Study: NCT00129116

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Over the full course of the booster phase (up to study Month 1 - booster phase)
Frequency: 1 affected / 47 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 21 affected / 78 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 35 affected / 78 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 31 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 39 affected / 78 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 44 affected / 78 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 24 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 25 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 11 affected / 78 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 6 affected / 78 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 6 affected / 78 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 3 affected / 78 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 3 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 3 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 1 affected / 78 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 2 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 5 affected / 47 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 20 affected / 47 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 15 affected / 47 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 14 affected / 47 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 16 affected / 47 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 11 affected / 47 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 13 affected / 47 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the booster phase)
Frequency: 5 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Over the full course of the primary phase (up to study Month 3 - primary phase)
Frequency: 1 affected / 77 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: Over the full course of the booster phase (up to study Month 1 - booster phase)
Frequency: 1 affected / 42 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Over the full course of the booster phase (up to study Month 1 - booster phase)
Frequency: 1 affected / 42 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 20 affected / 77 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 38 affected / 77 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 35 affected / 77 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 53 affected / 77 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 42 affected / 77 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 34 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 28 affected / 77 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 6 affected / 77 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 77 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 3 affected / 77 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 77 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 1 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 1 affected / 77 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 77 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 10 affected / 42 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 18 affected / 42 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 12 affected / 42 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 18 affected / 42 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 18 affected / 42 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 16 affected / 42 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 10 affected / 42 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the booster phase)
Frequency: 6 affected / 42 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Over the full course of the primary phase (up to study Month 3 - primary phase)
Frequency: 1 affected / 78 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Over the full course of the primary phase (up to study Month 3 - primary phase)
Frequency: 1 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 22 affected / 78 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 50 affected / 78 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 30 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 43 affected / 78 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 51 affected / 78 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 29 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 26 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 78 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 2 affected / 78 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 78 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 3 affected / 78 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 5 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 2 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 78 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 2 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 8 affected / 44 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 22 affected / 44 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 12 affected / 44 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 18 affected / 44 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 19 affected / 44 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 12 affected / 44 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 16 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the booster phase)
Frequency: 4 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Over the full course of the primary phase (up to study Month 3 - primary phase)
Frequency: 1 affected / 78 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: Over the full course of the booster phase (up to study Month 1 - booster phase)
Frequency: 1 affected / 44 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 19 affected / 78 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 32 affected / 78 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 27 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 37 affected / 78 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 47 affected / 78 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 33 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 28 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 8 affected / 78 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 3 affected / 78 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 2 affected / 78 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 78 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 1 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 3 affected / 78 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 1 affected / 78 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 1 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 8 affected / 44 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 16 affected / 44 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 9 affected / 44 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 17 affected / 44 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 14 affected / 44 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 10 affected / 44 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 18 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the booster phase)
Frequency: 2 affected / 44 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Over the full course of the primary phase (up to study Month 3 - primary phase)
Frequency: 1 affected / 77 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: Over the full course of the primary phase (up to study Month 3 - primary phase)
Frequency: 1 affected / 77 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Over the full course of the primary phase (up to study Month 3 - primary phase)
Frequency: 1 affected / 77 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: Over the full course of the primary phase (up to study Month 3 - primary phase)
Frequency: 1 affected / 77 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Notes: Over the full course of the primary phase (up to study Month 3 - primary phase)
Frequency: 1 affected / 77 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 19 affected / 77 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 46 affected / 77 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 35 affected / 77 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 46 affected / 77 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 44 affected / 77 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 30 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Frequency: 28 affected / 77 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 6 affected / 77 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 3 affected / 77 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 3 affected / 77 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 77 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 2 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 2 affected / 77 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 4 affected / 77 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Frequency: 2 affected / 77 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 9 affected / 44 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 16 affected / 44 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 10 affected / 44 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 18 affected / 44 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 17 affected / 44 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 14 affected / 44 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Frequency: 16 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 31-day (Day 0-30) follow-up period (during the booster phase)
Frequency: 4 affected / 44 at risk