Study: NCT02915302

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 949 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 949 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 949 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 949 at risk

Adverse event: Urticaria chronic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 949 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 949 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 115 affected / 949 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 302 affected / 949 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 210 affected / 949 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 430 affected / 949 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 117 affected / 949 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 151 affected / 949 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 69 affected / 949 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 249 affected / 949 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 292 affected / 949 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 431 affected / 949 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 109 affected / 949 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 949 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 992 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 992 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 992 at risk

Adverse event: Accidental exposure to product by child
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 992 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 992 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 992 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 109 affected / 992 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 321 affected / 992 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 228 affected / 992 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 473 affected / 992 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 138 affected / 992 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 164 affected / 992 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 70 affected / 992 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 267 affected / 992 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 294 affected / 992 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 458 affected / 992 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 107 affected / 992 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 992 at risk