A phase III randomized, single-blind, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine with Pediacel™ versus co-administration with Infanrix hexa™, when administered to infants as a three-dose primary vaccination course during the first six months of life and as a booster dose at 11-13 months of age. - 10PN-PD-DIT-027 PRI, 10PN-PD-DIT-027 BST

INTERVENTION: Product Name: Synflorix Product Code: 10Pn‐PD‐DiT Pharmaceutical Form: Suspension for injection INN or Proposed INN: PS‐PD for serotypes 1‐4‐5‐6B‐7F‐9V‐14‐23F, PS‐TT for 18C, PS‐DT for 19F Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: PS:32/PD:24‐TT:14/DT:9 Trade Name: Infanrix hexa Product Name: Infanrix hexa Product Code: DTPa‐HBV‐IPV/Hib Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Diphtheria toxoid Concentration unit: IU international unit(s) Concentration type: not less then Concentration number: 30‐ INN or Proposed INN: Tetanus Toxoid Concentration unit: IU international unit(s) Concentration type: not less then Concentration number: 40‐ INN or Proposed INN: bordetella pertussis antigens:Pertussis toxid (PT), filamentous haemagglutinin(FHA), pertactin(PRN) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: PT:25; FHA:25‐PRN:8 INN or Proposed INN: Hepatitis B surface antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 10‐ INN or Proposed INN: Poliovirus, inactivated, 3 types:1‐2‐3 Concentration unit: DAgU D antigen unit(s) Concentration type: equal Concentration number: 1:40; 2:8; 3:32‐ INN or Proposed INN: Haemophilus type B polysaccharide conjugated to tetanus toxoid as carrier protein Concentration unit: µg microgram(s) Concentration type: equal Concentration number: Hib:10‐TT:20‐40 Trade Name: Prevenar Product Name: Prevenar Pharmaceutical Form: Suspension for injection Trade Name: Pediacel Product Name: Pediacel Pharmaceutical Form: Suspension for injection CONDITION: Three‐dose primary vaccination of healthy infants between 6‐12 weeks (42‐90 days) of age at the time of the first vaccination against Streptococcus pneumoniae and booster vaccination at 11‐13 months of age. PRIMARY OUTCOME: Main Objective: •To demonstrate that GSK Biologicals’ 10 valent pneumococcal conjugate vaccine when co‐administered with DTPa‐IPV‐Hib (Pediacel) (10Pn‐PDC group) is non‐inferior to co‐administration with DTPa‐HBV‐IPV/Hib (Infanrix hexa) (10Pn‐Hexa group), in terms of immune response to the 10 pneumococcal vaccine serotypes and to protein D, when administered as a three‐dose primary vaccination course.; Criteria for non‐inferiority:; For each of the 10 pneumococcal vaccine serotypes and protein D, non‐inferiority will be demonstrated if the upper limit of the 2‐sided 95% CI of the GMC ratio between groups (10Pn‐Hexa group over 10Pn‐PDC group), is lower than 2.; Primary end point(s): One month after the administration of the 3rd dose of pneumococcal conjugate vaccine: ; •Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. ; •Antibody concentration against protein D.; Secondary Objective: Non‐inferiority of Pediacel co‐administered with 10Pn‐PD‐DiT to co‐administration with Prevenar administered as 3‐dose primary vaccination if for each of the DTPa‐IPV‐Hib antigens the upper limit of the 2‐sided 95% CI of the GMC or GMT ratio’s respectively between groups is <2; Impact of 10Pn‐PD‐DiT on nasopharyngeal carriage of H. influenzae.; Safety/reactogenicity of 10Pn‐PD‐DiT co‐administered with Infanrix hexa or Pediacel as 3‐dose primary vaccination during first 6 months of life; Antibody persistence pre‐booster, 6‐8 months after completion of primary vaccination with 10Pn‐PD‐DiT co‐administered with Infanrix hexa or Pediacel.; One month post‐booster, immunogenicity of 10Pn‐PD‐DiT co‐administered with Infanrix hexa or Pediacel at 11‐13 months of age; Safety/reactogenicity of booster dose of 10Pn‐PD‐DiT co‐administered with Infanrix hexa or Pediacel at 11‐13 months of age; Antibody persistence 12 months after 4th‐dose of 10Pn‐PD‐DiT co‐administered with Infanrix hexa or Pediacel INCLUSION CRITERIA: Subjects who the investigator believes that their parents/guardian(s) 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, 6‐12 weeks (42‐90 days) of age at the time of the first vaccination. Written informed consent obtained from both parents or from the guardian(s) of the subject. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Born after a gestation period of at least 36 weeks. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range