Study: NCT00460525

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 201 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 201 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 55 affected / 201 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 201 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 201 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 201 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 50 affected / 201 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 126 affected / 201 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 201 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 201 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 201 at risk

Adverse event: Mumps
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 201 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 201 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 201 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 201 at risk

Adverse event: Pyoderma
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 201 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 127 affected / 201 at risk

Adverse event: Salmonellosis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 201 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 201 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 201 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 201 at risk

Adverse event: Trichomoniasis intestinal
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 201 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 201 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 39 affected / 201 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 201 at risk

Adverse event: Granulocyte count increased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 201 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 94 affected / 201 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 201 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 201 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 47 affected / 201 at risk

Adverse event: Red blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 201 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 201 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 201 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 201 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 109 affected / 201 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 201 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 201 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 201 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 92 affected / 201 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 129 affected / 201 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 201 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 46 affected / 201 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 201 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 199 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 199 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 199 at risk

Adverse event: Cerebral malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 199 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 199 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 199 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 49 affected / 199 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 199 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 199 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 199 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 89 affected / 199 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 121 affected / 199 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 199 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 199 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 199 at risk

Adverse event: Mumps
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 199 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 199 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 199 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 199 at risk

Adverse event: Pyoderma
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 199 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 123 affected / 199 at risk

Adverse event: Salmonellosis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 199 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 199 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 199 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 199 at risk

Adverse event: Trichomoniasis intestinal
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 199 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 199 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 41 affected / 199 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 199 at risk

Adverse event: Granulocyte count increased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 199 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 92 affected / 199 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 199 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 199 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 59 affected / 199 at risk

Adverse event: Red blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 199 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 199 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 199 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 199 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 199 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 104 affected / 199 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 199 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 199 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 199 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 13 affected / 199 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 180 affected / 199 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 192 affected / 199 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 17 affected / 199 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 104 affected / 199 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 199 at risk