Study: NCT00401531

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 206 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 206 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 205 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 161 affected / 205 at risk

Adverse event: Injection Erythema
Serious: no
Organ System: General disorders
Frequency: 93 affected / 206 at risk

Adverse event: Injection Swelling
Serious: no
Organ System: General disorders
Frequency: 59 affected / 206 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 134 affected / 205 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 109 affected / 205 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 206 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 206 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 59 affected / 205 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 109 affected / 205 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 128 affected / 206 at risk

Adverse event: Eczema herpeticum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 206 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Urethritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 206 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 206 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 206 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 135 affected / 206 at risk

Adverse event: Injection Erythema
Serious: no
Organ System: General disorders
Frequency: 91 affected / 206 at risk

Adverse event: Injection Swelling
Serious: no
Organ System: General disorders
Frequency: 44 affected / 206 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 122 affected / 206 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 68 affected / 206 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 206 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 206 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 206 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 104 affected / 206 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 106 affected / 206 at risk