Study: NCT01196026

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 10 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 6 affected / 10 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 6 affected / 10 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 6 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: For subjects less than 6 years old
Frequency: 5 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Tooth discolouration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 28 affected / 43 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 33 affected / 43 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 23 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 8 affected / 43 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 16 affected / 43 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 20 affected / 43 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 14 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: For subjects less than 6 years old
Frequency: 14 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 44 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 23 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 19 affected / 23 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 11 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: For subjects less than 6 years old
Frequency: 4 affected / 11 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: For subjects less than 6 years old
Frequency: 3 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lip haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 43 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 43 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 10 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 7 affected / 43 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 15 affected / 43 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 14 affected / 43 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 6 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: For subjects less than 6 years old
Frequency: 11 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 43 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 24 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 9 affected / 24 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk