Study: NCT00661713

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 128 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 128 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 128 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 93 affected / 128 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 72 affected / 128 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 122 affected / 128 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 73 affected / 128 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 92 affected / 128 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 128 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 128 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 128 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 128 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 128 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 128 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 128 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 56 affected / 128 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 85 affected / 128 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 79 affected / 128 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 247 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 247 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 247 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 247 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 162 affected / 247 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 130 affected / 247 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 236 affected / 247 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 132 affected / 247 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 181 affected / 247 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 247 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 247 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 247 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 247 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 247 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 247 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 247 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 76 affected / 247 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 141 affected / 247 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 140 affected / 247 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 128 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 128 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 97 affected / 128 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 76 affected / 128 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 124 affected / 128 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 81 affected / 128 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 96 affected / 128 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 128 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 128 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 128 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 128 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 128 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 128 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 128 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 128 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 91 affected / 128 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 128 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 247 at risk

Adverse event: Glomerulonephritis minimal lesion
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 247 at risk

Adverse event: Testicular torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 247 at risk

Adverse event: Adenoidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 247 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 247 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 72 affected / 247 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 188 affected / 247 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 151 affected / 247 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 237 affected / 247 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 144 affected / 247 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 172 affected / 247 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 247 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 247 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 247 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 247 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 247 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 247 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 247 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 81 affected / 247 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 158 affected / 247 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 160 affected / 247 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 127 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 94 affected / 127 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 82 affected / 127 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 113 affected / 127 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 76 affected / 127 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 87 affected / 127 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 127 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 127 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 127 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 127 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 127 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 127 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 127 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 127 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 82 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 74 affected / 127 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: SHIGELLAIN FECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: TOXICITY TO VARlOUS AGENTS
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 253 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 89 affected / 253 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 172 affected / 253 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 122 affected / 253 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 236 affected / 253 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 115 affected / 253 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 185 affected / 253 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 253 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 253 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 253 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 253 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 253 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 253 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 253 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 105 affected / 253 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 160 affected / 253 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 165 affected / 253 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 373 at risk

Adverse event: MENINGITIS BACTERlAL
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 373 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 373 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 373 at risk

Adverse event: Juvenile idiopathic arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 373 at risk

Adverse event: BENGIN OVARIAN TUMOUR
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 373 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 373 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 373 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 373 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 143 affected / 373 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 282 affected / 373 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 228 affected / 373 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 345 affected / 373 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 226 affected / 373 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 272 affected / 373 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 373 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 373 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 373 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 373 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 373 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 373 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 373 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 146 affected / 373 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 238 affected / 373 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 244 affected / 373 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: Adenoma benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 128 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 128 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 128 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 86 affected / 128 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 58 affected / 128 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 123 affected / 128 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 55 affected / 128 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 89 affected / 128 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 128 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 128 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 128 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 128 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 128 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 128 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 128 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 128 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 91 affected / 128 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 76 affected / 128 at risk