Study: NCT00944073

Adverse event: Cleft palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 292 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 292 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 292 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 292 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 292 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 292 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 292 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 292 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 48 affected / 94 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 33 affected / 94 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 21 affected / 94 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 22 affected / 198 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 10 to 17 years only.
Frequency: 18 affected / 98 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 24 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 52 affected / 198 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 25 affected / 198 at risk

Adverse event: Decreased activity
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 32 affected / 198 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 292 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 101 affected / 292 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 135 affected / 292 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 89 affected / 292 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 54 affected / 292 at risk

Adverse event: Injection site swelling (measured)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 50 affected / 292 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 291 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 291 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 291 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 291 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 291 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 291 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 291 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 291 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 291 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 291 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 291 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 55 affected / 98 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 22 affected / 98 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 25 affected / 98 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 21 affected / 193 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 10 to 17 years only.
Frequency: 30 affected / 96 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 32 affected / 193 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 53 affected / 193 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 33 affected / 198 at risk

Adverse event: Decreased activity
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 39 affected / 193 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 291 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 108 affected / 291 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 141 affected / 291 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 91 affected / 291 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 48 affected / 291 at risk

Adverse event: Injection site swelling (measured)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 46 affected / 291 at risk