Table 5.

ATP and ITT efficacy estimates against HPV16/18 by number of sexual partners at enrollment

Number of sex partnersArmATP 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, % (95% CI)
VirginVaccine
Control
566
615
1
17
0.2 (0.0–0.9)
2.8 (1.7–4.3)
2.6 (1.4–2.9)93.6 (64.8–99.7)773
819
4
21
0.5 (0.2–1.2)
2.6 (1.6–3.8)
2.0 (0.9–2.7)79.8 (44.9–94.1)
1 partnerVaccine
Control
904
915
3
27
0.3 (0.1–0.9)
3.0 (2.0–4.2)
2.6 (1.6–3.1)88.8 (66.5–97.3)1,237
1,256
40
83
3.2 (2.4–4.3)
6.6 (5.3–8.1)
3.4 (1.7–4.9)51.1 (28.9–66.7)
2 partnersVaccine
Control
544
519
1
17
0.2 (0.0–0.9)
3.3 (2.0–5.1)
3.1 (1.8–3.4)94.4 (69.1–99.7)777
753
38
81
4.9 (3.5–6.6)
10.8 (8.7–13.1)
5.9 (3.1–8.3)54.5 (33.5–69.3)
3+ partnersVaccine
Control
621
628
3
28
0.5 (0.1–1.3)
4.5 (3.0–6.3)
4.0 (2.5–4.7)89.2 (67.9–97.4)940
911
71
116
7.6 (6.0–9.4)
12.7 (10.7–15.0)
5.2 (2.3–7.9)40.7 (20.4–56.0)
  • 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.