Study: NCT01776554

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 329 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 329 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 329 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 44 affected / 329 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 60 affected / 329 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 23 affected / 329 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 45 affected / 329 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 209 affected / 329 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 40 affected / 329 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 48 affected / 329 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 329 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 329 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 329 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 329 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 329 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 329 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 329 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 329 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 49 affected / 329 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 329 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 329 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 329 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 329 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 329 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Apnoeic attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 329 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 50 affected / 329 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 54 affected / 329 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 19 affected / 329 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 39 affected / 329 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 213 affected / 329 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 38 affected / 329 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 329 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 329 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 329 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 329 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 329 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 329 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 329 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 329 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 329 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 329 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 658 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 658 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 658 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 658 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 658 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 658 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 658 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 658 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 658 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 658 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 658 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 658 at risk

Adverse event: Apnoeic attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 658 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 658 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 94 affected / 658 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 114 affected / 658 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 42 affected / 658 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 84 affected / 658 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 422 affected / 658 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 78 affected / 658 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 80 affected / 658 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 658 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 113 affected / 658 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 43 affected / 658 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 658 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 95 affected / 658 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 658 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 83 affected / 658 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 49 affected / 658 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 96 affected / 658 at risk