Study: NCT01248884

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 240 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 240 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 240 at risk

Adverse event: Asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 240 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 240 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 240 at risk

Adverse event: Respiratory tract congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 240 at risk

Adverse event: Scaphocephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 240 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 240 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 240 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 22 affected / 240 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 240 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 240 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 240 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 240 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 240 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 190 affected / 240 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 151 affected / 240 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 124 affected / 240 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 188 affected / 240 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 197 affected / 240 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 135 affected / 240 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 180 affected / 240 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Haemangioma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 242 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 242 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 14 affected / 242 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 242 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 242 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 242 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 242 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 242 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 183 affected / 240 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 140 affected / 240 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 122 affected / 240 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 185 affected / 240 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 205 affected / 240 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 127 affected / 240 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 173 affected / 242 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 239 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 239 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 25 affected / 239 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 239 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 239 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 239 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 239 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 239 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 155 affected / 238 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 128 affected / 238 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 115 affected / 238 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 171 affected / 238 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 191 affected / 238 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 112 affected / 238 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 140 affected / 239 at risk