Study: NCT01196988

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 915 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 915 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 915 at risk

Adverse event: Gastroenteritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 915 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 915 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 915 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 915 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 915 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 915 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 915 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 915 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 915 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 40 affected / 915 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 915 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 915 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 129 affected / 613 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 66 affected / 613 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 110 affected / 613 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 69 affected / 613 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 116 affected / 613 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 48 affected / 613 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 65 affected / 291 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 67 affected / 291 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 59 affected / 291 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 444 affected / 903 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 225 affected / 903 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 196 affected / 903 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 50 affected / 291 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 44 affected / 613 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 912 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 912 at risk

Adverse event: Abdominal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 912 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 912 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 912 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 912 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 912 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 912 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 912 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 912 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 118 affected / 589 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 62 affected / 589 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 125 affected / 589 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 63 affected / 589 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 106 affected / 589 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 60 affected / 589 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 56 affected / 314 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 55 affected / 314 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 40 affected / 314 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 425 affected / 902 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 214 affected / 902 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 193 affected / 902 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 51 affected / 314 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 31 affected / 589 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 911 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 911 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 911 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 911 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 911 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 911 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 911 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 911 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 911 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 911 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 911 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 911 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 114 affected / 626 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 52 affected / 626 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 114 affected / 626 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 51 affected / 626 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 106 affected / 626 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 47 affected / 626 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 53 affected / 280 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 59 affected / 280 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 47 affected / 280 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 416 affected / 906 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 206 affected / 906 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 160 affected / 906 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 41 affected / 280 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: This result is for subjects 6 years old or older
Frequency: 37 affected / 626 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 277 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 277 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 277 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 277 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 277 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 277 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 277 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 277 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 277 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 277 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 119 affected / 277 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 84 affected / 277 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 83 affected / 277 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 116 affected / 277 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 100 affected / 277 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 67 affected / 277 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Notes: This result is for subjects younger than 6 years old
Frequency: 81 affected / 277 at risk