Study: NCT00129129

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 4 affected / 287 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 3 affected / 287 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 3 affected / 287 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Bronchial hyper reactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Erythema infectiosum
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Congenital retinoblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups
Frequency: 1 affected / 287 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 287 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: During 4th Dose Phase, from the administration of Dose 4 at Month 10-13 up to Day 31 thereafter, Day 31 not included. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 236 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: During 4th Dose Phase, from Day 31 after administration of Dose 4up to 6 months thereafter. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 3 affected / 236 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: During 4th Dose Phase, from Day 31 after administration of Dose 4 up to 6 months thereafter. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 2 affected / 236 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: During 4th Dose Phase, from Day 31 after administration of Dose 4up to 6 months thereafter. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 236 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: During 4th Dose Phase, from Day 31 after administration of Dose 4 up to 6 months thereafter. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 236 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: During 4th Dose Phase, from Day 31 after administration of Dose 4up to 6 months thereafter. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 236 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 129 affected / 286 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 112 affected / 286 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 90 affected / 286 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 129 affected / 286 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 113 affected / 286 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 90 affected / 286 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 185 affected / 286 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 110 affected / 286 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 217 affected / 286 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 123 affected / 286 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 187 affected / 286 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 115 affected / 286 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 222 affected / 286 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 127 affected / 286 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 77 affected / 287 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 67 affected / 287 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 29 affected / 287 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 21 affected / 287 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 15 affected / 287 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 13 affected / 287 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 11 affected / 287 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day (Days 0-30) follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups.
Frequency: 11 affected / 287 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day (Days 0-30) follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups.
Frequency: 15 affected / 287 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day (Days 0-30) follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups.
Frequency: 16 affected / 287 at risk

Adverse event: Limb circumference
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 59 affected / 232 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), solely from subjects with data available.
Frequency: 79 affected / 232 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), solely from subjects with data available.
Frequency: 81 affected / 232 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 49 affected / 232 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 72 affected / 232 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 40 affected / 232 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 114 affected / 232 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 46 affected / 232 at risk

Adverse event: Limb circumference
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 61 affected / 232 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 79 affected / 232 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 81 affected / 232 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 49 affected / 232 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 79 affected / 232 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 54 affected / 232 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 125 affected / 232 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 56 affected / 232 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during 4th Dose Phase (study 102015), within the 31-day follow-up period after 4th-dose vaccination. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups
Frequency: 26 affected / 236 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during 4th Dose Phase (study 102015), within the 31-day follow-up period after 4th-dose vaccination. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups
Frequency: 22 affected / 236 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited AE reported during 4th Dose Phase (study 102015), within the 31-day follow-up period after 4th-dose vaccination. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups
Frequency: 19 affected / 236 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 5 affected / 319 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 6 affected / 319 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 2 affected / 319 at risk

Adverse event: Arachnoid cyst
Serious: yes
Organ System: Nervous system disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Burns first degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Dyskinesia
Serious: yes
Organ System: Nervous system disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Gastro esophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Infantile spasms
Serious: yes
Organ System: Nervous system disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Tuberous sclerosis complex
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: During the entire Primary Phase of the study (study 101858), including the 6-month safety follow-up period. Groups assessed were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 319 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 171 affected / 317 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 148 affected / 317 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 110 affected / 317 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 171 affected / 317 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 148 affected / 317 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 111 affected / 317 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 224 affected / 317 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 150 affected / 317 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 268 affected / 317 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 4 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 159 affected / 317 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 227 affected / 317 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 158 affected / 317 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 272 affected / 317 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During Primary Phase (study 101858), within the 8 days following primary vaccination course. Primary Phase solicited symptoms reports were collected from the MenHibrix and ActHIB groups only, solely from subjects with data available.
Frequency: 164 affected / 317 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 71 affected / 319 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 55 affected / 319 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 18 affected / 319 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 25 affected / 319 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 21 affected / 319 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 23 affected / 319 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 18 affected / 319 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day (Days 0-30) follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups.
Frequency: 21 affected / 319 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day (Days 0-30) follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups.
Frequency: 16 affected / 319 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day (Days 0-30) follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups.
Frequency: 7 affected / 319 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 4 affected / 150 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 6 affected / 150 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 3 affected / 150 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 2 affected / 150 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups
Frequency: 4 affected / 150 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited AE reported during Primary Phase (study 101858), within the 31-day (Days 0-30) follow-up period after primary vaccination course. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB and Menomune groups.
Frequency: 1 affected / 150 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: During 4th Dose Phase, from the administration of Dose 4 at Month 10-13 up to Day 31 thereafter, Day 31 not included. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 132 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During 4th Dose Phase, from the administration of Dose 4 at Month 10-13 up to Day 31 thereafter, Day 31 not included. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 132 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: During 4th Dose Phase, from Day 31 after administration of Dose 4up to 6 months thereafter. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 132 at risk

Adverse event: Limb circumference
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 36 affected / 130 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), solely from subjects with data available.
Frequency: 48 affected / 130 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), solely from subjects with data available.
Frequency: 38 affected / 130 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 20 affected / 130 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 41 affected / 131 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 14 affected / 131 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 58 affected / 131 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 30 affected / 131 at risk

Adverse event: Limb circumference
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 36 affected / 130 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 48 affected / 130 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 39 affected / 130 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 20 affected / 130 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 43 affected / 131 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 19 affected / 131 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 62 affected / 131 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 33 affected / 131 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during 4th Dose Phase (study 102015), within the 31-day follow-up period after 4th-dose vaccination. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups
Frequency: 12 affected / 132 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during 4th Dose Phase (study 102015), within the 31-day follow-up period after 4th-dose vaccination. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups
Frequency: 5 affected / 132 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited AE reported during 4th Dose Phase (study 102015), within the 31-day follow-up period after 4th-dose vaccination. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups
Frequency: 5 affected / 132 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Notes: During 4th Dose Phase, from the administration of Dose 4 at Month 10-13 up to Day 31 thereafter, Day 31 not included. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 130 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: During 4th Dose Phase, from the administration of Dose 4 at Month 10-13 up to Day 31 thereafter, Day 31 not included. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 130 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: During 4th Dose Phase, from the administration of Dose 4 at Month 10-13 up to Day 31 thereafter, Day 31 not included. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 130 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: During 4th Dose Phase, from Day 31 after administration of Dose 4up to 6 months thereafter. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 130 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Notes: During 4th Dose Phase, from Day 31 after administration of Dose 4 up to 6 months thereafter. Groups assessed were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups.
Frequency: 1 affected / 130 at risk

Adverse event: Limb circumference
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 44 affected / 126 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), solely from subjects with data available.
Frequency: 42 affected / 126 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), solely from subjects with data available.
Frequency: 40 affected / 126 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 19 affected / 126 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 48 affected / 126 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 19 affected / 126 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 65 affected / 126 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 8 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 34 affected / 126 at risk

Adverse event: Limb circumference
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 46 affected / 126 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 42 affected / 126 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 40 affected / 126 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 19 affected / 126 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 48 affected / 126 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 24 affected / 126 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 67 affected / 126 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During 4th Dose Phase (study 102015), within the 4 days after 4th dose vaccination. Symptom reports were collected from all groups in this phase (MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups), from subjects with data available.
Frequency: 35 affected / 126 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during 4th Dose Phase (study 102015), within the 31-day follow-up period after 4th-dose vaccination. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups
Frequency: 11 affected / 130 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during 4th Dose Phase (study 102015), within the 31-day follow-up period after 4th-dose vaccination. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups
Frequency: 10 affected / 130 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited AE reported during 4th Dose Phase (study 102015), within the 31-day follow-up period after 4th-dose vaccination. Group assessed for unsolicited AEs during that period were the MenHibrix, ActHIB/ActHIB and ActHIB/MenHibrix groups
Frequency: 3 affected / 130 at risk