Table 2.
Incidence of HPV6/11/16/18/31/33/45/52/58-related persistent infection and disease in vaccinated participants (PPE population).
| Females (N = 971) |
Males (N = 301) |
|||||
|---|---|---|---|---|---|---|
| Cases/n | Person-years follow-upa | Rate per 10,000 person-years (95% CI) | Cases/n | Person-years follow-upa | Rate per 10,000 person-years (95% CI) | |
| HPV6/11/16/18/31/33/45/52/58-related 6-month persistent infectionb or diseasec | 14/856 | 2843.8 | 49.2 (26.9–82.6) | 3/251 | 803.2 | 37.3 (7.7–109.1) |
| HPV6/11/16/18/31/33/45/52/58-related 6-month persistent infectionb | 14/856 | 2843.8 | 49.2 (26.9–82.6) | 3/251 | 803.2 | 37.3 (7.7–109.1) |
| By HPV type | ||||||
| HPV6/11/16/18 | 13/854 | 2842.2 | 45.7 (24.4–78.2) | 1/251 | 808.4 | 12.4 (0.3–68.9) |
| HPV6 | 1/831 | 2784.8 | 3.6 (0.1–20.0) | 0/245 | 790.6 | 0.0 (0.0–46.7) |
| HPV11 | 0/832 | 2789.2 | 0.0 (0.0–13.2) | 1/245 | 790.2 | 12.7 (0.3–70.5) |
| HPV16 | 11/843 | 2805.2 | 39.2 (19.6–70.2) | 0/250 | 805.2 | 0.0 (0.0–45.8) |
| HPV18 | 1/851 | 2847.1 | 3.5 (0.1–19.6) | 0/249 | 800.0 | 0.0 (0.0–46.1) |
| HPV31/33/45/52/58 | 1/856 | 2862.3 | 3.5 (0.1–19.5) | 2/251 | 803.6 | 24.9 (3.0–89.9) |
| HPV31 | 0/839 | 2804.7 | 0.0 (0.0–13.2) | 0/249 | 805.0 | 0.0 (0.0–45.8) |
| HPV33 | 1/850 | 2847.6 | 3.5 (0.1–19.6) | 0/249 | 806.3 | 0.0 (0.0–45.7) |
| HPV45 | 0/855 | 2863.7 | 0.0 (0.0–12.9) | 1/251 | 805.4 | 12.4 (0.3–69.2) |
| HPV52 | 0/854 | 2859.0 | 0.0 (0.0–12.9) | 2/251 | 803.6 | 24.9 (3.0–89.9) |
| HPV58 | 0/847 | 2837.8 | 0.0 (0.0–13.0) | 0/249 | 805.4 | 0.0 (0.0–45.8) |
| HPV6/11/16/18/31/33/45/52/58-related 12-month persistent infectiond | 7/856 | 2851.4 | 24.5 (9.9–50.6) | 1/251 | 807.4 | 12.4 (0.3–69.0) |
| By HPV type | ||||||
| HPV6/11/16/18 | 6/854 | 2849.7 | 21.1 (7.7–45.8) | 0/251 | 808.8 | 0.0 (0.0–45.6) |
| HPV6 | 1/832 | 2787.8 | 3.6 (0.1–20.0) | 0/245 | 790.6 | 0.0 (0.0–46.7) |
| HPV11 | 0/832 | 2789.2 | 0.0 (0.0–13.2) | 0/245 | 790.6 | 0.0 (0.0–46.7) |
| HPV16 | 4/844 | 2817.2 | 14.2 (3.9–36.4) | 0/250 | 805.2 | 0.0 (0.0–45.8) |
| HPV18 | 1/851 | 2847.1 | 3.5 (0.1–19.6) | 0/249 | 800.0 | 0.0 (0.0–46.1) |
| HPV31/33/45/52/58 | 1/856 | 2862.3 | 3.5 (0.1–19.5) | 1/251 | 807.4 | 12.4 (0.3–69.0) |
| HPV31 | 0/839 | 2804.7 | 0.0 (0.0–13.2) | 0/249 | 805.0 | 0.0 (0.0–45.8) |
| HPV33 | 1/850 | 2847.6 | 3.5 (0.1–19.6) | 0/249 | 806.3 | 0.0 (0.0–45.7) |
| HPV45 | 0/855 | 2863.7 | 0.0 (0.0–12.9) | 0/251 | 808.8 | 0.0 (0.0–45.6) |
| HPV52 | 0/854 | 2859.0 | 0.0 (0.0–12.9) | 1/251 | 807.4 | 12.4 (0.3–69.0) |
| HPV58 | 0/847 | 2837.8 | 0.0 (0.0–13.0) | 0/249 | 805.4 | 0.0 (0.0–45.8) |
| HPV6/11/16/18/31/33/45/52/58-related diseasec | 1/856e | 2865.0 | 3.5 (0.1–19.4) | 0/251 | 808.8 | 0.0 (0.0–45.6) |
| CIN1f | 1/856 | 2865.0 | 3.5 (0.1–19.4) | – | – | – |
| CIN2 or CIN3f | 0/856 | 2865.9 | 0.0 (0.0–12.9) | – | – | – |
| AISf | 0/856 | 2865.9 | 0.0 (0.0–12.9) | – | – | – |
| Cervical cancerf | 0/856 | 2865.9 | 0.0 (0.0–12.9) | – | – | – |
| Condyloma | 0/856 | 2865.9 | 0.0 (0.0–12.9) | 0/251 | 808.8 | 0.0 (0.0–45.6) |
| VIN1 or worsef | 0/856 | 2865.9 | 0.0 (0.0–12.9) | – | – | – |
| VaIN1 or worsef | 0/856 | 2865.9 | 0.0 (0.0–12.9) | – | – | – |
| PIN1 or worseg | – | – | – | 0/251 | 808.8 | 0.0 (0.0–45.6) |
Abbreviations: AIS = adenocarcinoma in situ; CI = confidence interval; CIN = cervical intraepithelial neoplasia; HPV = human papillomavirus; PCR = polymerase chain reaction; PIN = penile intraepithelial neoplasia; PPE = per-protocol effectiveness; VaIN = vaginal intraepithelial neoplasia; VIN = vulvar intraepithelial neoplasia.
For each participant, person-years of follow-up was calculated starting from the beginning of the LTFU study (i.e. month 42 visit) or the date when the participant reached age 16 years, whichever came later.
A case of 6-month persistent infection is a participant who is positive to ≥1 common gene for the same HPV type in the HPV6/11/16/18/31/33/45/52/58 PCR assay in two or more cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained at two or more consecutive visits at least 6 months (±1 month) apart.
In females, disease includes condyloma, CIN, AIS, VIN, VaIN, and cervical/vulvar/vaginal cancer; in males, this includes condyloma, PIN, and penile/perineal/perianal cancer.
A case of 12-month persistent infection is a participant who is positive to ≥1 common gene for the same HPV type in the HPV6/11/16/18/31/33/45/52/58 PCR assay in two or more cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained at three or more consecutive visits at least 6 months (±1 month) apart.
HPV16-related CIN1.
In female participants.
In male participants.