Study: NCT00414050

Adverse event: Nutritional condition abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 430 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 430 at risk

Adverse event: Crying
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 430 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 430 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 430 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 430 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 430 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 430 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 430 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 430 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 430 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 430 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 430 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 430 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 430 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 430 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 114 affected / 430 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 62 affected / 430 at risk

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 128 affected / 430 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 79 affected / 430 at risk

Adverse event: Injection-site induration
Serious: no
Organ System: General disorders
Frequency: 25 affected / 430 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 78 affected / 430 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 430 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 430 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 430 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 430 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 424 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 424 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 424 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 424 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 109 affected / 424 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 57 affected / 424 at risk

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 117 affected / 424 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 73 affected / 424 at risk

Adverse event: Injection-site induration
Serious: no
Organ System: General disorders
Frequency: 15 affected / 424 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 85 affected / 424 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 39 affected / 424 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 424 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 424 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 424 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 429 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 429 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 429 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 429 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 429 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 429 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 429 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 91 affected / 429 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 56 affected / 429 at risk

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 116 affected / 429 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 60 affected / 429 at risk

Adverse event: Injection-site induration
Serious: no
Organ System: General disorders
Frequency: 24 affected / 429 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 87 affected / 429 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 39 affected / 429 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 429 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 429 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 429 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 428 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 428 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 428 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 428 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 428 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 428 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 428 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 428 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 428 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 428 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 428 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 428 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 107 affected / 428 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 53 affected / 428 at risk

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 94 affected / 428 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 66 affected / 428 at risk

Adverse event: Injection-site induration
Serious: no
Organ System: General disorders
Frequency: 8 affected / 428 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 65 affected / 428 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 428 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 428 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 428 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 428 at risk