Study: NCT00824655

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

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

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 108 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 99 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 104 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 104 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 101 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 107 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 107 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 99 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Frequency: 27 affected / 103 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 39 affected / 107 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 92 affected / 114 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Frequency: 54 affected / 106 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Frequency: 44 affected / 112 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 118 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 118 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 116 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 116 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 116 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 116 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Limb mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 116 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 62 affected / 104 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 96 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 56 affected / 104 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 52 affected / 104 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 100 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 104 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 54 affected / 103 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 98 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Frequency: 31 affected / 99 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Frequency: 5 affected / 96 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 48 affected / 103 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 91 affected / 111 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Frequency: 50 affected / 101 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Frequency: 38 affected / 105 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 116 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 116 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 116 at risk

Adverse event: Foreign body
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Obstructive airways disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 110 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 103 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 60 affected / 110 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 109 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 105 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 67 affected / 113 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 113 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 106 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Frequency: 34 affected / 105 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Frequency: 4 affected / 102 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 48 affected / 109 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 86 affected / 113 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Frequency: 42 affected / 108 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Frequency: 35 affected / 106 at risk