TABLE 4

Incidence of Cervical Cytology Abnormalities in Girls Vaccinated With the 4vHPV Vaccine

Protocol 018 LTFU StudyProtocol 007, 013, 015aProtocol 019a Study
Girls Aged 9–15 yFemale Subjects Aged 16–25 yFemale Subjects Aged 24–45 y
Rate per 100 Person-years (95% CI)Rate per 100 Person-years (95% CI)Rate per 100 Person-years (95% CI)
EVG (N = 614)CVG (N = 262)N = 9075N = 1910
ASCUS HR-HPV–positive, LSIL, or worse10.4 (8.2–13.1)17.6 (13.3–22.8)10.6 (10.2–11.0)4.2 (3.7–4.7)
ASCUS HR-HPV–positive4.5 (3.2–6.2)7.1 (4.8–10.2)2.9 (2.8–3.1)2.0 (1.7–2.4)
LSIL7.9 (6.0–10.2)13.3 (9.7–17.7)8.2 (7.9–8.6)2.8 (2.4–3.3)
ASC-H0.3 (0.1–0.9)0.2 (0.0–1.2)0.6 (0.5–0.7)0.2 (0.1–0.3)
HSIL0.1 (0.0–0.6)0.0 (0.0–0.8)0.5 (0.4–0.6)0.2 (0.1–0.3)
AGC0.0 (0.0–0.4)0.2 (0.0–1.2)<0.1 (0.0–0.1)<0.1 (0.0–0.1)
Adenocarcinoma0.0 (0.0–0.4)0.0 (0.0–0.8)0.0 (0.0–<0.1)<0.1 (0.0–0.1)
Squamous cell carcinoma0.0 (0.0–0.4)0.0 (0.0–0.8)0.0 (0.0–<0.1)0.0 (0.0–0.1)
  • AGC, atypical glandular cells; ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; ASCUS, atypical squamous cells of undetermined significance; HR, high-risk probe result; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; N, number of subjects in the indicated group who received at least 1 dose of the 4vHPV vaccine.

  • a Details of study protocols are included in Supplemental Table 6.