Table 1.
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) |
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.
ITT cohorts include all women randomized and vaccinated, regardless of prevalence of infection and follow-up visits.
One-sided P-value for test of VE equals 0 against the alternative that VE is greater than 0 is less than 10−17.
One-sided P-value for test of VE equals 0 against the alternative that VE is greater than 0 is less than 10−11.