Study: NCT00574795

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 193 at risk

Adverse event: Pulmonary valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 193 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 193 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 193 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 193 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 193 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 193 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 193 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 193 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 193 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 163 affected / 193 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 121 affected / 193 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 108 affected / 193 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 93 affected / 193 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 193 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 16 affected / 193 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 3 affected / 193 at risk

Adverse event: Injection site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 193 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 193 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 193 at risk

Adverse event: Vaccination site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 193 at risk

Adverse event: Vessel puncture site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 193 at risk

Adverse event: Liver disorder
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 193 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 193 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 193 at risk

Adverse event: Solvent sensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 193 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 77 affected / 193 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 193 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 193 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 193 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 193 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 193 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 193 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 193 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 193 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 193 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 193 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 193 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 193 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 193 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 193 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 193 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 193 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 193 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Gastroenteritis rotavirus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Enterocolitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Enterovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Omphalitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Pertussis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Rotavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Viral diarrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 193 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 193 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 193 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 193 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 193 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 193 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 193 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 193 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 193 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 193 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 193 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 193 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 101 affected / 193 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 193 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 66 affected / 193 at risk

Adverse event: Head banging
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 193 at risk

Adverse event: Vesicoureteric reflux
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 193 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 193 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 193 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 193 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 193 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 193 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 193 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 193 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 193 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 193 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 193 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 193 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 193 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 193 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 193 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 193 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 193 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 193 at risk

Adverse event: Asteatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 22 affected / 165 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 31 affected / 156 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 21 affected / 147 at risk

Adverse event: Tenderness (Significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 1 affected / 160 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 83 affected / 176 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 93 affected / 173 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 89 affected / 165 at risk

Adverse event: Induration(Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 80 affected / 174 at risk

Adverse event: Induration(Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 84 affected / 171 at risk

Adverse event: Induration(Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 82 affected / 163 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 24 affected / 167 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 47 affected / 164 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 44 affected / 150 at risk

Adverse event: Induration (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 2 affected / 153 at risk

Adverse event: Induration (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 1 affected / 143 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 138 affected / 186 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 134 affected / 180 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 116 affected / 171 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 125 affected / 183 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 116 affected / 179 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 90 affected / 162 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 42 affected / 170 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 73 affected / 168 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 61 affected / 157 at risk

Adverse event: Erythema (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 2 Infant Series
Frequency: 2 affected / 153 at risk

Adverse event: Erythema (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 3 Infant Series
Frequency: 1 affected / 143 at risk

Adverse event: Any fever (≥37.5°C)
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 56 affected / 170 at risk

Adverse event: Any fever (≥37.5°C)
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 54 affected / 163 at risk

Adverse event: Any fever (≥37.5°C)
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 62 affected / 154 at risk

Adverse event: Fever ≥38°C but ≤39°C (mild)
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 11 affected / 163 at risk

Adverse event: Fever ≥38°C but ≤39°C (mild)
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 19 affected / 156 at risk

Adverse event: Fever ≥38°C but ≤39°C (mild)
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 15 affected / 146 at risk

Adverse event: Fever >39°C but ≤40°C (moderate)
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 2 affected / 161 at risk

Adverse event: Fever >39°C but ≤40°C (moderate)
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 4 affected / 153 at risk

Adverse event: Fever >39°C but ≤40°C (moderate)
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 4 affected / 143 at risk

Adverse event: Fever >40°C (severe)
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 1 affected / 152 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 19 affected / 163 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 26 affected / 158 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 14 affected / 144 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 52 affected / 170 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 60 affected / 166 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 35 affected / 149 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 71 affected / 175 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 47 affected / 160 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 34 affected / 153 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 36 affected / 169 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 37 affected / 160 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 23 affected / 145 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 2 affected / 160 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Dose 2 Infant Series
Frequency: 2 affected / 152 at risk

Adverse event: Hives (urticaria)
Serious: no
Organ System: General disorders
Notes: Dose 3 Infant Series
Frequency: 1 affected / 143 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 193 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 193 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Cryptorchism
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 193 at risk

Adverse event: Pectus excavatum
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 193 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 193 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 193 at risk

Adverse event: Lymphangioma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 193 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 193 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 193 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 185 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 185 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 185 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 185 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 185 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 115 affected / 185 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 94 affected / 185 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 80 affected / 185 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 38 affected / 185 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 185 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 185 at risk

Adverse event: Injection site eczema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 185 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 185 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 185 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 185 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 185 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 185 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 185 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 185 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 185 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 185 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Adenovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 185 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 185 at risk

Adverse event: Adenoviral upper respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Gastroenteritis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 185 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 185 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Mouth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 185 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 185 at risk

Adverse event: Fibroma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 185 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 185 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 185 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 185 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 185 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Fibrinous bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 185 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 185 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Eczema infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 185 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 185 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Tenderness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 26 affected / 143 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 93 affected / 163 at risk

Adverse event: Induration(Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 68 affected / 154 at risk

Adverse event: Induration (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 55 affected / 151 at risk

Adverse event: Induration (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 3 affected / 132 at risk

Adverse event: Erythema (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 113 affected / 166 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 84 affected / 156 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 63 affected / 155 at risk

Adverse event: Erythema (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 2 affected / 132 at risk

Adverse event: Any fever (≥37.5°C)
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 76 affected / 150 at risk

Adverse event: Fever ≥38°C but ≤39°C (mild)
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 28 affected / 137 at risk

Adverse event: Fever >39°C but ≤40°C (moderate)
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 7 affected / 133 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 25 affected / 138 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 37 affected / 140 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 34 affected / 139 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Dose 1 Infant Series and Toddler Dose
Frequency: 17 affected / 138 at risk