Study: NCT02184572

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1164 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1164 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Salmonellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1164 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1164 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1164 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1164 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1164 at risk

Adverse event: Joint effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1164 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1164 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1164 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1164 at risk

Adverse event: Obstructive airways disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1164 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1164 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 95 affected / 1164 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 1164 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 284 affected / 1164 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 313 affected / 1164 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 105 affected / 1164 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 350 affected / 1164 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 86 affected / 1164 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 111 affected / 1164 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 495 affected / 1164 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 529 affected / 1164 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 723 affected / 1164 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 80 affected / 1164 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 275 affected / 1164 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 572 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 572 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 572 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 572 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 572 at risk

Adverse event: Fungal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 572 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 572 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 572 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 572 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 572 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 572 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 572 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 143 affected / 572 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 133 affected / 572 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 61 affected / 572 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 180 affected / 572 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 572 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 572 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 233 affected / 572 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 238 affected / 572 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 348 affected / 572 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 572 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 152 affected / 572 at risk