Study: NCT01240746

Adverse event: Drowning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 734 at risk

Adverse event: Respiratory syncytial vrus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 734 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 734 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 734 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 734 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 333 affected / 540 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 161 affected / 734 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 99 affected / 539 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 180 affected / 539 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 174 affected / 539 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 77 affected / 159 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 246 affected / 699 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 75 affected / 695 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 159 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 53 affected / 159 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 159 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 58 affected / 159 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 84 affected / 159 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 734 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 734 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 44 affected / 734 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 734 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 95 affected / 734 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 734 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 721 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 721 at risk

Adverse event: Mycoplasma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 721 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 721 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 721 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 721 at risk

Adverse event: Respiratory syncytial vrus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 721 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 721 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 721 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 721 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 721 at risk

Adverse event: Bronchial hrperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 721 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 329 affected / 547 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 154 affected / 692 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 115 affected / 546 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 181 affected / 546 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 190 affected / 546 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 72 affected / 145 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 238 affected / 692 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 68 affected / 689 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 144 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 144 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 144 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 144 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 77 affected / 144 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 721 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 721 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 65 affected / 721 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 721 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 89 affected / 721 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 721 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2892 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2892 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2892 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2892 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2892 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2892 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2892 at risk

Adverse event: Respiratory syncytial vrus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2892 at risk

Adverse event: Respiratory syncytial vrus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2892 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2892 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2892 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2892 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2892 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2892 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2892 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2892 at risk

Adverse event: Astrocytoma, low grade
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2892 at risk

Adverse event: Autism spectrum disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2892 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 2892 at risk

Adverse event: Seizure anoxic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2892 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 2892 at risk

Adverse event: Bronchial hrperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2892 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2892 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2892 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1358 affected / 2113 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 643 affected / 2742 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 414 affected / 2110 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 705 affected / 2110 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 753 affected / 2110 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 340 affected / 628 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 972 affected / 2742 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 276 affected / 2739 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 93 affected / 628 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 203 affected / 628 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 237 affected / 628 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 259 affected / 628 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 339 affected / 628 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 135 affected / 2892 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 193 affected / 2892 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 188 affected / 2892 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 184 affected / 2892 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 341 affected / 2892 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 167 affected / 2892 at risk