Table 5. Treatment–related treatment-emergent adverse events (TEAE) in the safety population.
System organ class Number (%) of participants |
Vacc-4x Safety population (n = 33) |
---|---|
General disorders and administration site conditions Application site pruritus Injection site pruritus Injection site erythema Influenza-like illness Asthenia Application site reaction Injection site vesicles Fatigue Application site erythema Application site induration Chest discomfort Chills Injection site pain Injection site reaction |
21 (63.6%) 16 (48.5%) 13 (39.4%) 4 (12.1%) 2 (6.1%) 2 (6.1%) 2 (6.1%) 2 (6.1%) 1 (3.0%) 1 (3.0%) 1 (3.0%) 1 (3.0%) 1 (3.0%) 1 (3.0%) 1 (3.0%) |
Musculoskeletal and connective tissue disorders Pain in extremity |
1 (3.0%) 1 (3.0%) |
Nervous system Headache Paraesthesia Aphasia Memory impairment |
2 (6.1%) 1 (3.0%) 1 (3.0%) 1 (3.0%) 1 (3.0%) |
Skin and subcutaneous disorders Hyperhidrosis Night sweats Erythema Seborrhoeic dermatitis |
4 (12.1%) 2 (6.1%) 1 (3.0%) 1 (3.0%) 1 (3.0%) |
Gastrointestinal disorders Nausea Abdominal pain |
1 (3.0%) 1 (3.0%) 1 (3.0%) |
Investigations Aspartate aminotransferase increased |
1 (3.0%) 1 (3.0%) |
All treatment-related TEAEs are presented. Those listed in bold correspond to >10% of participants.