Study: NCT00778895

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed within the 28-day post vaccination period.
Frequency: 1 affected / 164 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed through the 6-month safety follow-up period.
Frequency: 1 affected / 164 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 45 affected / 161 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 49 affected / 161 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 22 affected / 161 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 54 affected / 161 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 81 affected / 161 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 50 affected / 161 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 161 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 164 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 164 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 164 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 164 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 164 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 164 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 164 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 164 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed within the 28-day post vaccination period.
Frequency: 1 affected / 167 at risk

Adverse event: Viral pharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed through the 6-month safety follow-up period.
Frequency: 1 affected / 167 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 55 affected / 164 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 54 affected / 164 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 24 affected / 164 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 65 affected / 163 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 83 affected / 163 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 54 affected / 163 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 163 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 167 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 167 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 167 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 167 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 167 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 167 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 167 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 167 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 43 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 13 affected / 43 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 43 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 16 affected / 43 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 22 affected / 43 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 14 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 43 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 43 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 43 at risk