Study: NCT00871338

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 142 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 142 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Developmental delay
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 142 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 142 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the primary phase.
Frequency: 42 affected / 142 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the primary phase.
Frequency: 31 affected / 142 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the primary phase.
Frequency: 19 affected / 142 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the primary phase.
Frequency: 21 affected / 142 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the primary phase.
Frequency: 13 affected / 142 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Symptom reported during the primary phase.
Frequency: 7 affected / 142 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Symptom reported during the primary phase.
Frequency: 7 affected / 142 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the primary phase.
Frequency: 6 affected / 142 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the booster phase.
Frequency: 28 affected / 139 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 7 affected / 139 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the booster phase.
Frequency: 11 affected / 139 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the booster phase.
Frequency: 5 affected / 139 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the booster phase.
Frequency: 5 affected / 139 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 57 affected / 142 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 86 affected / 142 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 60 affected / 142 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 24 affected / 142 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 76 affected / 142 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 35 affected / 142 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 103 affected / 142 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 122 affected / 142 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 79 affected / 142 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 59 affected / 142 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 43 affected / 136 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 75 affected / 136 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 41 affected / 136 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 18 affected / 136 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 142 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Cerebral atrophy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 142 at risk

Adverse event: Lymph node abscess
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the primary phase.
Frequency: 35 affected / 142 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the primary phase.
Frequency: 29 affected / 142 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the primary phase.
Frequency: 18 affected / 142 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the primary phase.
Frequency: 14 affected / 142 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the primary phase.
Frequency: 18 affected / 142 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Symptom reported during the primary phase.
Frequency: 15 affected / 142 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Symptom reported during the primary phase.
Frequency: 14 affected / 142 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the primary phase.
Frequency: 8 affected / 142 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the booster phase.
Frequency: 23 affected / 142 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 9 affected / 142 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the booster phase.
Frequency: 2 affected / 142 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom reported during the booster phase.
Frequency: 7 affected / 142 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom reported during the booster phase.
Frequency: 7 affected / 142 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 57 affected / 141 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 77 affected / 141 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 48 affected / 141 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 11 affected / 134 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 56 affected / 134 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 20 affected / 134 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 103 affected / 141 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 117 affected / 141 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 77 affected / 141 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom reported during the primary phase.
Frequency: 49 affected / 141 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 40 affected / 134 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 66 affected / 134 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 40 affected / 134 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom reported during the booster phase.
Frequency: 20 affected / 134 at risk