Study: NCT00645411

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 652 at risk

Adverse event: Appendix disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 652 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 652 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 652 at risk

Adverse event: Body height below normal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 652 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 652 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 652 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 57 affected / 652 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 91 affected / 652 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 44 affected / 652 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 220 affected / 652 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 34 affected / 652 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 60 affected / 652 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 652 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 99 affected / 652 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 99 affected / 652 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 652 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 316 at risk

Adverse event: Adnexal torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 316 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 41 affected / 316 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 45 affected / 316 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 28 affected / 316 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 120 affected / 316 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 10 affected / 316 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 34 affected / 316 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 316 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 59 affected / 316 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 316 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 316 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1599 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1599 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 155 affected / 1599 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 197 affected / 1599 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 87 affected / 1599 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 451 affected / 1599 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 98 affected / 1599 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 103 affected / 1599 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 88 affected / 1599 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 141 affected / 1599 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 143 affected / 1599 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 124 affected / 1599 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 119 affected / 1013 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 138 affected / 1013 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 44 affected / 1013 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 251 affected / 1013 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 60 affected / 1013 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 78 affected / 1013 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 73 affected / 1013 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 76 affected / 1013 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 111 affected / 1013 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 75 affected / 1013 at risk

Adverse event: Thalassaemia beta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1557 at risk

Adverse event: Gastroentritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1557 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1557 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1557 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1557 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1557 at risk

Adverse event: Eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1557 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1557 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 99 affected / 1557 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 209 affected / 1557 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 66 affected / 1557 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 421 affected / 1557 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 52 affected / 1557 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 76 affected / 1557 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 63 affected / 1557 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 100 affected / 1557 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 94 affected / 1557 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 70 affected / 1557 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 977 at risk

Adverse event: Gastroentritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 977 at risk

Adverse event: Otitis media chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 977 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 977 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 977 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 977 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 82 affected / 977 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 118 affected / 977 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 51 affected / 977 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 266 affected / 977 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 43 affected / 977 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 50 affected / 977 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 44 affected / 977 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 67 affected / 977 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 73 affected / 977 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 977 at risk