Study: NCT00452452

Adverse event: Diarrhoea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 90 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 90 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 90 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 90 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 90 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Tenderness (any)=present at site of vaccination.
Frequency: 13 affected / 86 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)
Frequency: 13 affected / 86 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (any)
Frequency: 12 affected / 79 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Tenderness (significant)=present and interfered with limb movement.
Frequency: 1 affected / 86 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)
Frequency: 3 affected / 86 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Tenderness (significant)
Frequency: 5 affected / 78 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Induration (any)=present at site of vaccination.
Frequency: 31 affected / 86 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (Any)
Frequency: 28 affected / 87 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (Any)
Frequency: 20 affected / 80 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 28 affected / 86 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (mild)
Frequency: 25 affected / 87 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (mild)
Frequency: 16 affected / 78 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 10 affected / 86 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)
Frequency: 12 affected / 86 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Induration (moderate)
Frequency: 9 affected / 80 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Erythema (any)=present at site of vaccination.
Frequency: 42 affected / 86 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)
Frequency: 40 affected / 87 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (any)
Frequency: 31 affected / 82 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Erythema (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 36 affected / 86 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (Mild)
Frequency: 35 affected / 87 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (Mild)
Frequency: 25 affected / 80 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Erythema(moderate)=2.5 cm to 7.0 cm.
Frequency: 14 affected / 86 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (Moderate)
Frequency: 8 affected / 86 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 3; Erythema (Moderate)
Frequency: 10 affected / 80 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Fever ≥38°C but ≤39°C
Frequency: 3 affected / 87 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever ≥38°C but ≤39°C
Frequency: 7 affected / 86 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever ≥38°C but ≤39°C
Frequency: 4 affected / 78 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Fever \>39°C but ≤40°C
Frequency: 1 affected / 86 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever \>39°C but ≤40°C
Frequency: 2 affected / 86 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Fever \>39°C but ≤40°C
Frequency: 1 affected / 79 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Decreased appetite
Frequency: 17 affected / 87 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite
Frequency: 15 affected / 87 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased appetite
Frequency: 14 affected / 80 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Irritability
Frequency: 21 affected / 87 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 30 affected / 87 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Irritability
Frequency: 20 affected / 81 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Increased sleep
Frequency: 8 affected / 87 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep
Frequency: 8 affected / 86 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Increased sleep
Frequency: 2 affected / 78 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Decreased sleep
Frequency: 21 affected / 87 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep
Frequency: 16 affected / 87 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 3; Decreased sleep
Frequency: 12 affected / 80 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 112 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 112 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 112 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 112 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 112 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 112 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 112 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 112 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 112 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 112 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 112 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Urological examination abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Tenderness (any)=present at site of vaccination.
Frequency: 36 affected / 108 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (any)
Frequency: 45 affected / 103 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Tenderness (significant)
Frequency: 4 affected / 98 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Induration (any)=present at site of vaccination.
Frequency: 49 affected / 110 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (Any)
Frequency: 43 affected / 105 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 40 affected / 109 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (mild)
Frequency: 38 affected / 105 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 27 affected / 109 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Induration (moderate)
Frequency: 12 affected / 99 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Erythema (any)=present at site of vaccination.
Frequency: 77 affected / 110 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (any)
Frequency: 58 affected / 106 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Erythema (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 61 affected / 110 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (Mild)
Frequency: 46 affected / 103 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Erythema(moderate)=2.5 cm to 7.0 cm.
Frequency: 42 affected / 110 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 2; Erythema (Moderate)
Frequency: 26 affected / 102 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Fever ≥38°C but ≤39°C
Frequency: 4 affected / 108 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Fever ≥38°C but ≤39°C
Frequency: 5 affected / 98 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Fever \>39°C but ≤40°C
Frequency: 1 affected / 108 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Decreased appetite
Frequency: 24 affected / 108 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased appetite
Frequency: 25 affected / 98 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Irritability
Frequency: 33 affected / 108 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Irritability
Frequency: 34 affected / 100 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Increased sleep
Frequency: 14 affected / 108 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Increased sleep
Frequency: 10 affected / 99 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Decreased sleep
Frequency: 21 affected / 108 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 2; Decreased sleep
Frequency: 20 affected / 98 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 152 at risk

Adverse event: Allergy to animal
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Allergy to arthropod sting
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 152 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 152 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 152 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 152 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 152 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 152 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 152 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 152 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 152 at risk

Adverse event: Tenderness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Tenderness (any)=present at site of vaccination.
Frequency: 63 affected / 149 at risk

Adverse event: Tenderness (significant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Tenderness (significant)=present and interfered with limb movement.
Frequency: 6 affected / 147 at risk

Adverse event: Induration (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Induration (any)=present at site of vaccination.
Frequency: 55 affected / 149 at risk

Adverse event: Induration (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 42 affected / 149 at risk

Adverse event: Induration (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Induration (moderate)=2.5 cm to 7.0 cm.
Frequency: 30 affected / 148 at risk

Adverse event: Erythema (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Erythema (any)=present at site of vaccination.
Frequency: 74 affected / 148 at risk

Adverse event: Erythema (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Erythema (mild)=0.5 centimeters (cm) to 2.0 cm.
Frequency: 55 affected / 147 at risk

Adverse event: Erythema (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Infant Series Dose 1; Erythema(moderate)=2.5 cm to 7.0 cm.
Frequency: 38 affected / 148 at risk

Adverse event: Fever ≥38°C but ≤39°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Fever ≥38°C but ≤39°C
Frequency: 1 affected / 147 at risk

Adverse event: Fever >39°C but ≤40°C
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Fever \>39°C but ≤40°C
Frequency: 1 affected / 147 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Decreased appetite
Frequency: 24 affected / 147 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Irritability
Frequency: 21 affected / 147 at risk

Adverse event: Increased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Increased sleep
Frequency: 17 affected / 147 at risk

Adverse event: Decreased sleep
Serious: no
Organ System: General disorders
Notes: Infant Series Dose 1; Decreased sleep
Frequency: 10 affected / 148 at risk