Study: NCT00323622

Adverse event: Ascariasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Haemophilus sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Hepatitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 176 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 176 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 176 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 176 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group, and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 12 affected / 176 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: Occurrences of this SAE were fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 2 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 20 affected / 176 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 2 affected / 176 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 515 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Tinea capitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group, and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 8 affected / 515 at risk

Adverse event: HIV infection
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A ≥24M Group.
Frequency: 1 affected / 515 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: Occurrences of this SAE were fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 2 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 14 affected / 515 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 2 affected / 515 at risk

Adverse event: Marasmus
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A ≥24M Group.
Frequency: 1 affected / 515 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group, and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 1 affected / 42 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: Occurrences of this SAE were fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 2 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 1 affected / 42 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 159 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 159 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 159 at risk

Adverse event: Cerebral malaria
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 159 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 159 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 2 affected / 159 at risk

Adverse event: Immunosuppression
Serious: yes
Organ System: Immune system disorders
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 159 at risk

Adverse event: Kwashiorkor
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 159 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 159 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 159 at risk

Adverse event: Salmonella sepsis
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 159 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group and one subject in the Cohort 2-Engerix-B ≥24M Group
Frequency: 1 affected / 159 at risk

Adverse event: Acquired immunodeficiency syndrome
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for 2 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 2 affected / 159 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group, and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 14 affected / 159 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: Occurrences of this SAE were fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 2 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 18 affected / 159 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 3 affected / 159 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 528 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 528 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 2 affected / 528 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 528 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 528 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 528 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 528 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 528 at risk

Adverse event: Fungal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 528 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 2 affected / 528 at risk

Adverse event: Herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 528 at risk

Adverse event: Pyoderma
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 528 at risk

Adverse event: Salmonella sepsis
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 1 affected / 528 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 528 at risk

Adverse event: Subcutaneous haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 528 at risk

Adverse event: Underweight
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 528 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group, and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 9 affected / 528 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: Occurrences of this SAE were fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 2 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 19 affected / 528 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group.
Frequency: 3 affected / 528 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: Occurrences of this SAE were fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 2 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 1 affected / 43 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 140 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 140 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 140 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix \<24M Group and one subject in the Cohort 2-Engerix-B ≥24M Group
Frequency: 1 affected / 140 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group, and 3 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 1 affected / 140 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: Occurrences of this SAE were fatal for one subject in the Cohort 1-RTS,S/AS02A \<24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 2 subjects in the Cohort 1-Prevnar-Hiberix \<24M Group
Frequency: 2 affected / 140 at risk