Study: NCT00343889

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 190 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 190 at risk

Adverse event: Bullus impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 190 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 190 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 190 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 190 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 190 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 190 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 189 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 123 affected / 189 at risk

Adverse event: Injection site erythemia
Serious: no
Organ System: General disorders
Frequency: 121 affected / 189 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 60 affected / 189 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 85 affected / 189 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 190 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 189 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 189 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 89 affected / 190 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 190 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 56 affected / 189 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 102 affected / 189 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 189 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 189 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 189 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 152 affected / 189 at risk

Adverse event: Injection site erythemia
Serious: no
Organ System: General disorders
Frequency: 148 affected / 189 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 107 affected / 189 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 129 affected / 189 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 189 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 67 affected / 189 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 63 affected / 189 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 113 affected / 189 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 189 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 97 affected / 189 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 128 affected / 189 at risk