Table 2 Related grade 1 and 2 AEs using MedDRA terminology during the immunization phase Days −2 to +42).
System organ class | Preferred term | Vaccine (N = 13) | Placebo (N = 7) |
|---|---|---|---|
Blood and lymphatic system disorders | Lymphopenia | [1] 1 (7.7%) | – |
#Total | [1] 1 (7.7%) | – | |
Cardiac disorders | Tachycardia | [2] 2 (15.4%) | – |
#Total | [2] 2 (15.4%) | – | |
Gastrointestinal and abdominal pains (excl. oral and throat) | Abdominal pain | [1] 1 (7.7%) | [2] 1 (14.3%) |
#Total | [1] 1 (7.7%) | [2] 1 (14.3%) | |
Gastrointestinal disorders | Diarrhea | [2] 2 (15.4%) | [1] 1 (14.3%) |
Nausea | [7] 6 (46.2%) | [3] 2 (28.6%) | |
#Total | [9] 7 (53.8%) | [4] 3 (42.9%) | |
General disorders and administration site conditions | Chills | [3] 3 (23.1%) | [1] 1 (14.3%) |
Fatigue | [16] 9 (69.2%) | [3] 3 (42.9%) | |
Hyperhidrosis | [4] 4 (30·8%) | – | |
Malaise | [4] 3 (23.1%) | – | |
Pyrexia | [8] 5 (38.5%) | [1] 1 (14.3%) | |
#Total | [35] 10 (76.9%) | [5] 3 (42.9%) | |
Infections and infestations | Oral herpes | – | [1] 1 (14.3%) |
#Total | – | [1] 1 (14.3%) | |
Musculoskeletal and connective tissue disorders | Back pain | [1] 1 (7.7%) | – |
Myalgia | [5] 4 (30.8%) | [1] 1 (14.3%) | |
#Total | [6] 4 (30.8%) | [1] 1 (14.3%) | |
Nervous system disorders | Dizziness | [15] 7 (53.8%) | [4] 2 (28.6%) |
Headache | [35] 12 (92.3%) | [8] 4 (57.1%) | |
Paresthesia | [1] 1 (7.7%) | – | |
Vision blurred | [3] 2 (15.4%) | – | |
#Total | [54] 12 (92.3%) | [12] 5 (71.4%) | |
Psychiatric disorders | Depersonalization/derealization disorder | – | [1] 1 (14.3%) |
#Total | – | [1] 1 (14.3%) | |
Respiratory, thoracic, and mediastinal disorders | Tachypnoea | [1] 1 (7.7%) | – |
#Total | [1] 1 (7.7%) | – |
