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  • Safety and immunogenicity study of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccine 2830930A when given as 1 dose to healthy toddlers aged 12-23 months.
  • 1-dose vaccination of healthy toddlers between 12-23 months of age at the time of vaccination against Streptococcus pneumoniae (S. pn) and Haemophilus influenzae (Hi) who previously received 3 doses of Synflorix. MedDRA version: 14.0 Level: LLT Classification code 10018953 Term: Haemophilus influenzae meningitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10042194 Term: Streptococcus pneumoniae meningitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10042196 Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10018954 Term: Haemophilus influenzae secondary bacterial infection of acute bronchitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10018952 Term: Haemophilus influenzae infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10035680 Term: Pneumonia due to Haemophilus influenzae (H. influenzae) System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10054642 Term: Streptococcus pneumoniae septicemia System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10042195 Term: Streptococcus pneumoniae pneumonia System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10058214 Term: Septicaemia due to haemophilus influenzae (H. influenzae) System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10042197 Term: Streptococcus pneumoniae septicaemia System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
  • Germany
  • 2011-08-22