Study: NCT02141204

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 224 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 224 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 224 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 224 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 224 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 224 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 224 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 224 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 224 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 87 affected / 224 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 224 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 224 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 224 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 224 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 87 affected / 224 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 224 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 224 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 224 at risk

Adverse event: Intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 224 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 224 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 225 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 225 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Abnormal faeces
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 225 at risk

Adverse event: Faeces discoloured
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Oral disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 225 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 2 affected / 225 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 225 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 12 affected / 225 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 91 affected / 225 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 225 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 225 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 225 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 53 affected / 225 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 102 affected / 225 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 225 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 225 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 225 at risk