Study: NCT01616459

Adverse event: Conjunctivitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 5 affected / 240 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 5 affected / 240 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 240 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 3 affected / 240 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 240 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Escherichia pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Gastroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Retinoblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 140 affected / 240 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 132 affected / 240 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 108 affected / 240 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 185 affected / 240 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 202 affected / 240 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 124 affected / 240 at risk

Adverse event: Fever (rectal temperature ≥ 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 153 affected / 240 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 38 affected / 240 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: 18 affected / 240 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 12 affected / 240 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: 10 affected / 240 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 / 240 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 112 affected / 235 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 109 affected / 235 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 84 affected / 235 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 109 affected / 235 at risk

Adverse event: Irritability/Fusiness
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 140 affected / 235 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 80 affected / 235 at risk

Adverse event: Fever (rectal temperature ≥ 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 80 affected / 235 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-booster vaccination period
Frequency: 11 affected / 237 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 4 affected / 240 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 240 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 240 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 240 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Adenoiditis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Exposure to toxic agent
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Ingrowing nail
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Pyomyositis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Viral tonsillitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 240 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 141 affected / 236 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 144 affected / 236 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 117 affected / 236 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 178 affected / 236 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 203 affected / 236 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 132 affected / 236 at risk

Adverse event: Fever (rectal temperature ≥ 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 144 affected / 236 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 39 affected / 240 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: 15 affected / 240 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 10 affected / 240 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: 7 affected / 240 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: 14 affected / 240 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 123 affected / 224 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 117 affected / 224 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 88 affected / 224 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 100 affected / 224 at risk

Adverse event: Irritability/Fusiness
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 136 affected / 224 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 85 affected / 224 at risk

Adverse event: Fever (rectal temperature ≥ 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 72 affected / 224 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-booster vaccination period
Frequency: 16 affected / 226 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 230 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 7 affected / 230 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 3 affected / 230 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 4 affected / 230 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 5 affected / 230 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 3 affected / 230 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Urinary tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 230 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 230 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 230 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 230 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Burning sensation
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Pharyngotonsillitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 230 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 134 affected / 228 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 130 affected / 228 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 91 affected / 228 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 162 affected / 228 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 185 affected / 228 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 125 affected / 228 at risk

Adverse event: Fever (rectal temperature ≥ 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 148 affected / 228 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 49 affected / 230 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 / 230 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 13 affected / 230 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: 18 affected / 230 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 / 230 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 119 affected / 219 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 108 affected / 219 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 89 affected / 219 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 84 affected / 219 at risk

Adverse event: Irritability/Fusiness
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 137 affected / 219 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 83 affected / 219 at risk

Adverse event: Fever (rectal temperature ≥ 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 68 affected / 219 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-booster vaccination period
Frequency: 20 affected / 222 at risk

Adverse event: Bacterial pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 3 affected / 241 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 4 affected / 241 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 241 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 2 affected / 241 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Hypotonic-hyporesponsive episode
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Dacryostenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Paronychia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and Month 11
Frequency: 1 affected / 241 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 126 affected / 238 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 134 affected / 238 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 93 affected / 238 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 168 affected / 238 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 186 affected / 238 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 125 affected / 238 at risk

Adverse event: Fever (rectal temperature ≥ 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-primary vaccination periods , across doses
Frequency: 143 affected / 238 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 28 affected / 241 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: 16 affected / 241 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses
Frequency: 11 affected / 241 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: 16 affected / 241 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: 11 affected / 241 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 110 affected / 231 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 107 affected / 231 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 85 affected / 231 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 96 affected / 231 at risk

Adverse event: Irritability/Fusiness
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 129 affected / 231 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 61 affected / 231 at risk

Adverse event: Fever (rectal temperature ≥ 38°C)
Serious: no
Organ System: General disorders
Notes: Symptom reported during the 4-day post-booster vaccination period
Frequency: 75 affected / 231 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-booster vaccination period
Frequency: 13 affected / 234 at risk