Study: NCT00943202

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 133 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 133 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 133 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 133 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 133 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 133 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 133 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 22 affected / 35 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: 9 affected / 35 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: 14 affected / 35 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 25 affected / 98 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 10 to 17 years only.
Frequency: 24 affected / 49 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: 21 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 40 affected / 98 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 / 98 at risk

Adverse event: Decreased activity
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 27 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 133 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 133 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 83 affected / 133 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 75 affected / 133 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: 35 affected / 133 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: 37 affected / 133 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 133 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 133 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 133 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 133 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 8 affected / 133 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 133 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 133 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 133 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 133 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 20 affected / 33 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: 8 affected / 33 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: 7 affected / 33 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 / 100 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 10 to 17 years only.
Frequency: 15 affected / 49 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: 15 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 27 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 18 affected / 100 at risk

Adverse event: Decreased activity
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 21 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 133 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 67 affected / 133 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 82 affected / 133 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 68 affected / 133 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: 39 affected / 133 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: 45 affected / 133 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 133 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 133 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 6 affected / 133 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 133 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 133 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 133 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 133 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 23 affected / 35 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: 11 affected / 35 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: 10 affected / 35 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 20 affected / 98 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 10 to 17 years only.
Frequency: 13 affected / 49 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: 23 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 33 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 19 affected / 98 at risk

Adverse event: Decreased activity
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 26 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 133 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 75 affected / 133 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 91 affected / 133 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 76 affected / 133 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: 39 affected / 133 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: 43 affected / 133 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 132 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 132 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 132 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 4 affected / 132 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 132 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 132 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 132 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 132 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 132 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 132 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 132 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 6 to less than 36 months only.
Frequency: 17 affected / 28 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: 13 affected / 28 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: 9 affected / 28 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 15 affected / 104 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 10 to 17 years only.
Frequency: 14 affected / 53 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: 19 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 27 affected / 104 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 13 affected / 104 at risk

Adverse event: Decreased activity
Serious: no
Organ System: General disorders
Notes: Solicited from participants aged 36 months to 17 years only.
Frequency: 21 affected / 104 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 132 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 65 affected / 132 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 90 affected / 132 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 72 affected / 132 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: 51 affected / 132 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: 53 affected / 132 at risk