Table 7.
AEs in Asian Girls and Boys (Aged 9–15 Years) in Study 002 by Country
| Event | 9vHPV Vaccine | ||||
|---|---|---|---|---|---|
| India (N = 194) | South Korea (N = 129) | Taiwan (N = 139) | Thailand (N = 140) | Total (N = 602) | |
| n (%) | n (%) | n (%) | n (%) | n (%) | |
| Participants with 1 or more AEa | 127 (65.5) | 99 (76.7) | 104 (74.8) | 126 (90.0) | 456 (75.7) |
| Injection-site eventb | 121 (62.4) | 96 (74.4) | 99 (71.2) | 120 (85.7) | 436 (72.4) |
| Painc | 117 (60.3) | 91 (70.5) | 96 (69.1) | 118 (84.3) | 422 (70.1) |
| Mild | 62 (32.0) | 72 (55.8) | 77 (55.4) | 74 (52.9) | 285 (47.3) |
| Moderate | 46 (23.7) | 17 (13.2) | 17 (12.2) | 39 (27.9) | 119 (19.8) |
| Severe | 9 (4.6) | 2 (1.6) | 2 (1.4) | 5 (3.6) | 18 (3.0) |
| Swelling | 46 (23.7) | 26 (20.2) | 40 (28.8) | 35 (25.0) | 147 (24.4) |
| Mild: 0 to ≤2.5 cm | 35 (18.0) | 12 (9.3) | 29 (20.9) | 23 (16.4) | 99 (16.4) |
| Moderate: >2.5 cm to ≤5.0 cm | 8 (4.1) | 8 (6.2) | 8 (5.8) | 8 (5.7) | 32 (5.3) |
| Severe: >5.0 cm | 3 (1.5) | 6 (4.7) | 3 (2.2) | 4 (2.9) | 16 (2.7) |
| Erythema | 36 (18.6) | 34 (26.4) | 39 (28.1) | 13 (9.3) | 122 (20.3) |
| Mild: 0 to ≤2.5 cm | 31 (16.0) | 27 (20.9) | 33 (23.7) | 9 (6.4) | 100 (16.6) |
| Moderate: >2.5 cm to ≤5.0 cm | 4 (2.1) | 3 (2.3) | 4 (2.9) | 3 (2.1) | 14 (2.3) |
| Severe: >5.0 cm | 1 (0.5) | 4 (3.1) | 2 (1.4) | 1 (0.7) | 8 (1.3) |
| Pruritusc | 1 (0.5) | 11 (8.5) | 6 (4.3) | 1 (0.7) | 19 (3.2) |
| Mild | 1 (0.5) | 11 (8.5) | 3 (2.2) | 1 (0.7) | 16 (2.7) |
| Moderate | 0 | 0 | 3 (2.2) | 0 | 3 (0.5) |
| Severe | 0 | 0 | 0 | 0 | 0 |
| Edemad | 0 | 19 (14.7) | 0 | 0 | 19 (3.2) |
| Mild | 0 | 12 (9.3) | 0 | 0 | 12 (2.0) |
| Moderate | 0 | 4 (3.1) | 0 | 0 | 4 (0.7) |
| Severe | 0 | 3 (2.3) | 0 | 0 | 3 (0.5) |
| Systemic evente | 34 (17.5) | 35 (27.1) | 25 (18.0) | 69 (49.3) | 163 (27.1) |
| Any vaccine-related systemic event | 21 (10.8) | 6 (4.7) | 6 (4.3) | 37 (26.4) | 70 (11.6) |
| Headache | 1 (0.5) | 2 (1.6) | 2 (1.4) | 15 (10.7) | 20 (3.3) |
| Pyrexia | 19 (9.8) | 0 | 3 (2.2) | 19 (13.6) | 41 (6.8) |
| Serious event | 0 | 2 (1.6) | 0 | 0 | 2 (0.3) |
| Vaccine-related event | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 |
| Discontinuation due to AEf | 0 | 0 | 0 | 0 | 0 |
| Participants with temperature data (N) | 194 | 129 | 139 | 140 | 602 |
| Maximum temperatures (oral)g | |||||
| ≥37.8°C | 20 (10.3) | 2 (1.6) | 4 (2.9) | 24 (17.1) | 50 (8.3) |
| ≥38.9°C | 0 | 0 | 1 (0.7) | 5 (3.6) | 6 (1.0) |
Every participant is counted a single time for each applicable specific AE.
Abbreviations: 9vHPV, 9-valent human papillomavirus; AE, adverse event.
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.
dInjection-site edema was reported in 19 girls and boys from a single study site in South Korea in Study 002. Edema was not reported as an AE at other study sites in South Korea or other countries; moreover, this particular study site did not report any event of injection-site swelling, even though this would have been anticipated because injection-site swelling is one of the most common AEs following vaccination. Reports of injection-site AE of edema at this study site may be due to language-related misinterpretation (ie, even though there are 2 distinct Korean words for swelling and edema, respectively, there is also another word for both swelling and edema).
eSystemic 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.
fDiscontinuation due to AE was reported within 1 to 15 days after any vaccination.
gTemperatures were recorded within 1 to 5 days after any vaccination.