Study: NCT00313911

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1423 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Inguinal hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Biliary cyst
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1423 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1423 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 1423 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 1423 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1423 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1423 at risk

Adverse event: Lymphangitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1423 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1423 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1423 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1423 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1423 at risk

Adverse event: Pyoderma
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1423 at risk

Adverse event: Pyoderma streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1423 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1423 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1423 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1423 at risk

Adverse event: Hypotonic Hyporesponsive Episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1423 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Foreign body aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1423 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 131 affected / 1411 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 264 affected / 1411 at risk

Adverse event: Solicited Vomiting Post-dose 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 230 affected / 1410 at risk

Adverse event: Solicited Injection site Erythema Post-dose 3
Serious: no
Organ System: General disorders
Frequency: 587 affected / 1410 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 39 affected / 1411 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 81 affected / 1411 at risk

Adverse event: Solicited Injection Site Pain Post-dose 1
Serious: no
Organ System: General disorders
Frequency: 831 affected / 1410 at risk

Adverse event: Solicited Injection Site Swelling Post-dose 3
Serious: no
Organ System: General disorders
Frequency: 400 affected / 1408 at risk

Adverse event: Solicited Irritability post-dose 1
Serious: no
Organ System: General disorders
Frequency: 945 affected / 1410 at risk

Adverse event: Solicited Pyrexia Post-dose 2
Serious: no
Organ System: General disorders
Frequency: 675 affected / 1411 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 101 affected / 1411 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 742 affected / 1411 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 395 affected / 1411 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 136 affected / 1411 at risk

Adverse event: Solicited Anorexia Post-dose 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 388 affected / 1410 at risk

Adverse event: Solicited Somnolence Post-dose 1
Serious: no
Organ System: Nervous system disorders
Frequency: 635 affected / 1410 at risk

Adverse event: Solicited Crying Post-dose 1
Serious: no
Organ System: Psychiatric disorders
Frequency: 800 affected / 1411 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 163 affected / 1411 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 75 affected / 1411 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 160 affected / 1411 at risk

Adverse event: Cardio Respiratory Distress
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 710 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 710 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 710 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 710 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 710 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 710 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 710 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 710 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 710 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 710 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 710 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 710 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 710 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 710 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 710 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 710 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 710 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 710 at risk

Adverse event: Obstructive airways disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 710 at risk

Adverse event: Purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 710 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 703 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 123 affected / 703 at risk

Adverse event: Solicited Vomiting Post-dose 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 120 affected / 703 at risk

Adverse event: Solicited Injection site Erythema Post-dose 3
Serious: no
Organ System: General disorders
Frequency: 340 affected / 703 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 63 affected / 703 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 79 affected / 703 at risk

Adverse event: Solicited Injection Site Pain Post-dose 1
Serious: no
Organ System: General disorders
Frequency: 574 affected / 703 at risk

Adverse event: Solicited Injection Site Swelling Post-dose 3
Serious: no
Organ System: General disorders
Frequency: 323 affected / 703 at risk

Adverse event: Solicited Irritability post-dose 1
Serious: no
Organ System: General disorders
Frequency: 576 affected / 703 at risk

Adverse event: Solicited Pyrexia Post-dose 2
Serious: no
Organ System: General disorders
Frequency: 457 affected / 703 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 703 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 353 affected / 703 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 161 affected / 703 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 703 at risk

Adverse event: Solicited Anorexia Post-dose 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 278 affected / 703 at risk

Adverse event: Solicited Somnolence Post-dose 1
Serious: no
Organ System: Nervous system disorders
Frequency: 375 affected / 703 at risk

Adverse event: Solicited Crying Post-dose 1
Serious: no
Organ System: Psychiatric disorders
Frequency: 564 affected / 703 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 703 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 703 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 54 affected / 703 at risk