Table 3.
Percentage of Participants With Solicited Local and Systemic Adverse Events Within Seven Days of Vaccination From ZOE-50 and ZOE-70 Trials9,10
| ZOE-50 | ZOE-70 | |||
|---|---|---|---|---|
| Adverse Event | HZ/su % | Placebo % | HZ/su % | Placebo % |
| Injection-site reaction | 81.5 | 11.9 | 74.1 | 9.9 |
| Pain | 79.1 | 11.2 | 68.7 | 8.5 |
| Redness | 38.0 | 1.3 | 39.2 | 1.0 |
| Swelling | 26.3 | 1.1 | 22.6 | 0.4 |
| Grade 3 injection-site reaction* | 9.5 | 0.4 | 8.5 | 0.2 |
| Systemic reaction | 66.1 | 29.5 | 53.0 | 25.1 |
| Myalgia | 46.3 | 12.1 | 32.9 | 15.2 |
| Fatigue | 45.9 | 16.6 | 31.2 | 8.1 |
| Headache | 39.2 | 16.0 | 24.6 | 10.9 |
| Shivering | 28.2 | 5.9 | 14.9 | 4.4 |
| Fever | 21.5 | 3.0 | 12.3 | 2.6 |
| Gastrointestinal symptoms | 18.0 | 8.8 | 10.9 | 7.9 |
| Grade 3 systemic reaction* | 11.4 | 2.4 | 6.0 | 2.0 |
*
Diameter of injection-site redness and swelling reactions, scores: 0 for < 20 mm; 1 for 20–50 mm; 2 for > 50–100 mm; and 3 for > 100 mm.
Temperature scores: 0 for < 37.5° C; 1 for 37.5–38.0° C; and 3 for > 39.0° C. All other symptoms scores: 0 for absent, 1 for easily tolerated; 2 for interferes with normal activity; and 3 for prevents normal activity. HZ/su = herpes zoster subunit vaccine