Study: NCT00345683

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 28 affected / 3010 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 6 affected / 3010 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 8 affected / 3010 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 3010 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 3 affected / 3010 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 6 affected / 3010 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 3010 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 3010 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 3010 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 3 affected / 3010 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 3010 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 3010 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 3010 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 3010 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Folliculitis
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Lymphangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 3010 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 7 affected / 1010 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 3 affected / 1010 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 1010 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 1010 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 1010 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 1010 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 2 affected / 1010 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 1010 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 1010 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 1010 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 1010 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Notes: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Frequency: 1 affected / 1010 at risk