Table 5.
ATP and ITT efficacy estimates against HPV16/18 by number of sexual partners at enrollment
| Number of sex partners |
Arm | ATP analysisa | ITT analysis b | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Women, N | Women with events, n |
Rate per 100 women, n (95% CI) |
Rate reduction/ 100 women, n (95% CI) |
VE, % (95% CI) |
Women, N | Women with events, n |
Rate per 100 women, n (95% CI) |
Rate reduction/ 100 women, n (95% CI) |
VE, % (95% CI) |
||
| Virgin | Vaccine | 566 | 1 | 0.2 (0.0–0.9) | 2.6 (1.4–2.9) | 93.6 (64.8–99.7) | 773 | 4 | 0.5 (0.2–1.2) | 2.0 (0.9–2.7) | 79.8 (44.9–94.1) |
| Control | 615 | 17 | 2.8 (1.7–4.3) | 819 | 21 | 2.6 (1.6–3.8) | |||||
| 1 partner | Vaccine | 904 | 3 | 0.3 (0.1–0.9) | 2.6 (1.6–3.1) | 88.8 (66.5–97.3) | 1,237 | 40 | 3.2 (2.4–4.3) | 3.4 (1.7–4.9) | 51.1 (28.9–66.7) |
| Control | 915 | 27 | 3.0 (2.0–4.2) | 1.256 | 83 | 6.6 (5.3–8.1) | |||||
| 2 partners | Vaccine | 544 | 1 | 0.2 (0.0–0.9) | 3.1 (1.8–3.4) | 94.4 (69.1–99.7) | 777 | 38 | 4.9 (3.5–6.6) | 5.9 (3.1–8.3) | 54.5 (33.5–69.3) |
| Control | 519 | 17 | 3.3 (2.0–5.1) | 753 | 81 | 10.8 (8.7–13.1) | |||||
| 3+ partners | Vaccine | 621 | 3 | 0.5 (0.1–1.3) | 4.0 (2.5–4.7) | 89.2 (67.9–97.4) | 940 | 71 | 7.6 (6.0–9.4) | 5.2 (2.3–7.9) | 40.7 (20.4–56.0) |
| Control | 628 | 28 | 4.5 (3.0–6.3) | 911 | 116 | 12.7 (10.7–15.0) | |||||
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.