Table 3.
VE against 1-year persistence with HPV16/18 stratified by age at enrollment
| Age | Arm | ATP analysisa | ITT analysisb | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 100 women, n (95% CI) |
Rate reduction/ 100 women, n (95% CI) |
VE, % (95% CI) |
||
| 18–19 y | Vaccine | 825 | 1 | 0.1 (0.0–0.6) | 2.9 (2.0–3.1) | 95.9 (78.5–99.8) | 1,193 | 28 | 2.3 (1.6–3.3) | 5.2 (3.6–6.6) | 68.9 (53.1–79.9) |
| Control | 870 | 26 | 3.0 (2.0–4.3) | 1,244 | 94 | 7.6 (6.2–9.1) | |||||
| 2 0–21 y | Vaccine | 659 | 3 | 0.5 (0.1–1.2) | 2.9 (1.6–3.6) | 86.6 (59.2–96.8) | 946 | 46 | 4.9 (3.6–6.4) | 3.6 (1.3–5.8) | 42.8 (17.9–60.6) |
| Control | 649 | 22 | 3.4 (2.2–5.0) | 905 | 77 | 8.5 (6.8–10.5) | |||||
| 22–23 y | Vaccine | 588 | 1 | 0.2 (0.0–0.8) | 3.8 (2.7–4.1) | 95.7 (77.4–99.8) | 818 | 36 | 4.4 (3.1–6.0) | 4.7 (2.2–6.9) | 51.5 (28.4–67.7) |
| Control | 625 | 25 | 4.0 (2.7–5.8) | 848 | 77 | 9.1 (7.3–11.2) | |||||
| 24–25 y | Vaccine | 563 | 3 | 0.5 (0.1–1.4) | 2.5 (1.0–3.3) | 82.2 (43.9–95.9) | 770 | 43 | 5.6 (4.1–7.4) | 1.6 (−1.0 to 4.0) | 21.8 (−16.9 to 47.9) |
| Control | 533 | 16 | 3.0 (1.8–4.7) | 742 | 53 | 7.1 (5.5–9.2) | |||||
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.