Study: NCT00255047

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 538 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 538 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 538 at risk

Adverse event: Kawasaki´s disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 538 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 538 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 538 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 538 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 538 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 538 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 538 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 538 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 538 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 538 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 538 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 143 affected / 538 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 538 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 538 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 538 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 90 affected / 532 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 49 affected / 532 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 342 affected / 532 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 219 affected / 531 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 128 affected / 532 at risk

Adverse event: Anbormal crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 287 affected / 532 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 271 affected / 532 at risk

Adverse event: Appetite Decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 214 affected / 532 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 399 affected / 532 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 535 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 535 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 535 at risk

Adverse event: Limb mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 535 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 535 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 535 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 535 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 535 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 535 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 535 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 535 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 535 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 535 at risk

Adverse event: Dyskinesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 535 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 535 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 535 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 535 at risk

Adverse event: Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 535 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 535 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 535 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 33 affected / 535 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 535 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 97 affected / 535 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 141 affected / 535 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 535 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 49 affected / 535 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 49 affected / 535 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 65 affected / 533 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 50 affected / 533 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 310 affected / 533 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 199 affected / 533 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 119 affected / 533 at risk

Adverse event: Anbormal crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 282 affected / 533 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 275 affected / 533 at risk

Adverse event: Appetite Decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 191 affected / 533 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 394 affected / 533 at risk

Adverse event: Congenital aortic anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 546 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 546 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 546 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 546 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 546 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 546 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 546 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 546 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 546 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 546 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 546 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 546 at risk

Adverse event: Hypotonic-hyporesponsive episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 546 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 546 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 546 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 546 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 546 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 546 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 93 affected / 546 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 134 affected / 546 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 546 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 546 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 50 affected / 546 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 64 affected / 538 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 43 affected / 538 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 301 affected / 538 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 221 affected / 537 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 131 affected / 538 at risk

Adverse event: Anbormal crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 275 affected / 539 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 262 affected / 538 at risk

Adverse event: Appetite Decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 192 affected / 538 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 421 affected / 539 at risk

Adverse event: Hepatic arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 548 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 548 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 548 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 548 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 548 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 548 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 548 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 548 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 548 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 548 at risk

Adverse event: Laryngeal stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 548 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 548 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 548 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 548 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 548 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 141 affected / 548 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 548 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 44 affected / 548 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 548 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 66 affected / 543 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 49 affected / 543 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 310 affected / 543 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 208 affected / 543 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 119 affected / 543 at risk

Adverse event: Anbormal crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 285 affected / 543 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 239 affected / 543 at risk

Adverse event: Appetite Decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 174 affected / 543 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 414 affected / 543 at risk