Study: NCT00317473

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Notes: Cohort A, Imm 3 (death from Anemia)
Frequency: 1 affected / 90 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Convulstions
Serious: yes
Organ System: Nervous system disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetate
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injections site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Small plaques
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Furuncle
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Injection site induration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Micturition disorder
Serious: no
Organ System: Renal and urinary disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Foriegn body in throat
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Enterobiasis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Post-1
Frequency: 1 affected / 90 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Marlaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Foriegn body in nostril
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Body tinea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivtis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Body tinea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: History of fever
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: History of fever
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Post-1
Frequency: 1 affected / 90 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Pre-1
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Pre-1
Frequency: 1 affected / 90 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Post-1
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: History of fever
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: SBPT increased
Serious: no
Organ System: Investigations
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Septic lesion left pinna
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Helminthiasis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Stomatitis ulceratived
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Micturition disorder
Serious: no
Organ System: Renal and urinary disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Helminthiasis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Pre-1
Frequency: 1 affected / 90 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Anorectal disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Pre-1
Frequency: 1 affected / 90 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Conjuctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Post-1
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Post-1
Frequency: 1 affected / 90 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Post-1
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Gluteal ulcer
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: History of fever
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Helminthiasis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Upper resporatory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Marlaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: History of fever
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Upper respriatory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 90 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Septic wound secondary to trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 1
Frequency: 1 affected / 90 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Upper respitratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Helminthiasis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: History of fever
Serious: no
Organ System: General disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Pruritus
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort A, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort A, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort A, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Upper respitratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Conjuntivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Post-1
Frequency: 1 affected / 45 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Post-1
Frequency: 1 affected / 45 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Post-1
Frequency: 1 affected / 45 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: General disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Pruritis ani
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort B, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort B, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Cohort B, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: History of fever
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Upper respriatory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Otitis exrterna
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: History of fever
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: General disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Monilliasis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Septic wound
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 1
Frequency: 1 affected / 45 at risk

Adverse event: Helminthiasis
Serious: no
Organ System: Infections and infestations
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 2
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Cohort C, Imm 3
Frequency: 1 affected / 45 at risk