Study: NCT00127855

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 2 affected / 82 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 19 affected / 82 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 12 affected / 82 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following primary vaccination
Frequency: 13 affected / 82 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 6 affected / 82 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 6 affected / 82 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 6 affected / 82 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 7 affected / 82 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 7 affected / 82 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 4 affected / 82 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Following primary vaccination
Frequency: 8 affected / 82 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 3 affected / 82 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Following primary vaccination
Frequency: 4 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 12 affected / 80 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 7 affected / 80 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following challenge dose administration
Frequency: 5 affected / 80 at risk

Adverse event: Rhinorhea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 4 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 2 affected / 80 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 2 affected / 80 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 4 affected / 80 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 2 affected / 80 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 5 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 4 affected / 80 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 54 affected / 81 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 67 affected / 81 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 53 affected / 81 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 65 affected / 81 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 76 affected / 81 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 57 affected / 81 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 65 affected / 81 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 19 affected / 80 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 39 affected / 80 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 15 affected / 80 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 26 affected / 80 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 48 affected / 80 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 26 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 29 affected / 80 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 24 affected / 82 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 12 affected / 82 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following primary vaccination
Frequency: 6 affected / 82 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 9 affected / 82 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 9 affected / 82 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 10 affected / 82 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 8 affected / 82 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 6 affected / 82 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 5 affected / 82 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Following primary vaccination
Frequency: 2 affected / 82 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 3 affected / 82 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 4 affected / 82 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 3 affected / 82 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Following primary vaccination
Frequency: 6 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 10 affected / 79 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 9 affected / 79 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following challenge dose administration
Frequency: 6 affected / 79 at risk

Adverse event: Rhinorhea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 6 affected / 79 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 4 affected / 79 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 5 affected / 79 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 4 affected / 79 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 6 affected / 79 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 3 affected / 79 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 1 affected / 79 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Following challenge dose administration
Frequency: 1 affected / 79 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 50 affected / 82 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 67 affected / 82 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 64 affected / 82 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 72 affected / 82 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 79 affected / 82 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 56 affected / 82 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 64 affected / 82 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 15 affected / 79 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 27 affected / 79 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 15 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 25 affected / 79 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 48 affected / 79 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 27 affected / 79 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 20 affected / 79 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 80 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Following primary vaccination
Frequency: 1 affected / 80 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 24 affected / 80 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 15 affected / 80 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following primary vaccination
Frequency: 9 affected / 80 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 4 affected / 80 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 7 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 6 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 3 affected / 80 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 3 affected / 80 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 4 affected / 80 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Following primary vaccination
Frequency: 7 affected / 80 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 3 affected / 80 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 3 affected / 80 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 4 affected / 80 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Following primary vaccination
Frequency: 2 affected / 80 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 14 affected / 77 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 3 affected / 77 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following challenge dose administration
Frequency: 8 affected / 77 at risk

Adverse event: Rhinorhea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 5 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 10 affected / 77 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 4 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 3 affected / 77 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 3 affected / 77 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 3 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 2 affected / 77 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 4 affected / 77 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Following challenge dose administration
Frequency: 1 affected / 77 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 53 affected / 79 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 64 affected / 79 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 56 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 58 affected / 78 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 76 affected / 78 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 49 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 64 affected / 78 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 18 affected / 77 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 27 affected / 77 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 13 affected / 77 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 17 affected / 77 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 45 affected / 77 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 25 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 27 affected / 77 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Following primary vaccination
Frequency: 1 affected / 81 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Following primary vaccination
Frequency: 1 affected / 81 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 81 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 81 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Following primary vaccination
Frequency: 1 affected / 81 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 25 affected / 81 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 16 affected / 81 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following primary vaccination
Frequency: 5 affected / 81 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 10 affected / 81 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 3 affected / 81 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 7 affected / 81 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 2 affected / 81 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 2 affected / 81 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 5 affected / 81 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Following primary vaccination
Frequency: 3 affected / 81 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 5 affected / 81 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 3 affected / 81 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 17 affected / 81 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 7 affected / 81 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following challenge dose administration
Frequency: 6 affected / 81 at risk

Adverse event: Rhinorhea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 7 affected / 81 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 3 affected / 81 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 6 affected / 81 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 3 affected / 81 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 3 affected / 81 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 1 affected / 81 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 5 affected / 81 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Following challenge dose administration
Frequency: 1 affected / 81 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 66 affected / 81 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 75 affected / 81 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 60 affected / 81 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 70 affected / 81 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 80 affected / 81 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 47 affected / 81 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 64 affected / 81 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 17 affected / 81 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 44 affected / 81 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 15 affected / 81 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 26 affected / 81 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 46 affected / 81 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 24 affected / 81 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 36 affected / 81 at risk

Adverse event: Balanoposthitis
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 4 affected / 82 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 1 affected / 82 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 1 affected / 77 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 1 affected / 77 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 31 affected / 82 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 11 affected / 82 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following primary vaccination
Frequency: 12 affected / 82 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 6 affected / 82 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 9 affected / 82 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 4 affected / 82 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 8 affected / 82 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 7 affected / 82 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following primary vaccination
Frequency: 4 affected / 82 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Following primary vaccination
Frequency: 2 affected / 82 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following primary vaccination
Frequency: 2 affected / 82 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Following primary vaccination
Frequency: 5 affected / 82 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Following primary vaccination
Frequency: 4 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 11 affected / 77 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 7 affected / 77 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Following challenge dose administration
Frequency: 6 affected / 77 at risk

Adverse event: Rhinorhea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 5 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 6 affected / 77 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 7 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Following challenge dose administration
Frequency: 5 affected / 77 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Following challenge dose administration
Frequency: 3 affected / 77 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Following challenge dose administration
Frequency: 3 affected / 77 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Following challenge dose administration
Frequency: 4 affected / 77 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 60 affected / 82 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 69 affected / 82 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 58 affected / 82 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 67 affected / 82 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 80 affected / 82 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 58 affected / 82 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following primary vaccination
Frequency: 70 affected / 82 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 16 affected / 77 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 29 affected / 77 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 12 affected / 77 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 18 affected / 77 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 49 affected / 77 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 23 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Following challenge dose administration
Frequency: 34 affected / 77 at risk