Study: NCT00626327

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 500 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Postoperative wound infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 500 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 125 affected / 500 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 500 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 500 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 219 affected / 500 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 128 affected / 500 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 163 affected / 500 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 273 affected / 500 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 90 affected / 500 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 92 affected / 500 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 500 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 135 affected / 500 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 219 affected / 500 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 132 affected / 500 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 500 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 76 affected / 500 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 597 at risk

Adverse event: Systemic inflamatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 597 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 597 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 597 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Toxic shock syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 597 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 597 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 597 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 114 affected / 597 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 597 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 597 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 224 affected / 597 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 102 affected / 597 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 180 affected / 597 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 299 affected / 597 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 70 affected / 597 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 597 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 597 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 109 affected / 597 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 197 affected / 597 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 105 affected / 597 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 597 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 87 affected / 597 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 500 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 500 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 500 at risk

Adverse event: Feeding disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Tethered cord syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 128 affected / 500 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 500 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 79 affected / 500 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 230 affected / 500 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 115 affected / 500 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 188 affected / 500 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 299 affected / 500 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 114 affected / 500 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 120 affected / 500 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 92 affected / 500 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 152 affected / 500 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 199 affected / 500 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 136 affected / 500 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 500 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 52 affected / 500 at risk