Table 5.
Safety summary.
| VVV (n = 85) |
HHV (n = 82) |
|||
|---|---|---|---|---|
| n (%) | 95% CI | n (%) | 95% CI | |
| ≥1 AE | 83 (97.6) | 91.8, 99.7 | 76 (92.7) | 84.8, 97.3 |
| − Injection-site AEs | 71 (83.5) | 62 (75.6) | ||
| − Systemic AEs | 79 (92.9) | 69 (84.1) | ||
| Vaccine-related AEsa | 83 (97.6) | 91.8, 99.7 | 76 (92.7) | 84.8, 97.3 |
| − Injection-site AEs | 71 (83.5) | 62 (75.6) | ||
| − Systemic AEs | 79 (92.9) | 68 (82.9) | ||
| Serious AEs | 0 (0.0) | 0.0, 4.2 | 1 (1.2) | 0.0, 6.6 |
| − Serious vaccine-related AEs | 0 (0.0) | 0.0, 4.2 | 0 (0.0) | 0.0, 4.4 |
| Deaths | 0 (0.0) | 0.0, 4.2 | 0 (0.0) | 0.0, 4.4 |
| Solicited injection-site AEs | 71 (83.5) | 73.9, 90.7 | 62 (75.6) | 64.9, 84.4 |
| − Injection-site erythema | 45 (52.9) | 41.8, 63.9 | 41 (50.0) | 38.7, 61.3 |
| − Injection-site pain | 63 (74.1) | 63.5, 83.0 | 46 (56.1) | 44.7, 67.0 |
| − Injection-site swelling | 45 (52.9) | 41.8, 63.9 | 33 (40.2) | 29.6, 51.7 |
| Solicited systemic AEs | 78 (91.8) | 83.8, 96.6 | 57 (69.5) | 58.4, 79.2 |
| − Decreased appetite | 37 (43.5) | 32.8, 54.7 | 30 (36.6) | 26.2, 48.0 |
| − Irritability | 66 (77.6) | 67.3, 86.0 | 48 (58.5) | 47.1, 69.3 |
| − Somnolence | 55 (64.7) | 53.6, 74.8 | 39 (47.6) | 36.4, 58.9 |
| − Vomiting | 3 (3.5) | 0.7, 10.0 | 7 (8.5) | 3.5, 16.8 |
aDetermined by the investigator to be related to the vaccine.
Reported AEs include non-serious AEs days 1–15 after vaccination and serious AEs from enrollment to study completion