TABLE 4

Vaccine Effectiveness in Preventing HPV6/11/16/18-Related Persistent Infection or Disease, ITT Populations

EndpointEVGCVG
nNo. of casesRatea95% CInNo. of casesRatea95% CI
Females
 HPV6/11/16 or 18-related persistent infection or disease25620.30–1.112661.80.7–4.0
  HPV6-related256000–0.5126000–1.1
  HPV11-related256000–0.5126000–1.1
  HPV16-related25620.30–1.112620.60.1–2.1
  HPV18-related256000–0.512641.20.3–3.1
 HPV6/11/16 or 18-related persistent infection24020.30–1.212162.00.7–4.4
  HPV6-related240000–0.6121000–1.2
  HPV11-related240000–0.6121000–1.2
  HPV16-related24020.30–1.212120.60.1–2.3
  HPV18-related240000–0.712141.30.4–3.5
 HPV6/11/16 or 18-related cervical disease206000–0.71071b0.30–1.9
 HPV6/11/16 or 18-related genital warts or vulvar/vaginal disease256000–0.6126000–1.1
Males
 HPV6/11/16 or 18-related persistent infection or disease17320.40.1–1.59010.40–2.4
  HPV6-related17310.20–1.29010.40–2.4
  HPV11-related173000–0.890000–1.6
  HPV16-related17310.20–1.290000–1.6
  HPV18-related173000–0.890000–1.6
 HPV6/11/16 or 18-related persistent infection17120.40.1–1.68910.40–2.4
  HPV6-related17110.20–1.28910.40–2.4
  HPV11-related171000–0.889000–1.6
  HPV16-related17110.20–1.289000–1.6
  HPV18-related171000–0.889000–1.6
 HPV6/11/16 or 18-related disease173000–0.889000–1.6
  • CI, confidence interval; n, number of subjects with at least 1 follow-up visit for effectiveness. A subject is counted only once within each applicable row but may appear in more than 1 row.

  • a Number of subjects with an endpoint per 100 person-years-at-risk.

  • b The single case of cervical disease was HPV18-related CIN1.