Table 4.

ATP and ITT efficacy estimates against HPV16/18 by time since first sexual intercourse at enrollment

Time since first sexArmATP 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)
<2 yVaccine
Control
227
244
1
12
0.4 (0.0–2.2)
4.9 (2.7–8.2)
4.5 (1.7–5.3)91.0 (48.3–99.6)352
349
12
38
3.4 (1.9–5.7)
10.9 (7.9–14.5)
7.5 (3.7–10.4)68.7 (41.2–84.3)
2 yVaccine
Control
233
221
0
9
0.0 (0.0–1.3)
4.1 (2.0–7.3)
4.1 (1.8–4.1)100.0 (62.5–100.0)335
325
19
42
5.7 (3.6–8.6)
12.9 (9.6–16.9)
7.3 (2.7–11.2)56.1 (25.2–75.0)
3 yVaccine
Control
279
256
0
13
0.0 (0.0–1.1)
5.1 (2.9–8.3)
5.1 (3.1–5.1)100.0 (76.2–100.0)395
394
19
42
4.8 (3.0–7.3)
10.7 (7.9–14.0)
5.8 (2.0–9.1)54.9 (23.1–74.3)
4+ yVaccine
Control
1,330
1,341
6
38
0.5 (0.2–0.9)
2.8 (2.0–3.8)
2.4 (1.6–2.9)84.1 (64.2–93.9)1,872
1,852
99
158
5.3 (4.3–6.4)
8.5 (7.3–9.9)
3.2 (1.6–4.8)38.0 (20.4–51.9)
  • 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.