Study: NCT01204658

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 146 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 146 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 146 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Psychomotor retardation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 146 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Accidental exposure to product by child
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 146 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Skin discolouration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 75 affected / 146 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 96 affected / 146 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods , across doses
Frequency: 82 affected / 146 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 107 affected / 146 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 118 affected / 146 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 65 affected / 146 at risk

Adverse event: Fever (rectal temperature >= 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 76 affected / 146 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 77 affected / 144 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 83 affected / 144 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 70 affected / 144 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 77 affected / 144 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 95 affected / 144 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 49 affected / 144 at risk

Adverse event: Fever (rectal temperature >= 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 50 affected / 144 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 5 affected / 146 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 6 affected / 146 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 10 affected / 146 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-booster vaccination period
Frequency: 9 affected / 144 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 11 affected / 146 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 142 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 142 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Burning sensation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 142 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 73 affected / 142 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 97 affected / 142 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods , across doses
Frequency: 74 affected / 142 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 96 affected / 142 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 113 affected / 142 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 59 affected / 142 at risk

Adverse event: Fever (rectal temperature >= 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 71 affected / 142 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 73 affected / 140 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 81 affected / 140 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 55 affected / 140 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 64 affected / 140 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 84 affected / 140 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 38 affected / 140 at risk

Adverse event: Fever (rectal temperature >= 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 55 affected / 140 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 9 affected / 142 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 12 affected / 142 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 7 affected / 142 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-booster vaccination period
Frequency: 4 affected / 140 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 11 affected / 142 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 9 affected / 142 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 145 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 145 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 145 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 145 at risk

Adverse event: Psychomotor retardation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 145 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Aphthous ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 145 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 145 at risk

Adverse event: Gastroenteritis Escherichia coli
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 145 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Hypotonic-hyporesponsive episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 145 at risk

Adverse event: Localised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 145 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Rectal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 72 affected / 144 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 88 affected / 144 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods , across doses
Frequency: 60 affected / 144 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 98 affected / 144 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 110 affected / 144 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 59 affected / 144 at risk

Adverse event: Fever (rectal temperature >= 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 74 affected / 144 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 61 affected / 139 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 68 affected / 139 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 49 affected / 139 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 66 affected / 139 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 82 affected / 139 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 36 affected / 139 at risk

Adverse event: Fever (rectal temperature >= 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 51 affected / 139 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 5 affected / 145 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 11 affected / 145 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 12 affected / 145 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-booster vaccination period
Frequency: 3 affected / 140 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 12 affected / 145 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 5 affected / 145 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 142 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 142 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 142 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 142 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 142 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Breath holding
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 142 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 142 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 142 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 142 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 142 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 142 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 64 affected / 142 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 83 affected / 142 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods , across doses
Frequency: 59 affected / 142 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 102 affected / 142 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 113 affected / 142 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 57 affected / 142 at risk

Adverse event: Fever (rectal temperature >= 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-primary vaccination periods, across doses
Frequency: 65 affected / 142 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 68 affected / 140 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 66 affected / 140 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 59 affected / 140 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 73 affected / 140 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 90 affected / 140 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 57 affected / 140 at risk

Adverse event: Fever (rectal temperature >= 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 7-day post-booster vaccination period
Frequency: 53 affected / 140 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 3 affected / 142 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 13 affected / 142 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 8 affected / 142 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-booster vaccination period
Frequency: 6 affected / 140 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 14 affected / 142 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 3 affected / 142 at risk