Study: NCT00289783

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 19 affected / 3136 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 18 affected / 3136 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 15 affected / 3136 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 8 affected / 3136 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 11 affected / 3136 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 8 affected / 3136 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 8 affected / 3136 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 8 affected / 3136 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 8 affected / 3136 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 4 affected / 3136 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 4 affected / 3136 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 5 affected / 3136 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 5 affected / 3136 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 3 affected / 3136 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 3 affected / 3136 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 3 affected / 3136 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 4 affected / 3136 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Brief resolved unexplained event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Viral skin infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 3136 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Acarodermatitis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Cerebellar ataxia
Serious: yes
Organ System: Nervous system disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Child maltreatment syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Coarctation of the aorta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Dacryostenosis acquired
Serious: yes
Organ System: Eye disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Group B streptococcus neonatal sepsis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: HIV infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Infantile spasms
Serious: yes
Organ System: Nervous system disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Irritability
Serious: yes
Organ System: General disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Lymphoid tissue hyperplasia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Neuroblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Tuberous sclerosis complex
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Vulval abscess
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 3136 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 5 affected / 2769 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 4 affected / 2769 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 3 affected / 2769 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 5 affected / 2769 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 4 affected / 2769 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 2 affected / 2769 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 2 affected / 2769 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 2 affected / 2769 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Burns first degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Cellulitis of male external genital organ
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Rash papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 2769 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 524 affected / 3136 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 335 affected / 3136 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 197 affected / 3136 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 176 affected / 3136 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 185 affected / 3136 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 180 affected / 3136 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 163 affected / 3136 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 146 affected / 3136 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within the 31 days (Day 0-30) after the fourth dose phase
Frequency: 176 affected / 2769 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31 days (Day 0-30) after the fourth dose phase
Frequency: 152 affected / 2769 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Within the 31 days (Day 0-30) after the fourth dose phase
Frequency: 135 affected / 2769 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31 days (Day 0-30) after the fourth dose phase
Frequency: 115 affected / 2769 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 2419 affected / 3088 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 2052 affected / 3088 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 1707 affected / 3088 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 2418 affected / 3088 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 1434 affected / 3089 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 2740 affected / 3088 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 1764 affected / 3088 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 1319 affected / 2528 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 1213 affected / 2528 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 936 affected / 2526 at risk

Adverse event: Increase in limb circumference
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 1489 affected / 2769 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 1088 affected / 2526 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 341 affected / 2527 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 1482 affected / 2526 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 825 affected / 2526 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 7 affected / 1044 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 5 affected / 1044 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 1044 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 4 affected / 1044 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 1044 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 1044 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 1044 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 4 affected / 1044 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 1044 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 3 affected / 1044 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 3 affected / 1044 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 1044 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 2 affected / 1044 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Bronchial aspiration procedure
Serious: yes
Organ System: Investigations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Gastroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Typhoid fever
Serious: yes
Organ System: Infections and infestations
Notes: From Day 0 after Dose 1 through the day preceding the fourth dose.
Frequency: 1 affected / 1044 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 4 affected / 923 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 2 affected / 923 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 2 affected / 923 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Accidental exposure to product by child
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Adenoviral upper respiratory infection
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Lymph node abscess
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From the fourth dose through the end of the 6-month safety follow-up
Frequency: 1 affected / 923 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 173 affected / 1044 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 104 affected / 1044 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 65 affected / 1044 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 73 affected / 1044 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 57 affected / 1044 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 55 affected / 1044 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 50 affected / 1044 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the 31 days (Day 0-30) after the primary vaccination course.
Frequency: 53 affected / 1044 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within the 31 days (Day 0-30) after the fourth dose phase
Frequency: 64 affected / 923 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Within the 31 days (Day 0-30) after the fourth dose phase
Frequency: 50 affected / 923 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Within the 31 days (Day 0-30) after the fourth dose phase
Frequency: 47 affected / 923 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Within the 31 days (Day 0-30) after the fourth dose phase
Frequency: 46 affected / 923 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 819 affected / 1016 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 691 affected / 1016 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 568 affected / 1016 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 804 affected / 1015 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 463 affected / 1015 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 926 affected / 1015 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post primary vaccination course
Frequency: 609 affected / 1015 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 494 affected / 832 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 463 affected / 833 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 334 affected / 832 at risk

Adverse event: Increase in limb circumference
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 503 affected / 923 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 381 affected / 830 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 134 affected / 831 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 534 affected / 830 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 4-day (Day 0-3) post-vaccination period following the fourth dose
Frequency: 287 affected / 830 at risk