Study: NCT02035696

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 174 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 174 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 174 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 174 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 20 affected / 174 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 30 affected / 174 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 9 affected / 174 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 13 affected / 174 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 56 affected / 174 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 174 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 174 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 174 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 174 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 174 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 174 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 174 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 7 affected / 174 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 174 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 174 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 174 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 166 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 166 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 166 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 166 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 166 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 166 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 166 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 38 affected / 166 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 36 affected / 166 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 10 affected / 166 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 16 affected / 166 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 48 affected / 166 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 166 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 166 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 166 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 166 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 166 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 166 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 166 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 166 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 166 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 166 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 166 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 167 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 167 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 167 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 167 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 35 affected / 167 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 32 affected / 167 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 8 affected / 167 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 12 affected / 167 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 47 affected / 167 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 167 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 167 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 167 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 167 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 167 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 167 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 167 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 7 affected / 167 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 167 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 167 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 167 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 164 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 164 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 164 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 37 affected / 164 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 29 affected / 164 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 7 affected / 164 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 10 affected / 164 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 47 affected / 164 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 164 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 164 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 164 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 164 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 164 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 164 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 164 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 164 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 164 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 164 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 164 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 671 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 671 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 671 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 671 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 671 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 671 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 671 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 671 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 671 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 671 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 671 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 671 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 130 affected / 671 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 671 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 130 affected / 671 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 127 affected / 671 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 34 affected / 671 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 51 affected / 671 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 198 affected / 671 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 104 affected / 671 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 83 affected / 671 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 97 affected / 671 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 186 affected / 671 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 103 affected / 671 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 121 affected / 671 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 134 affected / 671 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 28 affected / 671 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 671 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 671 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 671 at risk