Study: NCT01659996

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 421 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 421 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 421 at risk

Adverse event: Penile abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 421 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 421 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 421 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 421 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 421 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 421 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 421 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 421 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 219 affected / 420 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 106 affected / 420 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 95 affected / 420 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 71 affected / 421 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 222 affected / 420 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 209 affected / 420 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 182 affected / 420 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 421 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 421 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 42 affected / 421 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 421 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 421 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 421 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 421 at risk

Adverse event: Injection-site Swelling
Serious: no
Organ System: General disorders
Frequency: 63 affected / 420 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 296 affected / 420 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 395 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 395 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 395 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 395 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 395 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 395 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 395 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 395 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 242 affected / 393 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 152 affected / 393 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 393 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 85 affected / 394 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 205 affected / 393 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 206 affected / 393 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 188 affected / 393 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 395 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 395 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 395 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 395 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 44 affected / 395 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 395 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 395 at risk

Adverse event: Injection-site Swelling
Serious: no
Organ System: General disorders
Frequency: 91 affected / 393 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 284 affected / 393 at risk

Adverse event: Neutropenic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 472 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 238 affected / 463 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 144 affected / 463 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 472 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 57 affected / 463 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 181 affected / 463 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 139 affected / 463 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 163 affected / 463 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 472 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 472 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 472 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 472 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 472 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 472 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 472 at risk

Adverse event: Injection-site Swelling
Serious: no
Organ System: General disorders
Frequency: 99 affected / 463 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 271 affected / 463 at risk