Table 2. Effectiveness of qHPV vaccination in women 24–45 years of age against HPV 6/11/16/18-related CIN or condyloma (cumulative incidence in the EVG, day 1 to year 6).
| Early Vaccination Group (N = 1,910) | |||||
| n | Cases | PYR | Rate | 95% CI | |
| Per-protocol population (PPE) | |||||
| HPV 6/11/16/18-Related CIN or Condyloma | 1,617 | 1 | 6,705.6 | 0.0 | (0.0, 0.1) |
| By HPV Type | |||||
| HPV 6-Related CIN or Condyloma | 1,330 | 0 | 5,515.4 | 0.0 | (0.0, 0.1) |
| HPV 11-Related CIN or Condyloma | 1,330 | 0 | 5,515.4 | 0.0 | (0.0, 0.1) |
| HPV 16-Related CIN or Condyloma | 1,351 | 1 | 5,611.5 | 0.0 | (0.0, 0.1) |
| HPV 18-Related CIN or Condyloma | 1,524 | 0 | 6,314.1 | 0.0 | (0.0, 0.1) |
| By Endpoint Type (HPV 6/11/16/18-Related) | |||||
| CIN (any grade) | 1,599 | 1 | 6,349.8 | 0.0 | (0.0, 0.1) |
| CIN 1 | 1,599 | 0 | 6,352.4 | 0.0 | (0.0, 0.1) |
| CIN 2 or worse | 1,599 | 1 | 6,349.8 | 0.0 | (0.0, 0.1) |
| CIN 2 | 1,599 | 1 | 6,349.8 | 0.0 | (0.0, 0.1) |
| CIN 3 | 1,599 | 0 | 6,352.4 | 0.0 | (0.0, 0.1) |
| AIS | 1,599 | 0 | 6,352.4 | 0.0 | (0.0, 0.1) |
| Cervical Cancer | 1,599 | 0 | 6,352.4 | 0.0 | (0.0, 0.1) |
| Condyloma | 1,617 | 0 | 6,696.8 | 0.0 | (0.0, 0.1) |
| Naïve to the relevant type population (HNRT) | |||||
| HPV 6/11/16/18-Related CIN or Condyloma | 1,863 | 4 | 8,511.0 | 0.0 | (0.0, 0.1) |
| By HPV Type | |||||
| HPV 6-Related CIN or Condyloma | 1,535 | 1 | 7,041.1 | 0.0 | (0.0, 0.1) |
| HPV 11-Related CIN or Condyloma | 1,535 | 0 | 7,041.6 | 0.0 | (0.0, 0.1) |
| HPV 16-Related CIN or Condyloma | 1,572 | 3 | 7,187.2 | 0.0 | (0.0, 0.1) |
| HPV 18-Related CIN or Condyloma | 1,760 | 0 | 8,052.8 | 0.0 | (0.0, 0.0) |
| By Endpoint Type (HPV 6/11/16/18-Related) | |||||
| CIN (any grade) | 1,862 | 3 | 8,108.1 | 0.0 | (0.0, 0.1) |
| CIN 1 | 1,862 | 1 | 8,110.7 | 0.0 | (0.0, 0.1) |
| CIN 2 or worse | 1,862 | 3 | 8,109.8 | 0.0 | (0.0, 0.1) |
| CIN 2 | 1,862 | 3 | 8,109.8 | 0.0 | (0.0, 0.1) |
| CIN 3 | 1,862 | 1 | 8,112.3 | 0.0 | (0.0, 0.1) |
| AIS | 1,862 | 0 | 8,112.4 | 0.0 | (0.0, 0.0) |
| Cervical Cancer | 1,862 | 0 | 8,112.4 | 0.0 | (0.0, 0.0) |
| Condyloma | 1,863 | 1 | 8,509.0 | 0.0 | (0.0, 0.1) |
| Full analysis set population (FAS) | |||||
| HPV 6/11/16/18-Related CIN or Condyloma | 1,910 | 36 | 8,601.8 | 0.4 | (0.3, 0.6) |
| By HPV Type | |||||
| HPV 6-Related CIN or Condyloma | 1,910 | 10 | 8,702.7 | 0.1 | (0.1, 0.2) |
| HPV 11-Related CIN or Condyloma | 1,910 | 1 | 8,728.9 | 0.0 | (0.0, 0.1) |
| HPV 16-Related CIN or Condyloma | 1,910 | 25 | 8,639.0 | 0.3 | (0.2, 0.4) |
| HPV 18-Related CIN or Condyloma | 1,910 | 3 | 8,724.9 | 0.0 | (0.0, 0.1) |
| By Endpoint Type (HPV 6/11/16/18-Related) | |||||
| CIN (any grade) | 1,909 | 29 | 8,303.6 | 0.3 | (0.2, 0.5) |
| CIN 1 | 1,909 | 17 | 8,310.6 | 0.2 | (0.1, 0.3) |
| CIN 2 or worse | 1,909 | 21 | 8,311.9 | 0.3 | (0.2, 0.4) |
| CIN 2 | 1,909 | 11 | 8,313.7 | 0.1 | (0.1, 0.2) |
| CIN 3 | 1,909 | 16 | 8,317.1 | 0.2 | (0.1, 0.3) |
| AIS | 1,909 | 0 | 8,319.2 | 0.0 | (0.0, 0.0) |
| Cervical Cancer | 1,909 | 0 | 8,319.2 | 0.0 | (0.0, 0.0) |
| Condyloma | 1,910 | 7 | 8,698.1 | 0.1 | (0.0, 0.2) |
N = Number of subjects in the indicated group who received at least 1 dose of the qHPV vaccine.
n = Number of subjects in the indicated analysis population.
PYR = person years at risk; Rate = rate per 100 person years at risk; AIS = Adenocarcinoma in situ; CI = Confidence interval; CIN = Cervical intraepithelial neoplasia; HPV = Human papillomavirus; qHPV = Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine.