Study: NCT01641133

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Pain (primary phase)
Serious: no
Organ System: General disorders
Frequency: 69 affected / 90 at risk

Adverse event: Redness (primary phase)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 90 at risk

Adverse event: Swelling (primary phase)
Serious: no
Organ System: General disorders
Frequency: 17 affected / 90 at risk

Adverse event: Pain (booster phase)
Serious: no
Organ System: General disorders
Frequency: 44 affected / 86 at risk

Adverse event: Redness (booster phase)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 86 at risk

Adverse event: Swelling (booster phase)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 86 at risk

Adverse event: Drowsiness (primary phase)
Serious: no
Organ System: General disorders
Frequency: 47 affected / 90 at risk

Adverse event: Irritability (primary phase)
Serious: no
Organ System: General disorders
Frequency: 62 affected / 90 at risk

Adverse event: Loss of appetite (primary phase)
Serious: no
Organ System: General disorders
Frequency: 28 affected / 90 at risk

Adverse event: Fever (primary phase)
Serious: no
Organ System: General disorders
Frequency: 28 affected / 90 at risk

Adverse event: Drowsiness (booster phase)
Serious: no
Organ System: General disorders
Frequency: 25 affected / 86 at risk

Adverse event: Irritability (booster phase)
Serious: no
Organ System: General disorders
Frequency: 33 affected / 86 at risk

Adverse event: Loss of appetite (booster phase)
Serious: no
Organ System: General disorders
Frequency: 24 affected / 86 at risk

Adverse event: Fever (booster phase)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 86 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Nasopharyngitis (primary phase)
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 97 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 97 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Nasopharyngitis (booster phase)
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 86 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 86 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Pain (primary phase)
Serious: no
Organ System: General disorders
Frequency: 63 affected / 94 at risk

Adverse event: Redness (primary phase)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 94 at risk

Adverse event: Swelling (primary phase)
Serious: no
Organ System: General disorders
Frequency: 19 affected / 94 at risk

Adverse event: Pain (booster phase)
Serious: no
Organ System: General disorders
Frequency: 44 affected / 87 at risk

Adverse event: Redness (booster phase)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 87 at risk

Adverse event: Swelling (booster phase)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 87 at risk

Adverse event: Drowsiness (primary phase)
Serious: no
Organ System: General disorders
Frequency: 44 affected / 94 at risk

Adverse event: Irritability (primary phase)
Serious: no
Organ System: General disorders
Frequency: 68 affected / 94 at risk

Adverse event: Loss of appetite (primary phase)
Serious: no
Organ System: General disorders
Frequency: 31 affected / 94 at risk

Adverse event: Fever (primary phase)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 94 at risk

Adverse event: Drowsiness (booster phase)
Serious: no
Organ System: General disorders
Frequency: 27 affected / 87 at risk

Adverse event: Irritability (booster phase)
Serious: no
Organ System: General disorders
Frequency: 39 affected / 87 at risk

Adverse event: Loss of appetite (booster phase)
Serious: no
Organ System: General disorders
Frequency: 22 affected / 87 at risk

Adverse event: Fever (booster phase)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 87 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 99 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 99 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Nasopharyngitis (primary phase)
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 99 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 99 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Nasopharyngitis (booster phase)
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 99 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: Pain (primary phase)
Serious: no
Organ System: General disorders
Frequency: 65 affected / 94 at risk

Adverse event: Redness (primary phase)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 94 at risk

Adverse event: Swelling (primary phase)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 94 at risk

Adverse event: Pain (booster phase)
Serious: no
Organ System: General disorders
Frequency: 45 affected / 85 at risk

Adverse event: Redness (booster phase)
Serious: no
Organ System: General disorders
Frequency: 17 affected / 85 at risk

Adverse event: Swelling (booster phase)
Serious: no
Organ System: General disorders
Frequency: 19 affected / 85 at risk

Adverse event: Drowsiness (primary phase)
Serious: no
Organ System: General disorders
Frequency: 55 affected / 94 at risk

Adverse event: Irritability (primary phase)
Serious: no
Organ System: General disorders
Frequency: 62 affected / 94 at risk

Adverse event: Loss of appetite (primary phase)
Serious: no
Organ System: General disorders
Frequency: 29 affected / 94 at risk

Adverse event: Fever (primary phase)
Serious: no
Organ System: General disorders
Frequency: 25 affected / 94 at risk

Adverse event: Drowsiness (booster phase)
Serious: no
Organ System: General disorders
Frequency: 26 affected / 84 at risk

Adverse event: Irritability (booster phase)
Serious: no
Organ System: General disorders
Frequency: 45 affected / 84 at risk

Adverse event: Loss of appetite (booster phase)
Serious: no
Organ System: General disorders
Frequency: 17 affected / 84 at risk

Adverse event: Fever (booster phase)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 84 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 87 at risk

Adverse event: Nasopharyngitis (primary phase)
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 98 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 98 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 98 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 98 at risk

Adverse event: Nasopharyngitis (booster phase)
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 87 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 87 at risk