Study: NCT01198756

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 932 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 932 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 932 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 932 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 637 affected / 913 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 57 affected / 913 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 64 affected / 913 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 46 affected / 185 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 59 affected / 185 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 40 affected / 185 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 15 affected / 185 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 173 affected / 727 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 80 affected / 727 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 170 affected / 727 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 103 affected / 727 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 222 affected / 727 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 55 affected / 727 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 932 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 932 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 932 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 932 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 932 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 932 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 929 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 929 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 929 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 929 at risk

Adverse event: Biliary dyskinesia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 929 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 929 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 929 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 929 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 929 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 929 at risk

Adverse event: Vitello-intestinal duct remnant
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 929 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 538 affected / 912 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 38 affected / 912 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 40 affected / 912 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 47 affected / 187 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 44 affected / 187 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 41 affected / 187 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 16 affected / 187 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 177 affected / 725 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 82 affected / 725 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 171 affected / 725 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 95 affected / 725 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 194 affected / 725 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 51 affected / 725 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 929 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 929 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 929 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 929 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 929 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 929 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 932 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 932 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 932 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 932 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 932 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 932 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 932 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 932 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 932 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 542 affected / 916 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 36 affected / 916 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 39 affected / 916 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 51 affected / 189 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 48 affected / 189 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 35 affected / 189 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 15 affected / 189 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 177 affected / 726 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 72 affected / 726 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 157 affected / 726 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 81 affected / 726 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 193 affected / 726 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group.
Frequency: 53 affected / 726 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 932 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 49 affected / 932 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 932 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 932 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 932 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 932 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 301 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 301 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 148 affected / 294 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 294 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 18 affected / 294 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 102 affected / 292 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 141 affected / 292 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 93 affected / 292 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: Assessed in subjects less than 5 years of age in all study Groups.
Frequency: 27 affected / 292 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 301 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 301 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 301 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 301 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 301 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 301 at risk