Study: NCT02780401

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/2 was deemed possibly related to study treatment Arm 3 - 1/1 was deemed probably related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/1 was deemed possibly related to study treatment Arm 2 - 2/2 deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/2 events was deemed possibly related as it changed in grade
Frequency: 1 affected / 10 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Arm 1 - 3/5 events were deemed related to the study treatment Arm 2 - 5/8 events were deemed related to the study treatment
Frequency: 4 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 3/5 events were deemed possibly related to study treatment
Frequency: 3 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Arm 2 - 1/5 events was deemed possibly related to study treatment
Frequency: 4 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 3 - 1/3 events was deemed possibly related to treatment
Frequency: 2 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema multiforme is unrelated to the study vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Arm 1 - 6/8 events were deemed related to study treatment Arm 2 - 4/4 events were deemed related to study treatment Arm 3 - 1/1 events was deemed possibly related to study treatment
Frequency: 5 affected / 10 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Arm 1 - 6/6 events were deemed related to study treatment Arm 2 - 10/11 events were deemed related to study treatment Arm 3 - 2/2 events were deemed related to study treatment
Frequency: 5 affected / 10 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Arm 1 - 4/4 events were deemed possibly related to study treatment Arm 2 - 1/2 events was deemed possibly related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 4/10 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 4 affected / 10 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 2: 2/4 glucose results were deemed possibly related to the study vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Note: Hypertension was defined as a reported abnormal blood pressure per protocol
Frequency: 7 affected / 10 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to the study treatment Arm 2 - 1/2 events was deemed possibly related to the study treatment Arm 3 - 1/3 events was deemed possibly related to the study treatment
Frequency: 4 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 1 - 1/1 events is deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 1 - 1/1 adverse event was deemed possibly related to study vaccination
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Arm 1 - 12/14 events were deemed related to the study treatment Arm 2 - 14/17 events were deemed related to the study treatment Arm 3 - 12/13 events were deemed related to the study treatment
Frequency: 9 affected / 10 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Notes: Arm 1 - 1/1 events was deemed probably related to the study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Arm 1 - 2/7 events was deemed possibly related to study treatment Arm 2 - 2/4 events was deemed possibly related to study treatment Arm 3 - 2/5 events was deemed possibly related to study treatment
Frequency: 7 affected / 10 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arm 1 - 3/7 events was deemed possibly related to study treatment Arm 2 - 3/7 events was deemed possibly related to study treatment
Frequency: 5 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 4/11 events was deemed possibly related to study treatment Arm 2 - 1/3 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 6 affected / 10 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Arm 1 - 1/1 events was deemed possibly related to study treatment Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/1 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 3 affected / 10 at risk

Adverse event: Oral dysaesthesia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/1 events was deemed possibly related to study
Frequency: 1 affected / 10 at risk

Adverse event: Phantom limb syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 1/6 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 4 affected / 10 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Surgical and medical procedures - Other
Serious: no
Organ System: Surgical and medical procedures
Notes: ARM 1:

1 patient: replacement of breast implants

1 patient: revision of DIEP flap reconstruction and delayed recovery from anesthesia
Frequency: 2 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Urinary tract infection (UTI)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/2 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 2/7 events was deemed possibly related to study treatment Arm 3 - 3/4 events was deemed possibly related to study treatment
Frequency: 5 affected / 10 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/1 was deemed possibly related to study treatment Arm 2 - 2/2 deemed possibly related to study treatment
Frequency: 2 affected / 12 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergic reaction was unrelated to the study vaccine
Frequency: 1 affected / 12 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/2 events was deemed possibly related as it changed in grade
Frequency: 1 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 12 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 12 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Chest pain was unrelated to study vaccine
Frequency: 1 affected / 12 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Arm 1 - 3/5 events were deemed related to the study treatment Arm 2 - 5/8 events were deemed related to the study treatment
Frequency: 5 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 3/5 events were deemed possibly related to study treatment
Frequency: 2 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Arm 2 - 1/5 events was deemed possibly related to study treatment
Frequency: 4 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 3 - 1/3 events was deemed possibly related to treatment
Frequency: 3 affected / 12 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Arm 2 - 1/3 events was deemed probably related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 3 affected / 12 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Eye Disorder - Other
Serious: no
Organ System: Eye disorders
Notes: Eye disorder was unrelated to study vaccine
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Arm 1 - 6/8 events were deemed related to study treatment Arm 2 - 4/4 events were deemed related to study treatment Arm 3 - 1/1 events was deemed possibly related to study treatment
Frequency: 3 affected / 12 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Arm 1 - 6/6 events were deemed related to study treatment Arm 2 - 10/11 events were deemed related to study treatment Arm 3 - 2/2 events were deemed related to study treatment
Frequency: 8 affected / 12 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Arm 1 - 4/4 events were deemed possibly related to study treatment Arm 2 - 1/2 events was deemed possibly related to study treatment
Frequency: 2 affected / 12 at risk

Adverse event: Biliary colic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 4/10 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 4 affected / 12 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 2: 2/4 glucose results were deemed possibly related to the study vaccine
Frequency: 4 affected / 12 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Note: Hypertension was defined as a reported abnormal blood pressure per protocol
Frequency: 2 affected / 12 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 3 - 1/1 events was deemed possibly related to study treatment
Frequency: 2 affected / 12 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to the study treatment Arm 2 - 1/2 events was deemed possibly related to the study treatment Arm 3 - 1/3 events was deemed possibly related to the study treatment
Frequency: 2 affected / 12 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 1 - 1/1 events is deemed possibly related to study treatment
Frequency: 1 affected / 12 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 2 - 2/3 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 3 affected / 12 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 1 - 1/1 adverse event was deemed possibly related to study vaccination
Frequency: 1 affected / 12 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infections and Infestations - Other
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 12 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Arm 1 - 12/14 events were deemed related to the study treatment Arm 2 - 14/17 events were deemed related to the study treatment Arm 3 - 12/13 events were deemed related to the study treatment
Frequency: 10 affected / 12 at risk

Adverse event: Complement 3
Serious: no
Organ System: Investigations
Notes: Arm 2 - 1/2 events was deemed possibly related to study treatment
Frequency: 2 affected / 12 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Arm 1 - 2/7 events was deemed possibly related to study treatment Arm 2 - 2/4 events was deemed possibly related to study treatment Arm 3 - 2/5 events was deemed possibly related to study treatment
Frequency: 4 affected / 12 at risk

Adverse event: Antinuclear antibody
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Arm 2 - 2/2 events were deemed probably related to study treatment
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arm 1 - 3/7 events was deemed possibly related to study treatment Arm 2 - 3/7 events was deemed possibly related to study treatment
Frequency: 6 affected / 12 at risk

Adverse event: Musculoskeletal and connective tissue disorder - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 4/11 events was deemed possibly related to study treatment Arm 2 - 1/3 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 3 affected / 12 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Arm 1 - 1/1 events was deemed possibly related to study treatment Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/1 events was deemed possibly related to study treatment
Frequency: 1 affected / 12 at risk

Adverse event: Neoplasms benign, malignant and unspecified - Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 12 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 1 affected / 12 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: ARM 2: 1/2 palpitations was deemed possibly related to study vaccine and was a Grade 1
Frequency: 2 affected / 12 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 1/6 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 4 affected / 12 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Arm 3 - 2/2 events was deemed possibly related to study treatment
Frequency: 1 affected / 12 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Arm 2 - 2/3 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 3 affected / 12 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/2 events was deemed possibly related to study treatment
Frequency: 1 affected / 12 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 2/7 events was deemed possibly related to study treatment Arm 3 - 3/4 events was deemed possibly related to study treatment
Frequency: 6 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/2 was deemed possibly related to study treatment Arm 3 - 1/1 was deemed probably related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Alanine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Arm 3 - 1/2 was possibly related to the study treatment as it increased in grade (in the same patient)
Frequency: 1 affected / 10 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 3/5 events were deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Arm 2 - 1/5 events was deemed possibly related to study treatment
Frequency: 5 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 3 - 1/3 events was deemed possibly related to treatment
Frequency: 3 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Arm 2 - 1/3 events was deemed probably related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Arm 3 - 1/1 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Arm 1 - 6/8 events were deemed related to study treatment Arm 2 - 4/4 events were deemed related to study treatment Arm 3 - 1/1 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Arm 1 - 6/6 events were deemed related to study treatment Arm 2 - 10/11 events were deemed related to study treatment Arm 3 - 2/2 events were deemed related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 4/10 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 3 affected / 10 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 2: 2/4 glucose results were deemed possibly related to the study vaccine
Frequency: 2 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Note: Hypertension was defined as a reported abnormal blood pressure per protocol
Frequency: 1 affected / 10 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 3 - 1/1 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to the study treatment Arm 2 - 1/2 events was deemed possibly related to the study treatment Arm 3 - 1/3 events was deemed possibly related to the study treatment
Frequency: 3 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 1 - 1/1 events is deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 2 - 2/3 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Arm 1 - 1/1 adverse event was deemed possibly related to study vaccination
Frequency: 2 affected / 10 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Arm 1 - 12/14 events were deemed related to the study treatment Arm 2 - 14/17 events were deemed related to the study treatment Arm 3 - 12/13 events were deemed related to the study treatment
Frequency: 7 affected / 10 at risk

Adverse event: Complement 3
Serious: no
Organ System: Investigations
Notes: Arm 2 - 1/2 events was deemed possibly related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Arm 1 - 2/7 events was deemed possibly related to study treatment Arm 2 - 2/4 events was deemed possibly related to study treatment Arm 3 - 2/5 events was deemed possibly related to study treatment
Frequency: 5 affected / 10 at risk

Adverse event: GAD65
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arm 1 - 3/7 events was deemed possibly related to study treatment Arm 2 - 3/7 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 4/11 events was deemed possibly related to study treatment Arm 2 - 1/3 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 3 affected / 10 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Arm 1 - 1/1 events was deemed possibly related to study treatment Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/1 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Neoplasms benign, malignant and unspecified - Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 1/6 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Arm 3 - 2/2 events was deemed possibly related to study treatment
Frequency: 2 affected / 10 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Arm 2 - 2/3 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Surgical and medical procedures - Other
Serious: no
Organ System: Surgical and medical procedures
Notes: ARM 1:

1 patient: replacement of breast implants

1 patient: revision of DIEP flap reconstruction and delayed recovery from anesthesia
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Arm 1 - 1/2 events was deemed possibly related to study treatment
Frequency: 1 affected / 10 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 2/7 events was deemed possibly related to study treatment Arm 3 - 3/4 events was deemed possibly related to study treatment
Frequency: 4 affected / 10 at risk