Study: NCT01041573

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 871 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 871 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 871 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 871 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 871 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 871 at risk

Adverse event: Hepatitis A
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 871 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 871 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 871 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 326 affected / 871 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 871 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 77 affected / 871 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 122 affected / 871 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 871 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 871 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 871 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: pain without touching, solicited local
Frequency: 15 affected / 256 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: pain upon touching, solicited local
Frequency: 38 affected / 871 at risk

Adverse event: Hardening
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 10 affected / 871 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 34 affected / 871 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 81 affected / 871 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 21 affected / 268 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: solicited systemic
Frequency: 10 affected / 233 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 244 affected / 871 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 87 affected / 871 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: solicited systemic
Frequency: 58 affected / 871 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: solicited systemic
Frequency: 94 affected / 871 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: solicited systemic
Frequency: 49 affected / 871 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: solicited systemic
Frequency: 65 affected / 871 at risk

Adverse event: Excessive Fatigue
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 28 affected / 871 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Typhoid fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 540 at risk

Adverse event: Kawasaki´s Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 540 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 540 at risk

Adverse event: Strabismus
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 540 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 540 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 540 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 67 affected / 540 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 540 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 540 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 35 affected / 540 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 540 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 540 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 540 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: pain without touching, solicited local
Frequency: 65 affected / 532 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: pain upon touching, solicited local
Frequency: 48 affected / 540 at risk

Adverse event: Hardening
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 8 affected / 540 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 14 affected / 540 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 22 affected / 540 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 16 affected / 532 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: solicited systemic
Frequency: 31 affected / 531 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 61 affected / 540 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 6 affected / 540 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: solicited systemic
Frequency: 10 affected / 540 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: solicited systemic
Frequency: 6 affected / 540 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: solicited systemic
Frequency: 5 affected / 540 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: solicited systemic
Frequency: 11 affected / 540 at risk

Adverse event: Excessive Fatigue
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 12 affected / 540 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 394 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 394 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Familial periodic paralysis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 394 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 394 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 394 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 97 affected / 394 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 394 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 394 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 394 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 394 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 394 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 394 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: pain without touching, solicited local
Frequency: 20 affected / 228 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: pain upon touching, solicited local
Frequency: 27 affected / 394 at risk

Adverse event: Hardening
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 2 affected / 394 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 12 affected / 394 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 25 affected / 394 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 16 affected / 235 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: solicited systemic
Frequency: 10 affected / 219 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 49 affected / 394 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 16 affected / 394 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: solicited systemic
Frequency: 13 affected / 394 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: solicited systemic
Frequency: 13 affected / 394 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: solicited systemic
Frequency: 6 affected / 394 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: solicited systemic
Frequency: 13 affected / 394 at risk

Adverse event: Excessive Fatigue
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 5 affected / 394 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 64 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 64 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 64 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 64 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 64 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: pain upon touching, solicited local
Frequency: 8 affected / 63 at risk

Adverse event: Hardening
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 5 affected / 63 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 5 affected / 63 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: solicited local
Frequency: 23 affected / 63 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 24 affected / 63 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 9 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: solicited systemic
Frequency: 5 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: solicited systemic
Frequency: 6 affected / 63 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: solicited systemic
Frequency: 9 affected / 63 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: solicited systemic
Frequency: 6 affected / 63 at risk

Adverse event: Excessive Fatigue
Serious: no
Organ System: General disorders
Notes: solicited systemic
Frequency: 5 affected / 63 at risk