Study: NCT01974895

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 158 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 158 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 158 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 158 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 48 affected / 151 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 60 affected / 151 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Frequency: 76 affected / 151 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 49 affected / 151 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Assessed during the 7-day (Days 0-6) post-vaccination period
Frequency: 10 affected / 151 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Assessed duringthe 4-day (Days 0-3) post-vaccination period
Frequency: 7 affected / 151 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 158 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 158 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 158 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 158 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 158 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 158 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 158 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 156 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 48 affected / 148 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 56 affected / 148 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Frequency: 67 affected / 148 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 46 affected / 148 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Assessed during the 7-day (Days 0-6) post-vaccination period
Frequency: 10 affected / 148 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Assessed duringthe 4-day (Days 0-3) post-vaccination period
Frequency: 8 affected / 148 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 156 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 156 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 156 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 156 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 156 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 156 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 156 at risk