Study: NCT01536405

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 682 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 682 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 682 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 682 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 682 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 682 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 682 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 682 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 682 at risk

Adverse event: Vulval abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 682 at risk

Adverse event: Exposure via direct contact
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 682 at risk

Adverse event: Exposure via ingestion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 682 at risk

Adverse event: Foreign body aspiration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 682 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 682 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 682 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 682 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 682 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 682 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 682 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 682 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 682 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 48 affected / 682 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 682 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 682 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 254 affected / 682 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 208 affected / 682 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 156 affected / 682 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 225 affected / 682 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 682 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 682 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 128 affected / 682 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 682 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 682 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 159 affected / 682 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 682 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 87 affected / 682 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 58 affected / 682 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 62 affected / 682 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 682 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 683 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 683 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 683 at risk

Adverse event: Cellulitis staphylcoccal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 683 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 683 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 683 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 683 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 683 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 683 at risk

Adverse event: Pharyngitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 683 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 683 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 683 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 683 at risk

Adverse event: Juvenile idiopathic arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 683 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 683 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 683 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 683 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 683 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 683 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 683 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 46 affected / 683 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 91 affected / 683 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 683 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 199 affected / 683 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 187 affected / 683 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 123 affected / 683 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 235 affected / 683 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 683 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 683 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 128 affected / 683 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 683 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 683 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 163 affected / 683 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 683 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 101 affected / 683 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 683 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 77 affected / 683 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 683 at risk