Safety and reactogenicity in TVC
| . | Data . |
|---|---|
| AEs | |
| Any grade | 139/151 (92.1); 86.5-95.8 |
| Grade 3 | 49/151 (32.5); 25.1-40.5 |
| Injection site AEs | |
| All types | |
| Any grade | 131/150 (87.3); 80.9-92.2 |
| Grade 3 | 28/150 (18.7); 12.8-25.8 |
| Pain | |
| Any grade | 129/150 (86.0); 79.4-91.1 |
| Grade 3 | 24/150 (16.0); 10.5-22.9 |
| Redness | |
| Any grade | 34/149 (22.8); 16.3-30.4 |
| Grade 3 | 7/149 (4.7); 1.9-9.4 |
| Swelling | |
| Any grade | 34/149 (22.8); 16.3-30.4 |
| Grade 3 | 3/149 (2.0); 0.4-5.8 |
| General AEs | |
| Any AE | |
| Any grade | 125/151 (82.8); 75.8-88.4 |
| Grade 3 | 40/151 (26.5); 19.6-34.3 |
| Fever | |
| Any grade | 34/149 (22.8); 16.3-30.4 |
| Grade 3 | 4/149 (2.7); 0.7-6.7 |
| Headache | |
| Any grade | 69/150 (46.0); 37.8-54.3 |
| Grade 3 | 10/150 (6.7); 3.2-11.9 |
| Fatigue | |
| Any grade | 106/151 (70.2); 62.2-77.4 |
| Grade 3 | 27/151 (17.9); 12.1-24.9 |
| Gastrointestinal | |
| Any grade | 58/150 (38.7); 30.8-47.0 |
| Grade 3 | 8/150 (5.3); 2.3-10.2 |
| Myalgia | |
| Any grade | 88/149 (59.1); 50.7-67.0 |
| Grade 3 | 17/149 (11.4); 6.8-17.6 |
| Shivering | |
| Any grade | 54/150 (36.0); 28.3-44.2 |
| Grade 3 | 11/150 (7.3); 3.7-12.7 |
| Unsolicited AEs | |
| Within 30 d of vaccination | 11/150 (7.3); 3.7-12.7 |
| Related to trial intervention* | 6/150 (4.0); 1.5-8.5 |
| SAEs† | |
| Within 30 d of vaccination‡ | 2/150 (1.3); 0.2-4.7 |
| Within total follow-up period | 2/150 (1.3); 0.2-4.7 |
| Relapse of malignancy | 13/158 (8.2); 4.5-13.7 |
| Death | 5/158 (3.2); 1.0-7.2 |
| . | Data . |
|---|---|
| AEs | |
| Any grade | 139/151 (92.1); 86.5-95.8 |
| Grade 3 | 49/151 (32.5); 25.1-40.5 |
| Injection site AEs | |
| All types | |
| Any grade | 131/150 (87.3); 80.9-92.2 |
| Grade 3 | 28/150 (18.7); 12.8-25.8 |
| Pain | |
| Any grade | 129/150 (86.0); 79.4-91.1 |
| Grade 3 | 24/150 (16.0); 10.5-22.9 |
| Redness | |
| Any grade | 34/149 (22.8); 16.3-30.4 |
| Grade 3 | 7/149 (4.7); 1.9-9.4 |
| Swelling | |
| Any grade | 34/149 (22.8); 16.3-30.4 |
| Grade 3 | 3/149 (2.0); 0.4-5.8 |
| General AEs | |
| Any AE | |
| Any grade | 125/151 (82.8); 75.8-88.4 |
| Grade 3 | 40/151 (26.5); 19.6-34.3 |
| Fever | |
| Any grade | 34/149 (22.8); 16.3-30.4 |
| Grade 3 | 4/149 (2.7); 0.7-6.7 |
| Headache | |
| Any grade | 69/150 (46.0); 37.8-54.3 |
| Grade 3 | 10/150 (6.7); 3.2-11.9 |
| Fatigue | |
| Any grade | 106/151 (70.2); 62.2-77.4 |
| Grade 3 | 27/151 (17.9); 12.1-24.9 |
| Gastrointestinal | |
| Any grade | 58/150 (38.7); 30.8-47.0 |
| Grade 3 | 8/150 (5.3); 2.3-10.2 |
| Myalgia | |
| Any grade | 88/149 (59.1); 50.7-67.0 |
| Grade 3 | 17/149 (11.4); 6.8-17.6 |
| Shivering | |
| Any grade | 54/150 (36.0); 28.3-44.2 |
| Grade 3 | 11/150 (7.3); 3.7-12.7 |
| Unsolicited AEs | |
| Within 30 d of vaccination | 11/150 (7.3); 3.7-12.7 |
| Related to trial intervention* | 6/150 (4.0); 1.5-8.5 |
| SAEs† | |
| Within 30 d of vaccination‡ | 2/150 (1.3); 0.2-4.7 |
| Within total follow-up period | 2/150 (1.3); 0.2-4.7 |
| Relapse of malignancy | 13/158 (8.2); 4.5-13.7 |
| Death | 5/158 (3.2); 1.0-7.2 |
Participants with missing symptom diaries at V1 or V2 were removed for missing data unless grade 3 was reported. Data are n/N (%); 95% CI.
The 6 unsolicited AEs related to the trial intervention were injection site pain (n = 1), bone pain (n = 1), pruritus (n = 2), rash (n = 1), and dizziness (n = 1).
SAEs were defined as events that were life-threatening, required hospitalization or prolonged hospitalization, or resulted in disability or incapacity or birth defect in offspring.
The 2 SAEs that may be related to vaccination were hospitalization for metabolic acidosis and weakness 3 days after V1 and hospitalization for fever and weakness 3 days after V1.