Table 2.
Solicited Local Reactions and Systemic Adverse Events Within 7 Days of Vaccination in the Safety Analysis Set, by Study Group
| Variable | Placebo Group (n = 153) | 15/50 Vaccine Group (n = 145) | 50/50 Vaccine (n = 154) |
|---|---|---|---|
| Injection site reaction | |||
| Any | 12 (7.8) | 93 (64.1) | 112 (72.7) |
| Pain | |||
| Any | 12 (7.8) | 93 (64.1) | 112 (72.7) |
| Severe | 0 | 2 (1.4) | 2 (1.3) |
| Erythema | 0 | 0 | 1 (0.6) |
| Induration | 0 | 2 (1.4) | 2 (1.3) |
| Swelling | 0 | 3 (2.1) | 2 (1.3) |
| Systemic adverse event | |||
| Any | 41 (26.8) | 48 (33.1) | 70 (45.5) |
| Fever, °C | |||
| ≥38.0 | 0 | 1 (0.7) | 0 |
| ≥38.5 | 0 | 0 | 0 |
| Headache | |||
| Any | 25 (16.3) | 23 (15.9) | 28 (18.2) |
| Severe | 0 | 1 (0.7) | 0 |
| Fatigue | |||
| Any | 26 (17.0) | 23 (15.9) | 25 (16.2) |
| Severe | 1 (0.7) | 3 (2.1) | 1 (0.6) |
| Myalgia | |||
| Any | 11 (7.2) | 28 (19.3) | 39 (25.3) |
| Severe | 0 | 3 (2.1) | 1 (0.6) |
| Arthralgia | |||
| Any | 5 (3.3) | 7 (4.8) | 12 (7.8) |
| Severe | 0 | 0 | 0 |
| Vomiting | |||
| Any | 2 (1.3) | 2 (1.4) | 3 (1.9) |
| Severe | 0 | 0 | 0 |
| Diarrhea | |||
| Any | 12 (7.8) | 11 (7.6) | 16 (10.4) |
| Severe | 1 (0.7) | 0 | 0 |
Data are no. (%) of subjects.