Table 3.

VE against 1-year persistence with HPV16/18 stratified by age at enrollment

AgeArmATP 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 100 women, n (95% CI)Rate reduction/100 women, n (95% CI)VE, % (95% CI)
18–19 yVaccine
Control
825
870
1
26
0.1 (0.0–0.6)
3.0 (2.0–4.3)
2.9 (2.0–3.1)95.9 (78.5–99.8)1,193
1,244
28
94
2.3 (1.6–3.3)
7.6 (6.2–9.1)
5.2 (3.6–6.6)68.9 (53.1–79.9)
20–21 yVaccine
Control
659
649
3
22
0.5 (0.1–1.2)
3.4 (2.2–5.0)
2.9 (1.6–3.6)86.6 (59.2–96.8)946
905
46
77
4.9 (3.6–6.4)
8.5 (6.8–10.5)
3.6 (1.3–5.8)42.8 (17.9–60.6)
22–23 yVaccine
Control
588
625
1
25
0.2 (0.0–0.8)
4.0 (2.7–5.8)
3.8 (2.7–4.1)95.7 (77.4–99.8)818
848
36
77
4.4 (3.1–6.0)
9.1 (7.3–11.2)
4.7 (2.2–6.9)51.5 (28.4–67.7)
24–25 yVaccine
Control
563
533
3
16
0.5 (0.1–1.4)
3.0 (1.8–4.7)
2.5 (1.0–3.3)82.2 (43.9–95.9)770
742
43
53
5.6 (4.1–7.4)
7.1 (5.5–9.2)
1.6 (−1.0 to 4.0)21.8 (−16.9 to 47.9
  • 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.