A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Meningitec™ or Mencevax™ ACWY to healthy subjects aged 1 through 10 years of age - MenACWY-TT-027-028-029-030-031-032

INTERVENTION: Product Name: MenACWY conjugate vaccine Product Code: MenACWY‐TT Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: N.meningitidis serogroup A polysaccharide (PSA) conjugated to tetanus toxoid (TT) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: PSA:5 TT:15‐ INN or Proposed INN: N.meningitidis serogroup C polysaccharide (PSC) conjugated to tetanus toxoid (TT) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: PSC:5 ‐ TT:15‐ INN or Proposed INN: N.meningitidis serogroup W polysaccharide (PSW) conjugated to tetanus toxoid (TT) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: PSW:5 ‐ TT:7.5‐ INN or Proposed INN: N.meningitidis serogroup Y polysaccharide (PSY) conjugated to tetanus toxoid (TT) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: PSY:5 ‐ TT:6.5‐ Trade Name: Mencevax ACWY Product Name: Mencevax ACWY Product Code: MenACWY Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: N.meningitidis serogroup A polysaccharide (PSA) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed INN: N.meningitidis serogroup C polysaccharide (PSC) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed INN: N.meningitidis serogroup W polysaccharide (PSW) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed INN: N.meningitidis serogroup Y polysaccharide (PSY) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ Trade Name: Meningitec Product Name: Meningitec Product Code: Meningococcal group C oligosaccharide conjugate Pharmaceutical Form: Suspension for injection INN or Proposed INN: N.meningitidis serogroup C polysaccharide (PSC) conjugated to Corynebacterium diphtheriae protein (CRM‐1 CONDITION: Primary immunization of healthy subjects aged 1 through 10 years against meningococcal disease due to serogroup A, C, W‐135 or Y. PRIMARY OUTCOME: Main Objective: One month after vaccination:; For Subjects of two years of age and above; • To evaluate the non‐inferiority of the MenACWY‐TT conjugate vaccine compared to the licensed Mencevax ACWY in terms of the vaccine response to MenA, MenC, MenY and MenW‐135* ; *Response to a vaccine antigen component is defined as : ; ‐ for initially seronegative subject, post vaccination rSBA titer = 1:32; ‐ for initially seropositive subject, at least 4‐fold increase in rSBA titre from pre to post vaccination; For Subjects below two years of age; • To evaluate the non‐inferiority of the vaccine response induced by the MenACWY‐TT conjugate vaccine when compared to the licensed Meningitec vaccine for N. meningitidis serogroup C as measured by serum bactericidal antibodies (rSBA).; • To evaluate the immunogenicity induced by the MenACWY‐TT conjugate vaccine when compared to the licensed Meningitec vaccine for N. meningitidis serogroups A, W‐135, and Y as measured by rSBA. ; Primary end point(s): For Subjects of two years and above, one month post vaccination: ; • Vaccine response to MenA, MenC, MenY and MenW‐135 defined as:; ‐ for initially seronegative subject, post vaccination rSBA titer = 1:32; ‐ for initially seropositive subject, at least 4‐fold increase in rSBA titre from pre to post vaccination; For Subjects below two years of age, prior to and one month after vaccination; • group MenACWY‐TT: rSBA‐MenA, rSBA‐MenC, rSBA‐MenW and rSBA‐MenY titres =1:8 ; • group control Meningitec: rSBA‐MenC titres =1:8; Secondary Objective: 1m post vacc: 1) to compare the immunogenicity of MenACWY‐TT with that of Mencevax ACWY (subjects= 2y)/Meningitec (subjects < 2y). 2) To evaluate the reactogenicity of MenACWY‐TT when compared to Mencevax ACWY (subjects= 2y)/Meningitec (subjects < 2y). To assess the safety profile of MenACWY‐TT when compared to Mencevax ACWY (subjects= 2y)/Meningitec (subjects < 2y) in terms of any grade 3 systemic symptom 0‐3d post vacc. To describe SAEs, specific AEs, and conditions prompting emergency room/ physician office visits that are not related to well‐being care, vaccination, injury, or common acute illnesses and any event related to lack of vaccine efficacy up to 6 m after vaccination.; 1‐5 y post vaccination: to compare the persistence of the immunogenicity of MenACWY‐TT with that of Mencevax ACWY (subjects= 2y)/Meningitec (subjects < 2y). To describe SAEs related to vaccination and any event related to lack of vaccine efficacy from 6 m up to 5y post vacc in a retrospective manner.; INCLUSION CRITERIA: All subjects must satisfy the following criteria at study entry: • Subjects who the investigator believes that their parent or legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow‐up visits) should be enrolled in the study. • A male or female between, and including, 1 through 10 years of age at the time of vaccination. • Written informed consent obtained from the parent or legally acceptable representative of the subject. • Free of obvious health problems as established by medical history and clinical examination before entering into the study. • Previously completed routine childhood vaccinations to the best of his/her parents/legally acceptable representative’s knowledge (however, previous meningococcal vaccination is an exclusion criterion) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 y