Study: NCT01139021

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Somnolence
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 22 affected / 67 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 67 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 16 affected / 67 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 47 affected / 67 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 63 affected / 67 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 35 affected / 67 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 67 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 67 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 67 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 67 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 67 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 67 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 67 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 67 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 67 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 67 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 67 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 67 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Somnolence
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 18 at risk

Adverse event: Speech disorder developmental
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 5 affected / 18 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 13 affected / 18 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 18 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 18 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 18 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 18 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Cholesteatoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Pneumonia Respiratory Syncytial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Somnolence
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 70 affected / 112 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 112 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 47 affected / 112 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 112 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 103 affected / 112 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 109 affected / 112 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 58 affected / 112 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 46 affected / 112 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 53 affected / 112 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 84 affected / 112 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 112 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 112 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 112 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 112 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 112 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 112 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 112 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 112 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 112 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 112 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 112 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 112 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 112 at risk