COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & AOM Efficacy Study of the Pneumococcal Conjugate Vaccine

• Occurrence of likely bacterial Community Acquired Pneumonia (CAP) cases [ Time Frame: As of 2 weeks after completion of 3-dose primary vaccination till the study end in all evaluable subjects ] [ Designated as safety issue: No ]
  

• In a subset, occurrence of clinically confirmed Acute Otitis Media (AOM) cases [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• Occurrence of CAP cases with alveolar consolidation or pleural effusion on the Chest X-ray (CRX) [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• In a subset, occurrence of bacteriologically confirmed AOM cases (B-AOM) caused by any bacterial pathogen [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ 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 [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• In a subset, occurrence of bacteriologically confirmed AOM cases (B-AOM) caused by H. influenzae [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• In a subset, occurrence of bacteriologically confirmed AOM cases (B-AOM) caused by non-typeable H. influenzae [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• In a subset, occurrence of bacteriologically confirmed AOM cases (B-AOM) caused by other AOM pathogens (for example Moraxella catarrhalis, Group A streptococci and Staphylococcus aureus [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• Occurrence of CAP cases with alveolar consolidation or pleural effusion on the Chest X-ray (C-CAP) with positive respiratory viral test [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• Occurrence of CAP cases with any abnormal CXR with positive respiratory viral test [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• Occurrence of likely bacterial CAP (B-CAP) cases with positive respiratory viral test [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• Occurrence of suspected CAP cases [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• Occurrence of CAP cases with any abnormal CXR [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ 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 (month 0 to month 22-25) ] [ 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 (month 0 to month 22-25) ] [ 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 (month 0 to month 22-25) ] [ 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 (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• Occurrence of IPD cases due to cross-reactive pneumococcal serotypes and other pneumococcal serotypes [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• Occurrence of invasive disease cases due to H. influenzae [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ 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 (month 0 to month 22-25) ] [ 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 (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• In a subset, occurrence of antibiotic prescriptions [ Time Frame: Throughout the study (month 0 to month 22-25) ] [ Designated as safety issue: No ]
  
• Occurrence of serious adverse events [ Time Frame: From the administration of the first vaccine dose (month 0) up to study end (month 22-25) ] [ 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 pneumococcal serotypes [ Time Frame: One month after the third dose (month5), just before the booster dose (month 13), one month post-booster dose (month 14) of GSK Biologicals' 1024850A and at last scheduled visit (month 22-25) ] [ Designated as safety issue: No ]
  
• In a subset, Opsonophagocytic activity against pneumococcal serotypes [ Time Frame: One month after the third dose (month 5), just before the booster dose (month 13), one month post-booster dose (month 14) of GSK Biologicals' 1024850A and at last scheduled visit (month 22-25) ] [ Designated as safety issue: No ]
  
• In a subset, antibody concentrations against protein D [ Time Frame: One month after the third dose (month 5), just before the booster dose (month 13), one month post-booster dose (month 14) of GSK Biologicals' 1024850A and at last scheduled visit (month 22-25) ] [ Designated as safety issue: No ]
  

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.

The protocol posting has been updated according to the amendment of the protocol dated 14 December 2009.

The protocol posting has been updated according to the amendment of the protocol dated 09 September 2010.