Study: NCT00985751

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

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

Adverse event: Redness Primary
Serious: no
Organ System: General disorders
Frequency: 24 affected / 51 at risk

Adverse event: Swelling Primary
Serious: no
Organ System: General disorders
Frequency: 17 affected / 51 at risk

Adverse event: Pain Booster
Serious: no
Organ System: General disorders
Frequency: 18 affected / 51 at risk

Adverse event: Redness Booster
Serious: no
Organ System: General disorders
Frequency: 19 affected / 51 at risk

Adverse event: Swelling Booster
Serious: no
Organ System: General disorders
Frequency: 11 affected / 51 at risk

Adverse event: Drowsiness Primary
Serious: no
Organ System: General disorders
Frequency: 25 affected / 51 at risk

Adverse event: Irritability Primary
Serious: no
Organ System: General disorders
Frequency: 26 affected / 51 at risk

Adverse event: Loss of appetite Primary
Serious: no
Organ System: General disorders
Frequency: 19 affected / 51 at risk

Adverse event: Temperature/Rectally Primary
Serious: no
Organ System: General disorders
Frequency: 13 affected / 51 at risk

Adverse event: Drowsiness Booster
Serious: no
Organ System: General disorders
Frequency: 13 affected / 51 at risk

Adverse event: Irritability Booster
Serious: no
Organ System: General disorders
Frequency: 15 affected / 51 at risk

Adverse event: Loss of appetite Booster
Serious: no
Organ System: General disorders
Frequency: 6 affected / 51 at risk

Adverse event: Temperature/Rectally Booster
Serious: no
Organ System: General disorders
Frequency: 8 affected / 51 at risk

Adverse event: Nasopharyngitis Primary
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

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

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

Adverse event: Rhinitis Booster
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

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

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

Adverse event: Ear haemorrhage
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 52 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Pharyngo-tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Pain Primary
Serious: no
Organ System: General disorders
Frequency: 28 affected / 52 at risk

Adverse event: Redness Primary
Serious: no
Organ System: General disorders
Frequency: 30 affected / 52 at risk

Adverse event: Swelling Primary
Serious: no
Organ System: General disorders
Frequency: 11 affected / 52 at risk

Adverse event: Pain Booster
Serious: no
Organ System: General disorders
Frequency: 22 affected / 52 at risk

Adverse event: Redness Booster
Serious: no
Organ System: General disorders
Frequency: 20 affected / 52 at risk

Adverse event: Swelling Booster
Serious: no
Organ System: General disorders
Frequency: 8 affected / 52 at risk

Adverse event: Drowsiness Primary
Serious: no
Organ System: General disorders
Frequency: 21 affected / 52 at risk

Adverse event: Irritability Primary
Serious: no
Organ System: General disorders
Frequency: 23 affected / 52 at risk

Adverse event: Loss of appetite Primary
Serious: no
Organ System: General disorders
Frequency: 15 affected / 52 at risk

Adverse event: Temperature/Rectally Primary
Serious: no
Organ System: General disorders
Frequency: 16 affected / 52 at risk

Adverse event: Drowsiness Booster
Serious: no
Organ System: General disorders
Frequency: 13 affected / 52 at risk

Adverse event: Irritability Booster
Serious: no
Organ System: General disorders
Frequency: 17 affected / 52 at risk

Adverse event: Loss of appetite Booster
Serious: no
Organ System: General disorders
Frequency: 10 affected / 52 at risk

Adverse event: Temperature/Rectally Booster
Serious: no
Organ System: General disorders
Frequency: 10 affected / 52 at risk

Adverse event: Nasopharyngitis Primary
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 52 at risk

Adverse event: Nasopharyngitis Booster
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Rhinitis Primary
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Rhinitis Booster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 52 at risk

Adverse event: Pain Primary
Serious: no
Organ System: General disorders
Frequency: 34 affected / 52 at risk

Adverse event: Redness Primary
Serious: no
Organ System: General disorders
Frequency: 36 affected / 52 at risk

Adverse event: Swelling Primary
Serious: no
Organ System: General disorders
Frequency: 25 affected / 52 at risk

Adverse event: Pain Booster
Serious: no
Organ System: General disorders
Frequency: 32 affected / 52 at risk

Adverse event: Redness Booster
Serious: no
Organ System: General disorders
Frequency: 28 affected / 52 at risk

Adverse event: Swelling Booster
Serious: no
Organ System: General disorders
Frequency: 18 affected / 52 at risk

Adverse event: Drowsiness Primary
Serious: no
Organ System: General disorders
Frequency: 34 affected / 52 at risk

Adverse event: Irritability Primary
Serious: no
Organ System: General disorders
Frequency: 35 affected / 52 at risk

Adverse event: Loss of appetite Primary
Serious: no
Organ System: General disorders
Frequency: 20 affected / 52 at risk

Adverse event: Temperature/Rectally Primary
Serious: no
Organ System: General disorders
Frequency: 18 affected / 52 at risk

Adverse event: Drowsiness Booster
Serious: no
Organ System: General disorders
Frequency: 18 affected / 52 at risk

Adverse event: Irritability Booster
Serious: no
Organ System: General disorders
Frequency: 26 affected / 52 at risk

Adverse event: Loss of appetite Booster
Serious: no
Organ System: General disorders
Frequency: 13 affected / 52 at risk

Adverse event: Temperature/Rectally Booster
Serious: no
Organ System: General disorders
Frequency: 10 affected / 52 at risk

Adverse event: Nasopharyngitis Primary
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 52 at risk

Adverse event: Nasopharyngitis Booster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Rhinitis Primary
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: Rhinitis Booster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pain Primary
Serious: no
Organ System: General disorders
Frequency: 33 affected / 51 at risk

Adverse event: Redness Primary
Serious: no
Organ System: General disorders
Frequency: 33 affected / 51 at risk

Adverse event: Swelling Primary
Serious: no
Organ System: General disorders
Frequency: 21 affected / 51 at risk

Adverse event: Pain Booster
Serious: no
Organ System: General disorders
Frequency: 26 affected / 51 at risk

Adverse event: Redness Booster
Serious: no
Organ System: General disorders
Frequency: 22 affected / 51 at risk

Adverse event: Swelling Booster
Serious: no
Organ System: General disorders
Frequency: 15 affected / 51 at risk

Adverse event: Drowsiness Primary
Serious: no
Organ System: General disorders
Frequency: 28 affected / 51 at risk

Adverse event: Irritability Primary
Serious: no
Organ System: General disorders
Frequency: 36 affected / 51 at risk

Adverse event: Loss of appetite Primary
Serious: no
Organ System: General disorders
Frequency: 19 affected / 51 at risk

Adverse event: Temperature/Rectally Primary
Serious: no
Organ System: General disorders
Frequency: 18 affected / 51 at risk

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

Adverse event: Irritability Booster
Serious: no
Organ System: General disorders
Frequency: 17 affected / 51 at risk

Adverse event: Loss of appetite Booster
Serious: no
Organ System: General disorders
Frequency: 15 affected / 51 at risk

Adverse event: Temperature/Rectally Booster
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk

Adverse event: Nasopharyngitis Primary
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

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

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

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

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

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

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

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 51 at risk

Adverse event: Pain Primary
Serious: no
Organ System: General disorders
Frequency: 34 affected / 51 at risk

Adverse event: Redness Primary
Serious: no
Organ System: General disorders
Frequency: 30 affected / 51 at risk

Adverse event: Swelling Primary
Serious: no
Organ System: General disorders
Frequency: 26 affected / 51 at risk

Adverse event: Pain Booster
Serious: no
Organ System: General disorders
Frequency: 25 affected / 51 at risk

Adverse event: Redness Booster
Serious: no
Organ System: General disorders
Frequency: 21 affected / 51 at risk

Adverse event: Swelling Booster
Serious: no
Organ System: General disorders
Frequency: 13 affected / 51 at risk

Adverse event: Drowsiness Primary
Serious: no
Organ System: General disorders
Frequency: 35 affected / 51 at risk

Adverse event: Irritability Primary
Serious: no
Organ System: General disorders
Frequency: 35 affected / 51 at risk

Adverse event: Loss of appetite Primary
Serious: no
Organ System: General disorders
Frequency: 23 affected / 51 at risk

Adverse event: Temperature/Rectally Primary
Serious: no
Organ System: General disorders
Frequency: 17 affected / 51 at risk

Adverse event: Drowsiness Booster
Serious: no
Organ System: General disorders
Frequency: 17 affected / 51 at risk

Adverse event: Irritability Booster
Serious: no
Organ System: General disorders
Frequency: 19 affected / 51 at risk

Adverse event: Loss of appetite Booster
Serious: no
Organ System: General disorders
Frequency: 8 affected / 51 at risk

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

Adverse event: Nasopharyngitis Primary
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 51 at risk

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

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

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

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

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

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

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