Table 3.
AE summary (‘all participants as treated’ population)
| 9vHPV vaccine (N = 200) | |
|---|---|
| Participants with ≥1 AE, n (%)a | 101 (50.5) |
| Injection-site AEs, n (%)b | 90 (45.0) |
| Injection-site pain | 89 (44.5) |
| Mild | 86 (43.0) |
| Moderate | 3 (1.5) |
| Injection-site swelling | 11 (5.5) |
| Mild (0 to 2.5 cm) | 9 (4.5) |
| Moderate (2.5 to 5.0 cm) | 1 (0.5) |
| Severe (>5.0 cm) | 1 (0.5) |
| Injection-site erythema | 4 (2.0) |
| Mild (0 to 2.5 cm) | 4 (2.0) |
| Systemic AEs, n (%)c | 34 (17.0) |
| Headache | 7 (3.5) |
| Dizziness | 5 (2.5) |
| Nasopharyngitis | 5 (2.5) |
| Vaccine-relatedd systemic AEs, n (%)c | 2 (1.0) |
| SAEs, n (%)a | 1 (0.5) |
| Vaccine-relatedd SAEs, n (%) | 0 (0.0) |
| Deaths, n (%) | 0 (0.0) |
| Participants who discontinuede due to an AE,a n (%) | 0 (0.0) |
| Maximum temperature (oral) <37.8°Cb | 200 (100) |
N = number of participants who had ≥1 dose of the 9vHPV vaccine and had ≥1 follow-up visit for an AE.
aAt any time during the study.
bDays 1 to 5 following any vaccination.
cDays 1 to 15 following any vaccination.
dAs determined by the reporting investigator.
eStudy vaccination withdrawn.
Injection-site and systemic AEs shown are those with a frequency ≥2%. Participants were counted once for each applicable AE.
9vHPV, nine-valent human papillomavirus; AE, adverse event; SAE, serious adverse event.