Study: NCT01711736

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 299 at risk

Adverse event: Amoebic dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 299 at risk

Adverse event: Bacterial pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 299 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 299 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 299 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 299 at risk

Adverse event: Pharyngitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 299 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 299 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 299 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 95 affected / 299 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 93 affected / 290 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Frequency: 118 affected / 290 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 99 affected / 290 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Assessed during the 7-day (Days 0-6) post-vaccination period
Frequency: 61 affected / 290 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Assessed duringthe 4-day (Days 0-3) post-vaccination period
Frequency: 46 affected / 290 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 78 affected / 299 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 299 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 302 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 302 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Blastocystis infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 91 affected / 302 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 88 affected / 296 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Frequency: 123 affected / 296 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 100 affected / 296 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Assessed during the 7-day (Days 0-6) post-vaccination period
Frequency: 60 affected / 296 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Assessed duringthe 4-day (Days 0-3) post-vaccination period
Frequency: 42 affected / 296 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 90 affected / 302 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 302 at risk