Study: NCT00197002

Adverse event: Bronchiolitis (enrollment phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 177 at risk

Adverse event: Convulsion (enrollment phase)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 177 at risk

Adverse event: Gastroenteritis (enrollment phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 177 at risk

Adverse event: Otitis media acute (enrollment phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 177 at risk

Adverse event: Upper respiratory tract infection (enrollment phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 177 at risk

Adverse event: Convulsion (active phase)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Croup infectious (active phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 147 at risk

Adverse event: Kawasaki's disease (active phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 147 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 57 affected / 141 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 45 affected / 141 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 19 affected / 141 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 48 affected / 141 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 141 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 60 affected / 141 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 42 affected / 141 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 147 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 147 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 147 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 147 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 147 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Convulsion (enrollment phase)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Croup infectious (active phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 137 at risk

Adverse event: Pneumonia (active phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 137 at risk

Adverse event: Dehydration (active phase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 137 at risk

Adverse event: Developmental delay (active phase)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 137 at risk

Adverse event: Gait disturbance (active phase)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 137 at risk

Adverse event: Hearing impaired (active phase)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 137 at risk

Adverse event: Hypoxia (active phase)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 137 at risk

Adverse event: Langerhans' cell granulomatosis (active phase)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 137 at risk

Adverse event: Gastroenteritis viral (ESFU phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: Pneumonia (ESFU phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 62 affected / 133 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 64 affected / 133 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 47 affected / 133 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 49 affected / 133 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 24 affected / 133 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 65 affected / 133 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 45 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 137 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 137 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 137 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 137 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 137 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 137 at risk

Adverse event: Burns second degree (enrolllment phase)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 175 at risk

Adverse event: Lactose intolerance (enrollment phase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 175 at risk

Adverse event: Convulsion (active phase)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 149 at risk

Adverse event: Bronchial hyperactivity (active phase)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 149 at risk

Adverse event: Bronchiolitis (active phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 149 at risk

Adverse event: Diabetes mellitus insulin-dependent (active phase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 149 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 149 at risk

Adverse event: Dehydration (ESFU phase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 132 at risk

Adverse event: Gastroenteritis viral (ESFU phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Kawasaki's disease (ESFU phase)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 76 affected / 142 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 78 affected / 142 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 48 affected / 142 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 63 affected / 142 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 31 affected / 142 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 82 affected / 142 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 54 affected / 142 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 149 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 149 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 149 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 149 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 149 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 149 at risk