Table 6.

Rates of persistent infection with HPV16/18 and VE (ATP and ITT) against HPV16/18 by time since enrollment

Time since enrollmentArmATP analysisaITT analysisb
Women, NWomen with events, nRate per 100 women, n (95% CI)Rate reduction/100 women, n (95% CI)VE, % (95% CI)Women, NWomen with events, nRate per 100 women, n (95% CI)Rate reduction/100 women, n (95% CI)VE, n (95% CI)
10–22 moVaccine
Control
1,599
1,655
5
18
0.3 (0.1–0.7)
1.1 (0.7–1.7)
0.8 (0.2–1.2)71.2 (25.6–90.5)3,056
3,071
115
137
3.8 (3.1–4.5)
4.5 (3.8–5.2)
0.7 (–0.3 to 1.7)15.6 (–8.1 to 34.2)
22–34 moVaccine
Control
2,190
2,239
3
38
0.1 (0.0–0.4)
1.7 (1.2–2.3)
1.6 (1.1–1.8)91.9 (76.6–98.0)2,870
2,913
25
63
0.9 (0.6–1.3)
2.2 (1.7–2.7)
1.3 (0.7–1.8)59.7 (36.5–75.0)
34–46 moVaccine
Control
1,258
1,240
0
17
0.0 (0.0–0.2)
1.4 (0.8–2.1)
1.4 (0.9–1.4)100.0 (81.0–100.0)3,031
3,001
11
66
0.4 (0.2–0.6)
2.2 (1.7–2.8)
1.8 (1.4–2.2)83.5 (69.6–91.7)
46+ moVaccine
Control
973
1,011
0
16
0.0 (0.0–0.3)
1.6 (0.9–2.5)
1.6 (1.0–1.6)100.0 (78.6–100.0)2,101
2,083
2
35
0.1 (0.0–0.3)
1.7 (1.2–2.3)
1.6 (1.2–1.7)94.3 (80.1–99.1)
  • a The ATP cohort includes women who received all 3 doses within protocol-defined windows, complied with the protocol during the vaccination period, did not have a biopsy or treatment (LEEP) before the 6-month visit, and were HPV DNA negative (by PCR) for at least one of the HPV types in the end point at enrollment and at the 6-month visit.

  • b ITT cohorts include all women randomized and vaccinated, regardless of prevalence of infection and follow-up visits.