Study: NCT00996307

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 162 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 162 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 162 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 162 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 162 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 162 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 162 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 58 affected / 162 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 53 affected / 162 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 162 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 162 at risk

Adverse event: Croup infections
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 162 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 162 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 162 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 162 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 162 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 162 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 162 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 162 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 162 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 162 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 162 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 162 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 47 affected / 162 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 162 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 162 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 162 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 162 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 162 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 162 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 162 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 162 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 162 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Nervous system disorders
Frequency: 60 affected / 162 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Abdominal abcess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 164 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 164 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 164 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 164 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 164 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 62 affected / 164 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 52 affected / 164 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 164 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 164 at risk

Adverse event: Croup infections
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 164 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 164 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 164 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 164 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 164 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 164 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 164 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 164 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 164 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 164 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 164 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 164 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 46 affected / 164 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 164 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 164 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 164 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 164 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 164 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 164 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 164 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 164 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 164 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 164 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 162 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 162 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 162 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 162 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 60 affected / 162 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 54 affected / 162 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 162 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 162 at risk

Adverse event: Croup infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 162 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 162 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 162 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 162 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 162 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 162 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 162 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 162 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 162 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 162 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 162 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 162 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 48 affected / 162 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 162 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 162 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 162 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 162 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 162 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 162 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 162 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 162 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 162 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Nervous system disorders
Frequency: 60 affected / 162 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 166 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 166 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 166 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Genital abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 166 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 166 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 166 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 166 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 166 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 52 affected / 166 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 53 affected / 166 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 166 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 166 at risk

Adverse event: Croup infections
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 166 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 166 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 166 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 166 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 166 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 166 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 166 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 166 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 166 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 166 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 166 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 166 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 42 affected / 166 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 166 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 166 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 166 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 166 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 166 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 166 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 166 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 166 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 166 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Nervous system disorders
Frequency: 50 affected / 166 at risk