• Occurrence of likely bacterial Community Acquired Pneumonia (CAP) cases [ Designated as safety issue: No ]
• In a subset, occurrence of clinically confirmed Acute Otitis Media (AOM) cases [ Designated as safety issue: No ]

• Occurrence of community acquired pneumonia cases
• Occurrence of clinically confirmed otitis media cases

• Occurrence of CAP cases with alveolar consolidation or pleural effusion on the Chest X-ray (CRX) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• In a subset, occurrence of bacteriologically confirmed AOM cases (B-AOM) caused by vaccine serotypes, cross-reactive & other pneumococcal serotypes or by H. influenzae [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of confirmed CAP cases associated with respiratory viral infection [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of suspected CAP cases [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of CAP cases with any abnormal CXR [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of suspected CAP cases with CRP >=40 mg/L, >=80 mg/L or >=120 mg/L regardless of CXR reading [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of CAP cases with either alveolar consolidation/pleural effusion on the chest X-ray or with non-alveolar infiltrates but with CRP >=80 mg/L or >=120 mg/L [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of bacteriologically culture confirmed Invasive Pneumococcal Disease (IPD) cases caused by any of the pneumococcal vaccine serotypes (VT-IPD) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of VT-IPD cases identified through positive culture or through nonculture pneumococcal diagnostic tests with additional nonculture VT serotyping [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of IPD cases due to cross-reactive pneumococcal serotypes and other pneumococcal serotypes [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of invasive disease cases due to H. influenzae [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• In a subset, occurrence of vaccine serotypes, cross-reactive or other S. pneumoniae serotypes and H. influenzae in the nasopharynx [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• In a subset, acquisition of new S. pneumoniae and/or H. influenzae strains in the nasopharynx [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• In a subset, occurrence of antibiotic prescriptions [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events [ Time Frame: From the administration of the first vaccine dose up to study end ] [ Designated as safety issue: No ]
• In a subset, occurrence of any unsolicited adverse event [ Time Frame: From the administration of the first vaccine dose at 2 months of age up to 24-27 months of age ] [ Designated as safety issue: No ]
• In a subset, occurrence of solicited local symptoms [ Time Frame: Within 4 days after each study vaccine administration ] [ Designated as safety issue: No ]
• In a subset, occurrence of solicited general symptoms [ Time Frame: Within 4 days after each study vaccine administration ] [ Designated as safety issue: No ]
• In a subset, antibody concentrations against protein D [ Time Frame: One month after the third dose, just before the booster dose, one month post-booster dose of GSK Biologicals' 1024850A and at last scheduled visit ] [ Designated as safety issue: No ]
• In a subset, antibody concentrations against pneumococcal serotypes [ Time Frame: One month after the third dose, just before the booster dose, one month post-booster dose of GSK Biologicals' 1024850A and at last scheduled visit ] [ Designated as safety issue: No ]
• In a subset, Opsonophagocytic activity against pneumococcal serotypes [ Time Frame: One month after the third dose, just before the booster dose, one month post-booster dose of GSK Biologicals' 1024850A and at last scheduled visit ] [ Designated as safety issue: No ]

• Occurrence of other pneumonia & otitis media cases
• Safety of vaccine

This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GSK Biologicals' pneumococcal conjugate candidate vaccine to prevent cases of pneumonia (lung infection) likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of otitis media (ear infection) in children under 3 years old.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

The following vaccines will be offered by the sponsor:

• Two doses of hepatitis A vaccine will be offered to all subjects to comply with national recommendations.
• NeisVac-C vaccine against Neisseria meningitis group C will be offered to all subjects in Argentina at 12 months of age.
• Varicella vaccine will be offered to all subjects in Colombia and Panama at 12 months of age.
• Two doses of Rotarix vaccine will be offered to all subjects in Colombia within the first six months of life.

In addition, all subjects will receive a dose of Hepatitis B vaccine at birth according to national recommendations and a dose of MMR vaccine at 12 to 15 months of age according to local EPI. These vaccines will not be provided by the sponsor.

The protocol posting has been updated according to the amendment of the protocol dated 25 Nov 2008.

• Biological: GSK Biologicals' DTPa-IPV/Hib vaccine
  Intramuscular injection, 1 dose in group A and 4 doses in group B
• Biological: Havrix
  Intramuscular injection, 2 doses in group A and 3 doses in group B
  Other Name: Hepatitis A vaccine
• Biological: Pneumococcal conjugate vaccine GSK1024850A
  Intramuscular injection, 4 doses
• Biological: Engerix-B
  Intramuscular injection, 3 doses
  Other Name: Hepatitis B vaccine
• Biological: Infanrix hexa
  Intramuscular injection,3 doses
  Other Name: DTPa-HBV-IPV/Hib

• Group B: Active Comparator
  Interventions:

  • Biological: GSK Biologicals' DTPa-IPV/Hib vaccine
  • Biological: Havrix
  • Biological: Engerix-B
• Group A: Experimental
  Interventions:

  • Biological: GSK Biologicals' DTPa-IPV/Hib vaccine
  • Biological: Havrix
  • Biological: Pneumococcal conjugate vaccine GSK1024850A
  • Biological: Infanrix hexa

Inclusion Criteria:

• A male or female between, and including, 6 and 16 weeks of age at the time of the first vaccination. Pre-term born infants can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age
• Subjects should be living in the area covered by the surveillance system for CAP, invasive disease and AOM
• Written informed consent obtained from the parent or guardian of the subject.
• Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

Exclusion Criteria:

• Use of any investigational or non-registered drug or planned use during the study period.
• Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s).
• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or S. pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine .Other locally recommended vaccines are always allowed, even if concomitantly administered with the study vaccines.
• Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar is not allowed. If Prevnar immunization needs to be initiated, due to the presence of a high risk disease for pneumococcal infections for which the Prevnar vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific Prevnar immunization program.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment
• For Colombia: infants with low birth weight (<2.500g)