Study: NCT02987972

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 350 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Infantile colic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Leukoplakia oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Pylorospasm
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 350 at risk

Adverse event: Serum sickness
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 350 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 350 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 350 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 350 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 350 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 350 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 350 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 350 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 350 at risk

Adverse event: Fontanelle bulging
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 350 at risk

Adverse event: Infantile spasms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 350 at risk

Adverse event: Obliterative bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 350 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 350 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 350 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 151 affected / 350 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 117 affected / 350 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 198 affected / 350 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 98 affected / 350 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 115 affected / 350 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 350 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 350 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 350 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 158 affected / 350 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 221 affected / 350 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 295 affected / 350 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 350 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 350 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 350 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 347 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Salmonellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 347 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 347 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Irritability
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 347 at risk

Adverse event: Testicular atrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 347 at risk

Adverse event: Brief resolved unexplained event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 347 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 347 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 347 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 164 affected / 347 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 109 affected / 347 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 200 affected / 347 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 100 affected / 347 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 128 affected / 347 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 347 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 347 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 347 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 175 affected / 347 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 241 affected / 347 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 301 affected / 347 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 347 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 347 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 347 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 347 at risk

Adverse event: Haemophilus bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 347 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 347 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 347 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 347 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 347 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 347 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 347 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 153 affected / 347 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 113 affected / 347 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 162 affected / 347 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 91 affected / 347 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 141 affected / 347 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 347 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 347 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 347 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 154 affected / 347 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 233 affected / 347 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 294 affected / 347 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 347 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 347 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 347 at risk