Table 2:
All ZPIV (N=30) | Placebo (N=6) | |
---|---|---|
Local symptoms | ||
Any local symptom | 26 (87%) | 3 (50%) |
Mild | 23 (77%) | 3 (50%) |
Moderate | 3 (10%) | 0 |
Erythema | 26 (87%) | 3 (50%) |
Mild | 23 (77%) | 3 (50% |
Moderate | 3 (10%) | 0 |
Induration (severity) | 4 (13%) | 1 (17%) |
Mild | 4 (13%) | 1 (17%) |
Moderate | 0 | 0 |
Induration (size) | 4 (13%) | 1 (17%) |
Mild | 4 (13%) | 1 (17%) |
Moderate | 0 | 0 |
Pruritus | 1 (3%) | 0 |
Mild | 1 (3%) | 0 |
Moderate | 0 | 0 |
Pain | 24 (80%) | 2 (33%) |
Mild | 21 (70%) | 2 (33%) |
Moderate | 3 (10%) | 0 |
Systemic symptoms | ||
Any systemic symptom | 24 (80%) | 4 (67%) |
Mild | 18 (60%) | 3 (50%) |
Moderate | 6 (20%) | 1 (17%) |
Abdominal Pain | 3 (10%) | 1 (17%) |
Mild | 2 (7%) | 0 |
Moderate | 1 (3%) | 1 (17%) |
Arthralgia | 2 (7%) | 0 |
Mild | 2 (7%) | 0 |
Moderate | 0 | 0 |
Diarrhea | 5 (17%) | 0 |
Mild | 5 (17%) | 0 |
Moderate | 0 | 0 |
Fatigue | 16 (53%) | 1 (17%) |
Mild | 12 (40%) | 1 (17%) |
Moderate | 4 (13%) | 0 |
Feverishness | 4 (13%) | 1 (17%) |
Mild | 3 (10%) | 1 (17%) |
Moderate | 1 (3%) | 0 |
Headache | 14 (46%) | 2 (33%) |
Mild | 10 (33%) | 2 (33%) |
Moderate | 4 (13%) | 0 |
Malaise | 10 (34%) | 1 (17%) |
Mild | 8 (27%) | 1 (17%) |
Moderate | 2 (7%) | 0 |
Myalgia | 13 (44%) | 1 (17%) |
Mild | 11 (37%) | 1 (17%) |
Moderate | 2 (7%) | 0 |
Nausea | 7 (23%) | 1 (17%) |
Mild | 6 (20%) | 1 (17%) |
Moderate | 1 (3%) | 0 |
Rash | 1 (3%) | 0 |
Mild | 0 | 0 |
Moderate | 1 (3%) | 0 |
Fever | 1 (3%) | 0 |
Mild | 0 | 0 |
Moderate | 1 (3%) | 0 |
Vomiting | 2 (7%) | 0 |
Mild | 2 (7%) | 0 |
Moderate | 0 | 0 |
N = Number of participants in the Safety Population who received the specified dose. ZPIV=Alum-adjuvanted Zika purified inactivated vaccine.