Study: NCT01001169

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 30 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 10 affected / 30 at risk

Adverse event: Drowsiness (6m-5y)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 24 at risk

Adverse event: Irritability (6m-5y)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 24 at risk

Adverse event: Loss of appetite (6m-5y)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 24 at risk

Adverse event: Fatigue (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Gastrointestinal (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Headache (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Shivering (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

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

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 30 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 16 affected / 30 at risk

Adverse event: Fatigue (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 30 at risk

Adverse event: Gastrointestinal (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Headache (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 30 at risk

Adverse event: Joint pain (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 30 at risk

Adverse event: Muscle aches (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 30 at risk

Adverse event: Shivering (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 30 at risk

Adverse event: Sweating (6y-9y + 10y-17y)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk