Study: NCT00586612

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 163 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 163 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 163 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 163 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 163 at risk

Adverse event: Candida infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 163 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 163 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 163 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 3 affected / 163 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 163 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 163 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 163 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 106 affected / 163 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 94 affected / 163 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 91 affected / 163 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 111 affected / 163 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 89 affected / 163 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 128 affected / 163 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 99 affected / 163 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster dose
Frequency: 82 affected / 154 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster dose
Frequency: 77 affected / 154 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Within 4-days after booster vaccination
Frequency: 67 affected / 154 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster vaccination
Frequency: 33 affected / 154 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster vaccination
Frequency: 43 affected / 154 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster vaccination
Frequency: 70 affected / 154 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster vaccination
Frequency: 34 affected / 154 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 150 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Meningococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 150 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 24 affected / 150 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 150 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 150 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 9 affected / 150 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 100 affected / 150 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 123 affected / 150 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 113 affected / 150 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 102 affected / 150 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 85 affected / 150 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 105 affected / 150 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Within 4 days after primary vaccination
Frequency: 100 affected / 150 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster dose
Frequency: 98 affected / 144 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster dose
Frequency: 109 affected / 144 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Within 4-days after booster vaccination
Frequency: 94 affected / 144 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster vaccination
Frequency: 46 affected / 144 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster vaccination
Frequency: 53 affected / 144 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster vaccination
Frequency: 69 affected / 144 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Within 4 days after booster vaccination
Frequency: 50 affected / 144 at risk