Study: NCT00310856

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 64 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 64 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 41 affected / 64 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 38 affected / 64 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 64 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 57 affected / 64 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 64 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 64 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 64 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 61 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 33 affected / 61 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 35 affected / 61 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 35 affected / 61 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 45 affected / 61 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 61 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 61 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 61 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 50 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 39 affected / 50 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 31 affected / 50 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 34 affected / 50 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 38 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 50 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 50 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 50 at risk