AE, n (%) |  < 65 years (n = 79) |  ≥ 65 years (n = 88) | P |
---|---|---|---|
Participants with AEs | 18 (22.78) | 14 (15.91) | 0.260 |
Participants with local AE | 11 (13.92) | 8 (9.09) | 0.326 |
Participants with systemic AE | 10 (12.66) | 7 (7.95) | 0.316 |
Total AE | 30(40.0) | 21(23.9) | Â |
 Immediate unsolicited AE | 0 (0.00) | 1 (1.14) |  |
 Unsolicited AE | 2 (2.53) | 0 (0.00) |  |
 Solicited AE | 28(35.4) | 20(22.7) |  |
Local AE | 15(19.0) | 11(12.5) | Â |
 Redness | 3 (3.80) | 2 (2.27) |  |
 Swelling | 1 (1.27) | 2 (2.27) |  |
 Pain | 8 (10.13) | 5 (5.68) |  |
 Rash | 1 (1.27) | 0 (0.00) |  |
 Itch | 2 (2.53) | 1 (1.14) |  |
 Induration | 0 (0.00) | 1 (1.14) |  |
Systemic AE | 15(19.0) | 10(11.4) | Â |
 Fever | 5 (6.33) | 4 (4.55) |  |
 Myalgia | 4 (5.06) | 1 (1.14) |  |
 Fatigue | 3 (3.80) | 3 (3.41) |  |
 Headache | 2 (2.53) | 1 (1.14) |  |
 Cough | 0 (0.00) | 1 (1.14) |  |
 Nausea & Vomiting | 1 (1.27) | 0 (0.00) |  |
SAE | 0 (0.00) | 0 (0.00) | Â |
MAE | 0 (0.00) | 0 (0.00) | Â |