Study: NCT00502593

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 51 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 51 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 9 affected / 51 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 51 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 51 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 51 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 10 affected / 51 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 7 affected / 51 at risk

Adverse event: Fever (axillary temperature >=37.5°C)
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 8 affected / 51 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 9 affected / 51 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 12 affected / 51 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 51 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years
Frequency: 4 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years
Frequency: 7 affected / 51 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 18 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Myringitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 18 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 18 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 18 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 18 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 12 affected / 51 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 44 affected / 51 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 12 affected / 51 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 14 affected / 51 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 6 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 7 affected / 51 at risk

Adverse event: Fever (axillary temperature >= 37.5°C)
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 7 affected / 51 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 9 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 20 affected / 51 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years
Frequency: 10 affected / 51 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 3 affected / 51 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 3 affected / 51 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 18 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 18 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 18 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 18 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 3 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 1 affected / 18 at risk

Adverse event: Fever (axillary temperature >= 37.5°C)
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 3 affected / 18 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 5 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 5 affected / 18 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years
Frequency: 3 affected / 18 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 1 affected / 18 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 2 affected / 18 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: This SAE was assessed as causally related to study vaccination
Frequency: 1 affected / 51 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Notes: This SAE was assessed as causally related to study vaccination
Frequency: 1 affected / 51 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 51 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 51 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 51 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 9 affected / 51 at risk

Adverse event: Fever (axillary temperature >=37.5°C)
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 10 affected / 51 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 13 affected / 51 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 8 affected / 51 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 4 affected / 51 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years
Frequency: 1 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years
Frequency: 6 affected / 51 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 17 at risk

Adverse event: Herpangina
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Scarlet fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 17 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Bronchitis chronic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 17 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 17 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 17 at risk

Adverse event: Fever (axillary temperature >=37.5°C)
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 2 affected / 17 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 2 affected / 17 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 17 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 17 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 49 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 49 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 49 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 10 affected / 49 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 7 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 6 affected / 49 at risk

Adverse event: Fever (axillary temperature >= 37.5°C)
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 3 affected / 49 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 4 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 11 affected / 49 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years
Frequency: 11 affected / 49 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 7 affected / 49 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 3 affected / 49 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 17 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 17 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 1 affected / 17 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 5 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 2 affected / 17 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years
Frequency: 2 affected / 17 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 2 affected / 17 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 49 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 49 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 14 affected / 49 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 37 affected / 49 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 16 affected / 49 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 18 affected / 49 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 12 affected / 49 at risk

Adverse event: Fever (axillary temperature >=37.5°C)
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 18 affected / 49 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 18 affected / 49 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 15 affected / 49 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 10 affected / 49 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years
Frequency: 4 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years
Frequency: 6 affected / 49 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 17 at risk

Adverse event: Tooth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 17 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 17 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 17 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 17 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years.
Frequency: 1 affected / 17 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 3-5 years
Frequency: 1 affected / 17 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 49 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 10 affected / 49 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 44 affected / 49 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 49 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 14 affected / 49 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 9 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 11 affected / 49 at risk

Adverse event: Fever (axillary temperature >= 37.5°C)
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 18 affected / 49 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 16 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 25 affected / 49 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years
Frequency: 13 affected / 49 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 13 affected / 49 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 6 affected / 49 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fibula fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pityriasis rosea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 18 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 2 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 2 affected / 18 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 5 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 3 affected / 18 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years
Frequency: 2 affected / 18 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 3 affected / 18 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Symptom assessed in subjects aged 6-9 years.
Frequency: 1 affected / 18 at risk