Study: NCT00678301

Adverse event: Pneumonia
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 239 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 239 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Allergic bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 83 affected / 239 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 35 affected / 239 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 234 affected / 239 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 57 affected / 239 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 173 affected / 239 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 24 affected / 239 at risk

Adverse event: Fever (rectal temperature ≥ 38.5°C)
Serious: no
Organ System: General disorders
Frequency: 207 affected / 239 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 192 affected / 239 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 37 affected / 239 at risk

Adverse event: Injection site erosion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 239 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 22 affected / 239 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 239 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 239 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 239 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 239 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 239 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 239 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 239 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 239 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 85 affected / 239 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 239 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 239 at risk

Adverse event: Allergic bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 118 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 118 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 112 affected / 118 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 30 affected / 118 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 83 affected / 118 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 12 affected / 118 at risk

Adverse event: Fever (rectal temperature ≥ 38.5°C)
Serious: no
Organ System: General disorders
Frequency: 105 affected / 118 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 88 affected / 118 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 15 affected / 118 at risk

Adverse event: Injection site erosion
Serious: no
Organ System: General disorders
Frequency: 6 affected / 118 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 20 affected / 118 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 118 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 118 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 118 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 118 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 118 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 118 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 118 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 118 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 118 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 118 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 118 at risk