Table 1.

VE against 1-year persistence of different combinations of HPV types

HPV typeArmATP analysisaITT analysisb
Women in ATP cohort, NWomen with events, nRate per 100 women, n (95% CI)Rate reduction/100 women, n (95% CI)Efficacy, % (95% CI)Women in ITT cohort, NWomen with events, nRate per 100 women, n (95%CI)Rate reduction/100 women, n (95%CI)VE, % (95% CI)
HPV16,18Vaccine
Control
2,635
2,677
8
89
0.3 (0.1–0.6)
3.3 (2.7–4.1)
3.0 (2.5–3.3)90.9c (82.0–95.9)3,727
3,739
153
301
4.1 (3.5–4.8)
8.1 (7.2–9.0)
3.9 (2. 9–5.0)49.0d (38.1–58.1)
HPV31, 33, 45Vaccine
Control
2,642
2,695
37
68
1.4 (1.0–1.9)
2.5 (2.0–3.2)
1.1 (0.4–1.8)44.5 (17.5–63.1)3,727
3,739
150
178
4.0 (3.4–4.7)
4.8 (4.1–5.5)
0.7 (−0.2 to 1.7)15.5 (−5.0 to 32.0)
Other oncogenic typesVaccine
Control
2,643
2,697
230
207
8.7 (7.7–9.8)
7.7 (6.7–8.7)
−1.0 (−2.6 to 0.5)−13.4 (−36.9 to 6.0)3,727
3,739
559
553
15.0 (13.9–16.2)
14.8 (13.7–16.0)
−0.2 (−2.0 to 1.5)−1.4 (−14.1 to 9.8)
Any oncogenic typeVaccine
Control
2,643
2,697
267
311
10.1 (9.0–11.3)
11.5 (10.4–12.8)
1.4 (−0.3 to 3.2)12.4 (−3.2 to 25.6)3,727
3,739
764
864
20.5 (19.2–21.8)
23.1 (21.8–24.5)
2.6 (0.5–4.7)11.3 (2.2–19.5)
  • 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 (loop electrosurgical excision procedure [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.

  • c One-sided P-value for test of VE equals 0 against the alternative that VE is greater than 0 is less than 10−17.

  • d One-sided P-value for test of VE equals 0 against the alternative that VE is greater than 0 is less than 10−11.