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. Author manuscript; available in PMC: 2012 Oct 1.
Published in final edited form as: Cancer Discov. 2011 Sep 9;1(5):408–419. doi: 10.1158/2159-8290.CD-11-0131

Table 1.

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

HPV type ATP analysisa ITT analysisb


Arm Women
in ATP
cohort, N
Women
with
events, n
Rate per 100
women, n
(95% CI)
Rate reduction/
100 women,
n (95% CI)
Efficacy,
% (95% CI)
Women
in ITT
cohort, N
Women
with
events, n
Rate per
100 women,
n (95%CI)
Rate reduction/
100 women,
n (95%CI)
VE, %
(95% CI)
H PV16,18 Vaccine 2,635 8 0.3 (0.1–0.6) 3.0 (2.5–3.3) 90.9c (82.0–95.9) 3,727 153 4.1 (3.5–4.8) 3.9 (2. 9–5.0) 49.0d (38.1–58.1)
Control 2,677 89 3.3 (27–4.1) 3,739 301 8.1 (7.2–9.0)

HPV31, 33, 45 Vaccine 2,642 37 1.4 (1.0–1.9) 1.1 (0.4–1.8) 44.5 (17.5–63.1) 3,727 150 4.0 (3.4–4.7) 0.7 (−0.2 to 1.7) 15.5 (−5.0 to 32.0)
Control 2,695 68 2.5 (2.0–3.2) 3,739 178 4.8 (4.1–5.5)

Other Vaccine 2,643 230 8.7 (7.7–9.8) −1.0 (−2.6 to 0.5) −13.4 (−36.9 to 6.0) 3,727 559 15.0 (13.9–16.2) −0.2 (−2.0 to 1.5) −1.4 (−14.1 to 9.8)
oncogenic types Control 2,697 207 7.7 (6.7–8.7) 3,739 553 14.8 (13.7–16.0)

Any Vaccine 2,643 267 10.1 (9.0–11.3) 1.4 (−0.3 to 3.2) 12.4 (−3.2 to 25.6) 3,727 764 20.5 (19.2–21.8) 2.6 (0.5–4.7) 11.3 (2.2–19.5)
oncogenic type Control 2,697 311 11.5 (10.4–12.8) 3,739 864 23.1 (21.8–24.5)
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.