Table 8. Comparison of adverse events between investigational product and control.
| Description | 0118S (n=131) | 0218S (n=133) | 0318S (n=127) | 0318 (n=130) | p-value | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| nEv | nSj (%) | nEv | nSj (%) | nEv | nSj (%) | nEv | nSj (%) | ||||
| After 1st immunization | |||||||||||
| Any immediate reaction | |||||||||||
| Any immediate local reaction | 67 | 47 (35.34) | 60 | 43 (32.09) | 31 | 27 (20.93) | 52 | 43 (33.33) | 0.061 | ||
| Any immediate systemic event | 13 | 10 (7.52) | 13 | 10 (7.46) | 6 | 5 (3.88) | 9 | 8 (6.06) | 0.603 | ||
| Any delayed adverse event (31 min–72 hr) | |||||||||||
| Any delayed local reaction | 14 | 14 (10.53) | 23 | 20 (14.92) | 21 | 17 (13.18) | 23 | 15 (11.36) | 0.699 | ||
| Any delayed systemic event | 7 | 6 (4.51) | 13 | 10 (7.46) | 20 | 15 (11.63) | 20 | 17 (12.88) | 0,069 | ||
| Any delayed adverse event (4–28 day) | |||||||||||
| Any delayed local reaction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.000 | ||
| Any delayed systemic event | 16 | 14 (10.53) | 18 | 17 (12.69) | 13 | 9 (6.98) | 22 | 19 (14.39) | 0.280 | ||
| After 2nd immunization | |||||||||||
| Any immediate reaction | |||||||||||
| Any immediate local reaction | 35 | 32 (24.06) | 47 | 42 (31.58) | 41 | 36 (28.12) | 52 | 46 (35.11) | 0.258 | ||
| Any immediate systemic event | 7 | 6 (4.51) | 16 | 12 (9.02) | 17 | 15 (11.72) | 13 | 11 (8,2) | 0.208 | ||
| Any delayed adverse event (31 min–72 hr) | |||||||||||
| Any delayed local reaction | 13 | 13 (9.77) | 36 | 26 (19.55) | 28 | 12 (9.37) | 31 | 19 (14.5) | 0.053 | ||
| Any delayed systemic event | 17 | 12 (9.02) | 18 | 12 (9.02) | 12 | 12 (9.37) | 21 | 13 (9.92) | 0.993 | ||
| Any delayed adverse event (4–28 day) | |||||||||||
| Any delayed local reaction | 0 | 0 | 1 | 1 (0.75) | 2 | 2 (1.56) | 3 | 1 (1.76) | 0.431 | ||
| Any delayed systemic event | 15 | 13 (9.77) | 24 | 18 (13.53) | 35 | 24 (18.75) | 41 | 32 (24.43) | 0.009 | ||
| After 3rd immunization | |||||||||||
| Any immediate reaction | |||||||||||
| Any immediate local reaction | 33 | 30 (22.9) | 43 | 33 (24.81) | 34 | 32 (25.2) | 48 | 38 (29.23) | 0.693 | ||
| Any immediate systemic event | 6 | 5 (3.82) | 1 | 1 (0.75) | 6 | 5 (3.94) | 2 | 2 (1.54) | 0.249 | ||
| Any delayed adverse event (31 min–72 hr) | |||||||||||
| Any delayed local reaction | 29 | 19 (14.5) | 30 | 23 (17.29) | 28 | 16 (12.6) | 36 | 18 (13.85) | 0.748 | ||
| Any delayed systemic event | 6 | 5 (3.82) | 10 | 8 (6.01) | 12 | 11 (8.66) | 16 | 11 (8.46) | 0.353 | ||
| Any delayed adverse event (4–28 day) | |||||||||||
| Any delayed local reaction | 1 | 1 (0.76) | 0 | 0 | 2 | 2 (1.57) | 1 | 1 (0.77) | 0.386 | ||
| Any delayed systemic event | 25 | 17 (12.98) | 18 | 16 (12.03) | 18 | 17 (13.39) | 28 | 21 (16.15) | 0.796 | ||
nEv, number of event; nSj, number of subject.