Study: NCT01193335

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: Ovarian cyst torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 100 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Infantile colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 100 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 100 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 100 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 100 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 100 at risk

Adverse event: Hypotonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Subdural hygroma
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 100 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 100 at risk

Adverse event: Tenderness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 46 affected / 94 at risk

Adverse event: Tenderness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 41 affected / 85 at risk

Adverse event: Tenderness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 32 affected / 82 at risk

Adverse event: Tenderness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 43 affected / 93 at risk

Adverse event: Tenderness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 37 affected / 85 at risk

Adverse event: Tenderness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 29 affected / 81 at risk

Adverse event: Tenderness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 16 affected / 90 at risk

Adverse event: Tenderness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 11 affected / 77 at risk

Adverse event: Tenderness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 7 affected / 75 at risk

Adverse event: Swelling- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 37 affected / 94 at risk

Adverse event: Swelling- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 30 affected / 84 at risk

Adverse event: Swelling- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 25 affected / 83 at risk

Adverse event: Swelling- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 34 affected / 91 at risk

Adverse event: Swelling- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 28 affected / 83 at risk

Adverse event: Swelling- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 22 affected / 82 at risk

Adverse event: Swelling- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 8 affected / 91 at risk

Adverse event: Swelling- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 6 affected / 75 at risk

Adverse event: Swelling- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 4 affected / 75 at risk

Adverse event: Redness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 31 affected / 92 at risk

Adverse event: Redness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 23 affected / 82 at risk

Adverse event: Redness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 27 affected / 82 at risk

Adverse event: Redness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 29 affected / 90 at risk

Adverse event: Redness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 23 affected / 82 at risk

Adverse event: Redness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 27 affected / 82 at risk

Adverse event: Redness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 3 affected / 88 at risk

Adverse event: Redness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 2 affected / 73 at risk

Adverse event: Redness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 1 affected / 74 at risk

Adverse event: Fever >=38 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 10 affected / 86 at risk

Adverse event: Fever >=38 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 22 affected / 79 at risk

Adverse event: Fever >=38 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 22 affected / 79 at risk

Adverse event: Fever >=38 degrees C, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 9 affected / 86 at risk

Adverse event: Fever >=38 degrees C, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 22 affected / 79 at risk

Adverse event: Fever >=38 degrees C, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 21 affected / 78 at risk

Adverse event: Fever >=39 degrees C, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 1 affected / 86 at risk

Adverse event: Fever >=39 degrees C, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 1 affected / 75 at risk

Adverse event: Decreased Appetite- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 56 affected / 92 at risk

Adverse event: Decreased Appetite- Any
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 55 affected / 89 at risk

Adverse event: Decreased Appetite- Any
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 40 affected / 82 at risk

Adverse event: Decreased Appetite- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 50 affected / 91 at risk

Adverse event: Decreased Appetite- Mild
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 49 affected / 88 at risk

Adverse event: Decreased Appetite- Mild
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 30 affected / 82 at risk

Adverse event: Decreased Appetite- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 18 affected / 88 at risk

Adverse event: Decreased Appetite- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 20 affected / 79 at risk

Adverse event: Decreased Appetite- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 13 affected / 74 at risk

Adverse event: Decreased Appetite- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 1 affected / 86 at risk

Adverse event: Decreased Appetite- Severe
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 1 affected / 73 at risk

Adverse event: Decreased Appetite- Severe
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 1 affected / 74 at risk

Adverse event: Increased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 65 affected / 96 at risk

Adverse event: Increased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 63 affected / 85 at risk

Adverse event: Increased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 46 affected / 88 at risk

Adverse event: Increased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 58 affected / 96 at risk

Adverse event: Increased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 58 affected / 83 at risk

Adverse event: Increased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 43 affected / 88 at risk

Adverse event: Increased Sleep- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 26 affected / 87 at risk

Adverse event: Increased Sleep- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 27 affected / 78 at risk

Adverse event: Increased Sleep- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 13 affected / 77 at risk

Adverse event: Increased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 2 affected / 86 at risk

Adverse event: Increased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 2 affected / 73 at risk

Adverse event: Increased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 1 affected / 73 at risk

Adverse event: Irritability or Decreased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 80 affected / 95 at risk

Adverse event: Irritability or Decreased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 85 affected / 95 at risk

Adverse event: Irritability or Decreased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 73 affected / 92 at risk

Adverse event: Irritability or Decreased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 72 affected / 93 at risk

Adverse event: Irritability or Decreased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 73 affected / 90 at risk

Adverse event: Irritability or Decreased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 65 affected / 90 at risk

Adverse event: Irritability or Decreased Sleep-Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 40 affected / 92 at risk

Adverse event: Irritability or Decreased Sleep-Moderate
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 55 affected / 85 at risk

Adverse event: Irritability or Decreased Sleep-Moderate
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 27 affected / 80 at risk

Adverse event: Irritability or Decreased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 7 affected / 86 at risk

Adverse event: Irritability or Decreased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 13 affected / 74 at risk

Adverse event: Irritability or Decreased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 5 affected / 74 at risk

Adverse event: Use of Antipyretic Medication
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 22 affected / 90 at risk

Adverse event: Use of Antipyretic Medication
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 41 affected / 84 at risk

Adverse event: Use of Antipyretic Medication
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 34 affected / 84 at risk

Adverse event: Adenoviral upper respiratory infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Craniotabes
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hydrocele
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 100 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 100 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 100 at risk

Adverse event: Respiratory tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 100 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 100 at risk

Adverse event: Allergic respiratory disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Tenderness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 37 affected / 88 at risk

Adverse event: Tenderness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 34 affected / 88 at risk

Adverse event: Tenderness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 24 affected / 84 at risk

Adverse event: Tenderness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 28 affected / 88 at risk

Adverse event: Tenderness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 26 affected / 84 at risk

Adverse event: Tenderness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 22 affected / 84 at risk

Adverse event: Tenderness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 14 affected / 85 at risk

Adverse event: Tenderness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 13 affected / 83 at risk

Adverse event: Tenderness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 4 affected / 78 at risk

Adverse event: Tenderness- Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 1 affected / 77 at risk

Adverse event: Swelling- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 26 affected / 89 at risk

Adverse event: Swelling- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 35 affected / 82 at risk

Adverse event: Swelling- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 35 affected / 85 at risk

Adverse event: Swelling- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 25 affected / 89 at risk

Adverse event: Swelling- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 35 affected / 82 at risk

Adverse event: Swelling- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 35 affected / 85 at risk

Adverse event: Swelling- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 7 affected / 85 at risk

Adverse event: Swelling- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 2 affected / 76 at risk

Adverse event: Swelling- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 4 affected / 79 at risk

Adverse event: Redness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 26 affected / 87 at risk

Adverse event: Redness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 33 affected / 82 at risk

Adverse event: Redness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 40 affected / 87 at risk

Adverse event: Redness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 25 affected / 87 at risk

Adverse event: Redness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 31 affected / 82 at risk

Adverse event: Redness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 40 affected / 87 at risk

Adverse event: Redness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 4 affected / 85 at risk

Adverse event: Redness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 2 affected / 76 at risk

Adverse event: Redness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 3 affected / 79 at risk

Adverse event: Fever >=38 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 12 affected / 88 at risk

Adverse event: Fever >=38 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 25 affected / 79 at risk

Adverse event: Fever >=38 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 25 affected / 81 at risk

Adverse event: Fever >=38 degrees C, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 12 affected / 88 at risk

Adverse event: Fever >=38 degrees C, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 24 affected / 79 at risk

Adverse event: Fever >=38 degrees C, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 25 affected / 81 at risk

Adverse event: Fever >=39 degrees C, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 1 affected / 76 at risk

Adverse event: Fever >=39 degrees C, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 2 affected / 78 at risk

Adverse event: Decreased Appetite- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 37 affected / 89 at risk

Adverse event: Decreased Appetite- Any
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 39 affected / 84 at risk

Adverse event: Decreased Appetite- Any
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 40 affected / 84 at risk

Adverse event: Decreased Appetite- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 31 affected / 88 at risk

Adverse event: Decreased Appetite- Mild
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 35 affected / 84 at risk

Adverse event: Decreased Appetite- Mild
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 39 affected / 84 at risk

Adverse event: Decreased Appetite- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 15 affected / 87 at risk

Adverse event: Decreased Appetite- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 15 affected / 78 at risk

Adverse event: Decreased Appetite- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 13 affected / 79 at risk

Adverse event: Decreased Appetite- Severe
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 1 affected / 77 at risk

Adverse event: Increased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 66 affected / 95 at risk

Adverse event: Increased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 57 affected / 89 at risk

Adverse event: Increased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 51 affected / 88 at risk

Adverse event: Increased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 57 affected / 93 at risk

Adverse event: Increased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 52 affected / 88 at risk

Adverse event: Increased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 45 affected / 87 at risk

Adverse event: Increased Sleep- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 27 affected / 88 at risk

Adverse event: Increased Sleep- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 23 affected / 78 at risk

Adverse event: Increased Sleep- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 16 affected / 80 at risk

Adverse event: Increased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 2 affected / 85 at risk

Adverse event: Increased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 1 affected / 76 at risk

Adverse event: Increased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 1 affected / 77 at risk

Adverse event: Irritability or Decreased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 80 affected / 97 at risk

Adverse event: Irritability or Decreased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 74 affected / 95 at risk

Adverse event: Irritability or Decreased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 77 affected / 95 at risk

Adverse event: Irritability or Decreased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 66 affected / 95 at risk

Adverse event: Irritability or Decreased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 66 affected / 92 at risk

Adverse event: Irritability or Decreased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 68 affected / 91 at risk

Adverse event: Irritability or Decreased Sleep-Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 43 affected / 91 at risk

Adverse event: Irritability or Decreased Sleep-Moderate
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 38 affected / 86 at risk

Adverse event: Irritability or Decreased Sleep-Moderate
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 31 affected / 87 at risk

Adverse event: Irritability or Decreased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 5 affected / 85 at risk

Adverse event: Irritability or Decreased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 2 affected / 76 at risk

Adverse event: Irritability or Decreased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 5 affected / 78 at risk

Adverse event: Use of Antipyretic Medication
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 22 affected / 90 at risk

Adverse event: Use of Antipyretic Medication
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 38 affected / 83 at risk

Adverse event: Use of Antipyretic Medication
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 31 affected / 81 at risk

Adverse event: Inguinal hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Beckwith-Wiedemann syndrome
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 100 at risk

Adverse event: Human herpesvirus 6 infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Viral rash
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 100 at risk

Adverse event: Allergy to arthropod sting
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 99 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 99 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Tenderness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 60 affected / 86 at risk

Adverse event: Tenderness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 57 affected / 86 at risk

Adverse event: Tenderness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 16 affected / 77 at risk

Adverse event: Tenderness- Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 2 affected / 74 at risk

Adverse event: Swelling- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 35 affected / 81 at risk

Adverse event: Swelling- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 31 affected / 80 at risk

Adverse event: Swelling- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 10 affected / 76 at risk

Adverse event: Swelling- Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 1 affected / 74 at risk

Adverse event: Redness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 44 affected / 85 at risk

Adverse event: Redness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 44 affected / 85 at risk

Adverse event: Redness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 5 affected / 75 at risk

Adverse event: Fever >=38 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 23 affected / 80 at risk

Adverse event: Fever >=38 degrees C, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 22 affected / 80 at risk

Adverse event: Fever >=39 degrees C, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 1 affected / 74 at risk

Adverse event: Decreased Appetite- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 50 affected / 87 at risk

Adverse event: Decreased Appetite- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 43 affected / 86 at risk

Adverse event: Decreased Appetite- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 20 affected / 78 at risk

Adverse event: Decreased Appetite- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 1 affected / 75 at risk

Adverse event: Increased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 48 affected / 83 at risk

Adverse event: Increased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 44 affected / 82 at risk

Adverse event: Increased Sleep- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 14 affected / 76 at risk

Adverse event: Irritability or Decreased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 76 affected / 90 at risk

Adverse event: Irritability or Decreased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 67 affected / 90 at risk

Adverse event: Irritability or Decreased Sleep-Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 35 affected / 78 at risk

Adverse event: Irritability or Decreased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 5 affected / 76 at risk

Adverse event: Use of Antipyretic Medication
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 40 affected / 82 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 97 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 97 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 97 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Tenderness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 47 affected / 85 at risk

Adverse event: Tenderness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 44 affected / 85 at risk

Adverse event: Tenderness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 8 affected / 70 at risk

Adverse event: Swelling- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 28 affected / 80 at risk

Adverse event: Swelling- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 26 affected / 79 at risk

Adverse event: Swelling- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 7 affected / 74 at risk

Adverse event: Redness- Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 41 affected / 83 at risk

Adverse event: Redness- Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 40 affected / 83 at risk

Adverse event: Redness- Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 8 affected / 75 at risk

Adverse event: Fever >=38 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 34 affected / 78 at risk

Adverse event: Fever >=38 degrees C, =<39 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 33 affected / 77 at risk

Adverse event: Fever >=39 degrees C, =<40 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 3 affected / 71 at risk

Adverse event: Fever >40 degrees C
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 1 affected / 70 at risk

Adverse event: Decreased Appetite- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 52 affected / 86 at risk

Adverse event: Decreased Appetite- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 47 affected / 84 at risk

Adverse event: Decreased Appetite- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 17 affected / 73 at risk

Adverse event: Decreased Appetite- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 1 affected / 69 at risk

Adverse event: Increased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 56 affected / 86 at risk

Adverse event: Increased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 50 affected / 84 at risk

Adverse event: Increased Sleep- Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 18 affected / 74 at risk

Adverse event: Increased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 2 affected / 70 at risk

Adverse event: Irritability or Decreased Sleep- Any
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 73 affected / 91 at risk

Adverse event: Irritability or Decreased Sleep- Mild
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 68 affected / 89 at risk

Adverse event: Irritability or Decreased Sleep-Moderate
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 36 affected / 80 at risk

Adverse event: Irritability or Decreased Sleep- Severe
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 3 affected / 69 at risk

Adverse event: Use of Antipyretic Medication
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 40 affected / 79 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 99 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Pneumonia mycoplasmal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: CSF shunt operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 97 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cerebral palsy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 88 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Autism spectrum disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Arthritis reactive
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 88 at risk