Study: NCT01379937

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

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

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

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

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

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 127 affected / 156 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 15 affected / 156 at risk

Adverse event: Diarrhoea/vomiting
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 2 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 5 affected / 30 at risk

Adverse event: Irritability / fussiness
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 8 affected / 30 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 8 affected / 30 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 12 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 33 affected / 126 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 28 affected / 126 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 16 affected / 126 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 63 affected / 126 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 29 affected / 126 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 23 affected / 126 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 31 affected / 156 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 2 affected / 156 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 5 affected / 156 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 45 affected / 156 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 3 affected / 156 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 10 affected / 156 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 129 affected / 156 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 156 at risk

Adverse event: Diarrhoea/vomiting
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 3 affected / 31 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 8 affected / 31 at risk

Adverse event: Irritability / fussiness
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 10 affected / 31 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 9 affected / 31 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 11 affected / 31 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 31 affected / 125 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 22 affected / 125 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 12 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 52 affected / 125 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 33 affected / 125 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 19 affected / 125 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 54 affected / 156 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 10 affected / 156 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 5 affected / 156 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 63 affected / 156 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 8 affected / 156 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 20 affected / 156 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 73 affected / 104 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 104 at risk

Adverse event: Diarrhoea/vomiting
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 2 affected / 22 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 3 affected / 22 at risk

Adverse event: Irritability / fussiness
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 3 affected / 22 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 3 affected / 22 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 1 affected / 22 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 11 affected / 82 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 10 affected / 82 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 8 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 20 affected / 82 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 13 affected / 82 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 10 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 9 affected / 104 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 7 affected / 104 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 6 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 31 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 3 affected / 104 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 18 affected / 104 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 53 affected / 104 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 104 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 2 affected / 24 at risk

Adverse event: Irritability / fussiness
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 1 affected / 24 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged less than 6 years.
Frequency: 1 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 11 affected / 80 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 10 affected / 80 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 7 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 24 affected / 80 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 13 affected / 80 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: AE reported for subjects aged 6 years or more.
Frequency: 7 affected / 80 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 9 affected / 104 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 2 affected / 104 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: AE reported within 21 days post-vaccination.
Frequency: 2 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 27 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 6 affected / 104 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: AE reported from Day 0 up to Day 84 post-vaccination.
Frequency: 10 affected / 104 at risk