Study: NCT00436007

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 17 affected / 170 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 5 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 11 affected / 170 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 6 affected / 170 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 5 affected / 170 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 4 affected / 170 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 2 affected / 170 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 3 affected / 170 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 3 affected / 170 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Salmonella sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Sickle cell anaemia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Blepharitis
Serious: yes
Organ System: Eye disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Hydrocele male infected
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Periorbital abscess
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 6 affected / 170 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 6 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 5 affected / 170 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 7 affected / 170 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 7 affected / 170 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 3 affected / 170 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 2 affected / 170 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 3 affected / 170 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Month 8 and Month 19.
Frequency: 2 affected / 170 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Dysentery
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 82 affected / 170 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 102 affected / 170 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 124 affected / 170 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 68 affected / 170 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Tritanrix™ HepB/Hib
Frequency: 127 affected / 170 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Rouvax™.
Frequency: 52 affected / 163 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with the GSK 257049 vaccine.
Frequency: 126 affected / 170 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Stamaril™.
Frequency: 2 affected / 95 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Tritanrix™ HepB/Hib
Frequency: 47 affected / 170 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Rouvax™.
Frequency: 20 affected / 163 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with the GSK 257049 vaccine
Frequency: 28 affected / 170 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 170 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 170 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 170 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 170 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 170 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 26 affected / 170 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 170 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 170 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 170 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 170 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 170 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 170 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 10 affected / 170 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 10 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 9 affected / 170 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 10 affected / 170 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 4 affected / 170 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 2 affected / 170 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 4 affected / 170 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 2 affected / 170 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Salmonella sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Sickle cell anaemia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Extrapulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 170 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 6 affected / 170 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 6 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 7 affected / 170 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 4 affected / 170 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 6 affected / 170 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 3 affected / 170 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 2 affected / 170 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 2 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 2 affected / 170 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Otitis media chronic
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Pneumonitis chemical
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Urinary tract infection pseudomonal
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 170 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 97 affected / 170 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 95 affected / 170 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 131 affected / 170 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 83 affected / 170 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Tritanrix™ HepB/Hib
Frequency: 133 affected / 170 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Rouvax™.
Frequency: 54 affected / 161 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with the GSK 257049 vaccine.
Frequency: 116 affected / 170 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Stamaril™.
Frequency: 7 affected / 94 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Tritanrix™ HepB/Hib
Frequency: 68 affected / 170 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Rouvax™.
Frequency: 21 affected / 161 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with the GSK 257049 vaccine
Frequency: 44 affected / 170 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 170 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 170 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 170 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 170 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 170 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 28 affected / 170 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 170 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 170 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 170 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 170 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 170 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 170 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 14 affected / 171 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 13 affected / 171 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 8 affected / 171 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 10 affected / 171 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 4 affected / 171 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 3 affected / 171 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 3 affected / 171 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 171 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 171 at risk

Adverse event: Acarodermatitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 2 affected / 171 at risk

Adverse event: Acquired immunodeficiency syndrome
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 171 at risk

Adverse event: Acute leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 171 at risk

Adverse event: Cataract congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 171 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 171 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 171 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 0 and Month 8.
Frequency: 1 affected / 171 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 14 affected / 171 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 10 affected / 171 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 7 affected / 171 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 5 affected / 171 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 2 affected / 171 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 3 affected / 171 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 2 affected / 171 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 2 affected / 171 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Acquired immunodeficiency syndrome
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Glomerulonephritis
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Petroleum distillate poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: SAE reported between Month 8 and Month 19.
Frequency: 1 affected / 171 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 72 affected / 171 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 75 affected / 171 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 118 affected / 171 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 70 affected / 171 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Tritanrix™ HepB/Hib
Frequency: 140 affected / 171 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Rouvax™.
Frequency: 47 affected / 159 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Stamaril™.
Frequency: 2 affected / 94 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Tritanrix™ HepB/Hib
Frequency: 68 affected / 171 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported after vaccination with Rouvax™.
Frequency: 16 affected / 159 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 65 affected / 171 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 171 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 171 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 171 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 171 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 29 affected / 171 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 171 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 171 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 171 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 171 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 171 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 171 at risk