Table 4.
Severity of major adverse reaction in vaccine and placebo groups.
| Vaccine (N = 6000) n (%) |
Placebo (N = 6000) n (%) |
|||||
|---|---|---|---|---|---|---|
| Mild | Moderate | Severe | Mild | Moderate | Severe | |
| AR D28 | 1103 (18.38) | 1021 (17.02) | 71 (1.18) | 841 (14.02) | 686 (11.43) | 56 (0.93) |
| Solicited AR D7 | 1085 (18.08) | 1007 (16.78) | 69 (1.15) | 826 (13.77) | 672(11.20) | 56 (0.93) |
| Systemic AR D7 | 1012 (16.87) | 943 (15.72) | 67 (1.12) | 772 (12.87) | 663 (11.05) | 56 (0.93) |
| Fever | 811 (13.52) | 796 (13.27) | 61 (1.02) | 559 (9.32) | 526 (8.77) | 50 (0.83) |
| Diarrhea | 157 (2.62) | 60 (1.00) | 2 (0.03) | 161 (2.68) | 64 (1.07) | 3 (0.05) |
| ANV | 290 (4.83) | 84 (1.40) | 2 (0.03) | 220 (3.67) | 84 (1.40) | 1 (0.02) |
| IDF | 176 (2.93) | 115 (1.92) | 2 (0.03) | 143 (2.38) | 81 (1.35) | 3 (0.05) |
| Allergy | 64 (1.07) | 31 (0.52) | 1 (0.02) | 46 (0.77) | 19 (0.32) | 0 (0.00) |
| Local AR D7 | 446 (7.43) | 157 (2.62) | 2 (0.03) | 171 (2.85) | 16 (0.27) | 0 (0.00) |
| Pain | 172 (2.87) | 55 (0.92) | 1 (0.02) | 80 (1.33) | 7 (0.12) | 0 (0.00) |
| Redness | 97 (1.62) | 39 (0.65) | 1 (0.02) | 33 (0.55) | 1 (0.02) | 0 (0.00) |
| Pruritus | 51 (0.85) | 8 (0.13) | 0 (0.00) | 23 (0.38) | 7 (0.12) | 0 (0.00) |
| Swelling | 77 (1.28) | 36 (0.60) | 0 (0.00) | 24 (0.40) | 1 (0.02) | 0 (0.00) |
| Induration | 49 (0.82) | 19 (0.32) | 0 (0.00) | 11 (0.18) | 0 (0.00) | 0 (0.00) |
| Unsolicited AR D28 | 106 (1.77) | 49 (0.82) | 1 (0.02) | 83 (1.38) | 43 (0.72) | 0 (0.00) |
| Cold/RTI | 103 (1.72) | 48 (0.80) | 1 (0.02) | 82 (1.37) | 43 (0.72) | 0 (0.00) |
N: the number of participants; n: the number of participants with major adverse reaction.
RTI: respiratory tract infection; ANV: anorexia/nausea/vomiting; IDF: irritability/drowsiness/fatigue.