Study: NCT00735644

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 302 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 302 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 302 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 302 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 302 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 302 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 302 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 84 affected / 302 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 58 affected / 302 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 64 affected / 302 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 22 affected / 302 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 51 affected / 302 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 302 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 58 affected / 302 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 58 affected / 302 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 82 affected / 302 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 91 affected / 302 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 299 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 299 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 299 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 299 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 299 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 299 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 299 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 299 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 299 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 78 affected / 299 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 59 affected / 299 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 63 affected / 299 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 20 affected / 299 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 62 affected / 299 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 299 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 54 affected / 299 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 299 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 71 affected / 299 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 79 affected / 299 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 297 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 297 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 297 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 297 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 297 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 297 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 297 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 297 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 67 affected / 297 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 87 affected / 297 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 21 affected / 297 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 64 affected / 297 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 297 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 50 affected / 297 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 297 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 74 affected / 297 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 79 affected / 297 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 199 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 199 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Testicular yolk sac tumour stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 199 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 199 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 199 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 199 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 199 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 59 affected / 199 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 54 affected / 199 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 199 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 48 affected / 199 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 199 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 199 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 199 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 57 affected / 199 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 65 affected / 199 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 102 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 102 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 102 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 102 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 26 affected / 102 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 102 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 102 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 102 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 102 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 102 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 102 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 102 at risk