Study: NCT00614614

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 9 affected / 1272 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 7 affected / 1272 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 5 affected / 1272 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 3 affected / 1272 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 4 affected / 1272 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 3 affected / 1272 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 4 affected / 1272 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 3 affected / 1272 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 1272 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 1272 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 1272 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 1272 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 1272 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 1272 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Brief resolved unexplained event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Gastric volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Haemolytic uraemic syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Irritability
Serious: yes
Organ System: General disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 1272 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 282 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 282 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 3 affected / 282 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 3 affected / 282 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 282 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 2 affected / 282 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Skin burning sensation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: SAE assessed from the first primary dose up to the end of the primary ESFU period (Month 0 upto Month 10-13) for MenHibrix 1 Group and ActHIB-Infanrix Group.
Frequency: 1 affected / 282 at risk

Adverse event: Herpes oesophagitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 233 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 233 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 99 affected / 210 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Redness was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 121 affected / 210 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Swelling was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 80 affected / 210 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 79 affected / 209 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 14 affected / 209 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 114 affected / 209 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 55 affected / 209 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study.
Frequency: 9 affected / 233 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study.
Frequency: 11 affected / 233 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Adenoidectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Postoperative respiratory distress
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 5 affected / 432 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 2 affected / 432 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 3 affected / 432 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Respiratory syncitial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 432 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase.
Frequency: 156 affected / 408 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Redness was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase.
Frequency: 171 affected / 408 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Swelling was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase.
Frequency: 97 affected / 408 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 145 affected / 385 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Redness was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 175 affected / 385 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Swelling was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 114 affected / 385 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 171 affected / 408 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 46 affected / 408 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 230 affected / 408 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 144 affected / 408 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 132 affected / 384 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 34 affected / 384 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 195 affected / 384 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 117 affected / 384 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study.
Frequency: 54 affected / 432 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study.
Frequency: 34 affected / 432 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the second booster phase vaccination in Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 27 affected / 432 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the second booster phase vaccination in Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 27 affected / 432 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom experienced during the 31-day (Days 0-30) period after the second booster phase vaccination in Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 13 affected / 432 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 229 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 229 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 229 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 229 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 229 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 2 affected / 229 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase.
Frequency: 104 affected / 217 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Redness was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase.
Frequency: 90 affected / 217 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Swelling was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase.
Frequency: 54 affected / 217 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 99 affected / 197 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Redness was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 102 affected / 197 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Swelling was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 73 affected / 197 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 97 affected / 217 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 23 affected / 217 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 128 affected / 217 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 73 affected / 217 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 67 affected / 197 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 16 affected / 197 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 103 affected / 197 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 5 vaccination with Infanrix vaccine for Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 62 affected / 197 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study.
Frequency: 24 affected / 229 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study.
Frequency: 22 affected / 229 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the second booster phase vaccination in Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 13 affected / 229 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the second booster phase vaccination in Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 13 affected / 229 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptom experienced during the 31-day (Days 0-30) period after the second booster phase vaccination in Nimenrix 1 Group and MenHibrix 2 Group.
Frequency: 13 affected / 229 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Floppy infant
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 2 affected / 409 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Respiratory syncitial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from the first booster phase visit up to 6 months after the last booster phase vaccination (Month 10-13 up to Month 19-22).
Frequency: 1 affected / 409 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase.
Frequency: 170 affected / 386 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Redness was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase.
Frequency: 169 affected / 386 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Swelling was experienced during the 8-day (Days0-7) post-vaccination period following each dose with Nimenrix or MenHibrix vaccine in the booster phase.
Frequency: 105 affected / 386 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 156 affected / 374 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Redness was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 171 affected / 374 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Swelling was experienced during the 8-day (Days0-7) post-vaccination period with Infanrix vaccine in the booster phase.
Frequency: 113 affected / 374 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 161 affected / 384 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 37 affected / 384 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 218 affected / 384 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom experienced at Dose 4 vaccination with Nimenrix \[ for Nimenrix 1 Group\], MenHibrix \[ for MenHibrix 2 Group\], Nimenrix co-administered with Infanrix \[ for Nimenrix 2 Group\] and Infanrix \[ for ActHIB-Infanrix Group\].
Frequency: 138 affected / 384 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study.
Frequency: 21 affected / 409 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Symptom experienced during the 31-day (Days 0-30) period after the first or single booster phase vaccination in all groups corresponding to Booster phase of study.
Frequency: 36 affected / 409 at risk