Study: NCT00345579

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 5 affected / 3278 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Haemorrhagic infarction
Serious: yes
Organ System: Vascular disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Inguinal hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Skull fractured base
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 3278 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 32 affected / 3278 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 39 affected / 3278 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 17 affected / 3278 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 5 affected / 3278 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 9 affected / 3278 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 10 affected / 3278 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 3278 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 4 affected / 3278 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 9 affected / 3278 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 3 affected / 3278 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 3278 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 3 affected / 3278 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 3 affected / 3278 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 3278 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 3278 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 3 affected / 3278 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 3278 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Nystagmus
Serious: yes
Organ System: Nervous system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 3278 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Breath holding
Serious: yes
Organ System: Psychiatric disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Child abuse
Serious: yes
Organ System: Social circumstances
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Pharyngitis streptococcal
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 3278 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Fractured skull depressed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 11 affected / 1113 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 6 affected / 1113 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 9 affected / 1113 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 5 affected / 1113 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 1113 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 1113 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 1113 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 1113 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 1113 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 1113 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 2 affected / 1113 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Nystagmus
Serious: yes
Organ System: Nervous system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Anastomotic leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Notes: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Frequency: 1 affected / 1113 at risk