Study: NCT03970733

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 97 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 97 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 97 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 97 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 93 affected / 97 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 28 affected / 97 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 31 affected / 97 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 27 affected / 97 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 24 affected / 97 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 18 affected / 97 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 8 affected / 97 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 54 affected / 97 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 24 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 45 affected / 97 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 18 affected / 97 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 2 affected / 97 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 10 affected / 97 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 7 affected / 97 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 3 affected / 97 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 2 affected / 97 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 4 affected / 97 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 2 affected / 97 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 4 affected / 97 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 4 affected / 97 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 98 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 98 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 98 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 98 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 98 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 95 affected / 98 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 41 affected / 98 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 33 affected / 98 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 29 affected / 98 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 32 affected / 98 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 9 affected / 98 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 6 affected / 98 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 5 affected / 98 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 55 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 23 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 45 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 17 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 5 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 7 affected / 98 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 6 affected / 98 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 98 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 5 affected / 98 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 2 affected / 98 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 5 affected / 98 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 5 affected / 98 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 98 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 51 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 51 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 16 affected / 51 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 8 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 13 affected / 51 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 51 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 51 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 10 affected / 51 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 51 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 11 affected / 51 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 8 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 18 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 6 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 4 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 4 affected / 51 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 5 affected / 51 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 3 affected / 51 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 3 affected / 51 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 3 affected / 51 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 51 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 2 affected / 51 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 3 affected / 51 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 39 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 39 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 39 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 35 affected / 39 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 7 affected / 39 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 8 affected / 39 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 2 affected / 39 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 3 affected / 39 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 39 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 11 affected / 39 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 4 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 8 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 3 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 39 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 5 affected / 19 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 3 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 2 affected / 19 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 19 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 19 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Includes systematic and non-systematic assessments. MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 4 affected / 19 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v24.0 was used for Main Study Phase (VLA15 lower dose, higher dose and placebo). MedDRA v25.0 was used for Booster Phase (VLA15 higher dose and placebo).
Frequency: 1 affected / 19 at risk