aged 2-30 years. Mencevax™ ACW135Y: GSK Biologicals’ meningococcal serogroups ACWY vaccine (MenACWY).
103532 II A phase II, randomized, controlled, primary vaccination study to assess the immunogenicity, safety and reactogenicity of investigational vaccination regimens versus one subcutaneous dose of MENCEVAX™ ACWY in healthy adolescents/young adults aged 15-19 years. MENCEVAX™ ACWY (MenACWY): GlaxoSmithKline (GSK) Biologicals’ licensed meningococcal serogroups A, C, W-135, Y vaccine
104702 II A Phase II open (partially double-blind), randomized, controlled, primary vaccination study to assess the immunogenicity, safety and reactogenicity of investigational vaccination regimens versus one subcutaneous dose of MENCEVAX™ ACWY in healthy adolescents/young adults aged 15-19 years. MenACWY (Mencevax™ ACWY): GSK Biologicals’ meningococcal serogroups A, C W-135, Y vaccine.
104703 II A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of investigational vaccination regimens versus MENINGITEC™ or MENCEVAX™ ACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old. MENINGITEC™ (MenC): Wyeth’s meningococcal C conjugate vaccine. MENCEVAX™ ACWY (MenACWY): GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W, Y vaccine.
103533-103534 II A Phase II, partially blind, randomized, controlled, dose-range study to evaluate the immunogenicity, reactogenicity and safety of investigational vaccination regimens versus MenC CRM197 conjugate vaccine or MENCEVAX™ ACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old. MENCEVAX™ ACWY (MenACWY): GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135 and Y vaccine. Meningitec™ (MenC): Wyeth’s MenC CRM197 conjugate vaccine. Note: This study consisted of two stages: the primary vaccination phase (Study Stage 1: 103533) and the booster phase (Study Stage 2: 103534).
108595 - EXT: 104702, MTH 18 II A phase II, open, controlled study to assess the long term persistence of an investigational vaccination regimen versus one subcutaneous dose of Mencevax™ ACWY in healthy adolescents/young adults who were primed in study 104702 and were 15 to 19 years of age at the time of vaccination. Mencevax™ ACWY: GSK Biologicals’ meningococcal serogroups A, C, W-135, Y polysaccharide vaccine (MenACWY).
134612/003, 102252, 102253, 102254 II A phase II open, primary vaccination study to assess the safety, reactogenicity, immunogenicity and long-term persistence of an investigational vaccination regimen versus one subcutaneous dose of Mencevax™ ACWY in healthy adults aged 18-25 years. Mencevax™ ACWY (MenACWY): GlaxoSmithKline Biologicals’ meningococcal serogroups A, C, W-135 & Y vaccine
134612/004 II A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of investigational vaccination regimens versus a licensed MenC vaccine or Mencevax™ ACWY when given in children aged 12 to 14 months and 3 to 5 years old. Mencevax™ ACWY: GSK Biologicals’ licensed meningococcal serogroup ACWY vaccine (MenACWY)
134612/005 II A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of investigational vaccination regimens versus Mencevax ACWY when given in children aged 3 to 5 years old. Mencevax™ ACWY: GlaxoSmithKline (GSK) Biologicals’ licensed meningococcal serogroup ACWY vaccine (MenACWY)
404286/006 II A phase II, open, randomized, controlled study to assess the immune memory induced by an investigational vaccination regimen and the safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen in toddlers primed in study 404286/001.
675187/001 II A Phase II, open, randomized, controlled study to evaluate the reactogenicity and safety of an investigational vaccination regimen in healthy toddlers aged 24-30 months.