Table 6.
AEs in Asian Young Women (Aged 16–26 Years) from Study 001 by Vaccination Group and Country
| Event | 9vHPV Vaccine | qHPV Vaccine | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Hong Kong and Taiwan (N = 345) | Japan (N = 127) | South Korea (N = 152) | Thailand (N = 232) | Total (N = 856) | Hong Kong and Taiwan (N = 346) | Japan (N = 127) | South Korea (N = 150) | Thailand (N = 231) | Total (N = 854) | |
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
| Participants with 1 or more AEa | 304 (88.1) | 108 (85.0) | 137 (90.1) | 211 (90.9) | 760 (88.8) | 297 (85.8) | 103 (81.1) | 130 (86.7) | 206 (89.2) | 736 (86.2) |
| Injection-site eventb | 294 (85.2) | 104 (81.9) | 133 (87.5) | 201 (86.6) | 732 (85.5) | 269 (77.7) | 101 (79.5) | 123 (82.0) | 192 (83.1) | 685 (80.2) |
| Painc | 286 (82.9) | 104 (81.9) | 131 (86.2) | 199 (85.8) | 720 (84.1) | 260 (75.1) | 100 (78.7) | 119 (79.3) | 189 (81.8) | 668 (78.2) |
| Mild | 216 (62.6) | 63 (49.6) | 76 (50.0) | 103 (44.4) | 458 (53.5) | 217 (62.7) | 76 (59.8) | 86 (57.3) | 93 (40.3) | 472 (55.3) |
| Moderate | 68 (19.7) | 41 (32.3) | 42 (27.6) | 86 (37.1) | 237 (27.7) | 37 (10.7) | 23 (18.1) | 27 (18.0) | 91 (39.4) | 178 (20.8) |
| Severe | 2 (0.6) | 0 | 13 (8.6) | 10 (4.3) | 25 (2.9) | 6 (1.7) | 1 (0.8) | 6 (4.0) | 5 (2.2) | 18 (2.1) |
| Swelling | 160 (46.4) | 57 (44.9) | 79 (52.0) | 71 (30.6) | 367 (42.9) | 99 (28.6) | 53 (41.7) | 53 (35.3) | 63 (27.3) | 268 (31.4) |
| Mild: 0 to ≤2.5 cm | 121 (35.1) | 36 (28.3) | 57 (37.5) | 51 (22.0) | 265 (31.0) | 84 (24.3) | 46 (36.2) | 43 (28.7) | 50 (21.6) | 223 (26.1) |
| Moderate: >2.5 cm to ≤5.0 cm | 27 (7.8) | 14 (11.0) | 11 (7.2) | 15 (6.5) | 67 (7.8) | 12 (3.5) | 5 (3.9) | 6 (4.0) | 11 (4.8) | 34 (4.0) |
| Severe: >5.0 cm | 11 (3.2) | 7 (5.5) | 11 (7.2) | 5 (2.2) | 34 (4.0) | 3 (0.9) | 2 (1.6) | 4 (2.7) | 2 (0.9) | 11 (1.3) |
| Unknown | 1 (0.3) | 0 | 0 | 0 | 1 (0.1) | 0 | 0 | 0 | 0 | 0 |
| Erythema | 126 (36.5) | 51 (40.2) | 59 (38.8) | 26 (11.2) | 262 (30.6) | 88 (25.4) | 48 (37.8) | 36 (24.0) | 15 (6.5) | 187 (21.9) |
| Mild: 0 to ≤2.5 cm | 108 (31.3) | 35 (27.6) | 42 (27.6) | 20 (8.6) | 205 (23.9) | 78 (22.5) | 44 (34.6) | 29 (19.3) | 13 (5.6) | 164 (19.2) |
| Moderate: >2.5 cm to ≤5.0 cm | 13 (3.8) | 11 (8.7) | 10 (6.6) | 5 (2.2) | 39 (4.6) | 9 (2.6) | 3 (2.4) | 5 (3.3) | 2 (0.9) | 19 (2.2) |
| Severe: >5.0 cm | 5 (1.4) | 5 (3.9) | 7 (4.6) | 1 (0.4) | 18 (2.1) | 1 (0.3) | 1 (0.8) | 2 (1.3) | 0 | 4 (0.5) |
| Pruritusc | 16 (4.6) | 12 (9.4) | 15 (9.9) | 10 (4.3) | 53 (6.2) | 4 (1.2) | 14 (11.0) | 7 (4.7) | 7 (3.0) | 32 (3.7) |
| Mild | 13 (3.8) | 11 (8.7) | 12 (7.9) | 7 (3.0) | 43 (5.0) | 4 (1.2) | 14 (11.0) | 5 (3.3) | 5 (2.2) | 28 (3.3) |
| Moderate | 3 (0.9) | 1 (0.8) | 2 (1.3) | 3 (1.3) | 9 (1.1) | 0 | 0 | 2 (1.3) | 2 (0.9) | 4 (0.5) |
| Severe | 0 | 0 | 1 (0.7) | 0 | 1 (0.1) | 0 | 0 | 0 | 0 | 0 |
| Systemic eventd | 136 (39.4) | 41 (32.3) | 70 (46.1) | 128 (55.2) | 375 (43.8) | 141 (40.8) | 38 (29.9) | 72 (48.0) | 139 (60.2) | 390 (45.7) |
| Any vaccine-related systemic event | 65 (18.8) | 15 (11.8) | 19 (12.5) | 98 (42.2) | 197 (23.0) | 48 (13.9) | 8 (6.3) | 19 (12.7) | 93 (40.3) | 168 (19.7) |
| Headache | 10 (2.9) | 5 (3.9) | 4 (2.6) | 40 (17.2) | 59 (6.9) | 9 (2.6) | 4 (3.1) | 3 (2.0) | 41 (17.7) | 57 (6.7) |
| Pyrexia | 9 (2.6) | 4 (3.1) | 2 (1.3) | 38 (16.4) | 53 (6.2) | 6 (1.7) | 0 | 1 (0.7) | 35 (15.2) | 42 (4.9) |
| Serious event | 2 (0.6) | 1 (0.8) | 1 (0.7) | 2 (0.9) | 6 (0.7) | 2 (0.6) | 2 (1.6) | 1 (0.7) | 2 (0.9) | 7 (0.8) |
| Vaccine-related event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinuation due to AEe | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) | 0 | 0 | 1 (0.7) | 0 | 1 (0.1) |
| Vaccine-related event | 0 | 0 | 0 | 1 (0.4) | 1 (0.1) | 0 | 0 | 1 (0.7) | 0 | 1 (0.1) |
| Serious event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious vaccine-related event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Participants with temperature data (N) | 344 | 127 | 148 | 231 | 850 | 346 | 126 | 148 | 231 | 851 |
| Maximum temperatures (oral)f | ||||||||||
| ≥37.8°C | 13 (3.8) | 4 (3.1) | 2 (1.4) | 38 (16.5) | 57 (6.7) | 12 (3.5) | 1 (0.8) | 3 (2.0) | 38 (16.5) | 54 (6.3) |
| ≥38.9°C | 1 (0.3) | 0 | 0 | 8 (3.5) | 9 (1.1) | 0 | 0 | 0 | 4 (1.7) | 4 (0.5) |
Every participant is counted a single time for each applicable specific AE.
Abbreviations: 9vHPV, 9-valent human papillomavirus; AE, adverse event; qHPV, quadrivalent human papillomavirus.
N = number of participants who underwent randomization, received at least 1 dose of vaccine, and had at least 1 follow-up visit related to the AE. n = number of participants contributing to the analysis.
aAEs that were reported within 1 to 15 days after any vaccination.
bInjection-site events were AEs that were reported within 1 to 5 days after any vaccination. A specific AE appears on this table only if its incidence in 1 or more of the columns is ≥5% incidence after rounding.
cIntensities of pain and itching were defined as: mild if there was an awareness of the sign or symptom but it did not interfere with usual activities; as moderate if there was enough discomfort to cause interference with usual activity; and as severe if the pain or discomfort was incapacitating, rendering the participant unable to work or carry out usual activities.
dSystemic events were AEs that were reported within 1 to 15 days after any vaccination. A specific AE appears on this table only if its incidence in 1 or more of the columns is ≥5% incidence after rounding.
eDiscontinuation due to AE was reported within 1 to 15 days after any vaccination.
fTemperatures were recorded within 1 to 5 days after any vaccination.