Study: NCT00092443

Adverse event: Perirectal abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 649 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 649 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 649 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 649 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 649 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 649 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 649 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 649 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 649 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 649 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 649 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 649 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 649 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 649 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 649 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 649 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 50 affected / 649 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 649 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 103 affected / 649 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 649 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 649 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 649 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 61 affected / 649 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 283 affected / 649 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 91 affected / 649 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 119 affected / 649 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 649 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 69 affected / 649 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 150 affected / 649 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 102 affected / 649 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 53 affected / 649 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 155 affected / 649 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 95 affected / 649 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 649 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 649 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 658 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 658 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 658 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 658 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 658 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 658 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 658 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 658 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 658 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 658 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 658 at risk

Adverse event: Spinal cord neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 658 at risk

Adverse event: Cerebral cyst
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 658 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 658 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 658 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 46 affected / 658 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 658 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 110 affected / 658 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 658 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 658 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 658 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 62 affected / 658 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 265 affected / 658 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 106 affected / 658 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 111 affected / 658 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 658 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 81 affected / 658 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 143 affected / 658 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 99 affected / 658 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 52 affected / 658 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 172 affected / 658 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 90 affected / 658 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 658 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 658 at risk