Study: NCT01262872

Adverse event: Fever (axillary temperature ≥ 37.5°C)
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period in Cohort 1
Frequency: 4 affected / 60 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination period in Cohort 1
Frequency: 5 affected / 60 at risk

Adverse event: Fever (axillary temperature ≥ 37.5°C)
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period in Cohort 1
Frequency: 2 affected / 60 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination period in Cohort 1
Frequency: 1 affected / 60 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 108 affected / 200 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 30 affected / 200 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 43 affected / 200 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 139 affected / 200 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 32 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 105 affected / 200 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 6 affected / 200 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 80 affected / 200 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 12 affected / 200 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 121 affected / 200 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 45 affected / 200 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 46 affected / 200 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 133 affected / 200 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 30 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 104 affected / 200 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 4 affected / 200 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 68 affected / 200 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 14 affected / 200 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 123 affected / 200 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 40 affected / 200 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 38 affected / 200 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 141 affected / 200 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 27 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 106 affected / 200 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 10 affected / 200 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 80 affected / 200 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 12 affected / 200 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 115 affected / 200 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 37 affected / 200 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 44 affected / 200 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 136 affected / 200 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 34 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day post-vaccination period, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 106 affected / 200 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 6 affected / 200 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 80 affected / 200 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day post-vaccination periods, across doses - in Cohort 2 3+0 Schedule subjects
Frequency: 10 affected / 200 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 97 affected / 200 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 35 affected / 200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day period after vaccination with Dose 3 - in Cohort 2 2+1 Schedule subjects
Frequency: 21 affected / 191 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited general symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 47 affected / 200 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Solicited general symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 131 affected / 200 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited general symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 24 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 93 affected / 200 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited general symptom reported during the 4-day period after vaccination with Dose 3 - in Cohort 2 2+1 Schedule subjects
Frequency: 12 affected / 191 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Solicited general symptom during the 4-day period after vaccination with Dose 3 - in Cohort 2 2+1 Schedule subjects
Frequency: 27 affected / 191 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day period after vaccination with Dose 3 - in Cohort 2 2+1 Schedule subjects
Frequency: 32 affected / 191 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day period after vaccination with the first 2 doses - in Cohort 2 2+1 Schedule subjects
Frequency: 56 affected / 200 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 102 affected / 200 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 31 affected / 200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Solicited local symptom reported during the 4-day period after vaccination with Dose 3 - in Cohort 2 2+1 Schedule subjects
Frequency: 26 affected / 195 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited general symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 44 affected / 200 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Solicited general symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 128 affected / 200 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited general symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 25 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day periods after vaccination with Doses 1 and 2, across doses - in Cohort 2 2+1 Schedule subjects
Frequency: 89 affected / 200 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Solicited general symptom reported during the 4-day period after vaccination with Dose 3 - in Cohort 2 2+1 Schedule subjects
Frequency: 4 affected / 195 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Solicited general symptom during the 4-day period after vaccination with Dose 3 - in Cohort 2 2+1 Schedule subjects
Frequency: 19 affected / 195 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited general symptom reported during the 4-day period after vaccination with Dose 3 - in Cohort 2 2+1 Schedule subjects
Frequency: 27 affected / 195 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited AE reported during the 31-day period after vaccination with the first 2 doses - in Cohort 2 2+1 Schedule subjects
Frequency: 58 affected / 200 at risk