Study: NCT00383123

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2115 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2115 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2115 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2115 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2115 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2115 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2115 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2115 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2115 at risk

Adverse event: Salmonellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2115 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2115 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2115 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2115 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2115 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 102 affected / 2115 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 116 affected / 2115 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 100 affected / 2115 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Frequency: 1072 affected / 2115 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Frequency: 421 affected / 2115 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Frequency: 308 affected / 2115 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 160 affected / 2115 at risk

Adverse event: Axillary fever
Serious: no
Organ System: General disorders
Frequency: 152 affected / 2115 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 232 affected / 2115 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 131 affected / 2115 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 85 affected / 2115 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 285 affected / 2115 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 218 affected / 2115 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 410 affected / 2115 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Meningitis enteroviral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Pharyngitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1210 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1210 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1210 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Pneumomediastinum
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1210 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 86 affected / 1210 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 1210 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 81 affected / 1210 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Frequency: 526 affected / 1210 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Frequency: 233 affected / 1210 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Frequency: 152 affected / 1210 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 177 affected / 1210 at risk

Adverse event: Axillary fever
Serious: no
Organ System: General disorders
Frequency: 85 affected / 1210 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 246 affected / 1210 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 128 affected / 1210 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 1210 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 88 affected / 1210 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 76 affected / 1210 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 133 affected / 1210 at risk