Study: NCT00326118

Adverse event: Breath holding
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 324 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 324 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 324 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 324 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 324 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 324 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 324 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 37 affected / 324 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 324 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 324 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 324 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 324 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 324 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 324 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 91 affected / 324 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 146 affected / 324 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 78 affected / 324 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 102 affected / 324 at risk

Adverse event: Fever (above or equal to 38 degrees Celsius)
Serious: no
Organ System: General disorders
Frequency: 76 affected / 324 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 154 affected / 324 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 102 affected / 324 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 109 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 109 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 109 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 109 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 109 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 109 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 109 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 109 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 10 affected / 109 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 109 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 9 affected / 109 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 42 affected / 109 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 64 affected / 109 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 41 affected / 109 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 40 affected / 109 at risk

Adverse event: Fever (above or equal to 38 degrees Celsius)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 109 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 69 affected / 109 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 40 affected / 109 at risk