Study: NCT02955797

Adverse event: Haemolytic uraemic syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Intestinal malrotation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 303 at risk

Adverse event: Gastroenteritis Escherichia coli
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 303 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 303 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 303 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 106 affected / 303 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 122 affected / 303 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 122 affected / 303 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 63 affected / 303 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 40 affected / 303 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 303 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 303 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 303 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 303 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 91 affected / 303 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 64 affected / 303 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 144 affected / 303 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 303 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 306 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 306 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 306 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 306 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 111 affected / 306 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 116 affected / 306 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 113 affected / 306 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 52 affected / 306 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 48 affected / 306 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 306 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 306 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 306 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 306 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 94 affected / 306 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 306 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 127 affected / 306 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 306 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 203 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 203 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 203 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 203 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 203 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 48 affected / 203 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 52 affected / 203 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 55 affected / 203 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 35 affected / 203 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 29 affected / 203 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 203 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 203 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 203 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 203 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 56 affected / 203 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 203 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 76 affected / 203 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 203 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Blood immunoglobulin A decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 102 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 102 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 102 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 102 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 23 affected / 102 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 21 affected / 102 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 102 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 102 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 102 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 102 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 102 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 102 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 36 affected / 102 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 102 at risk