8. Influence of age (PATRICIA trial).
| Outcome | Age |
Event/N Vaccine |
Event/N Placebo |
Relative risk (95% CI) |
Vaccine efficacy % (95% CI) |
P value for linear effect of age |
| In women with hrHPV DNA negative status at baseline | ||||||
| CIN2+ associated with HPV16/18 | 15‐17 | 1/1997 | 53/2022 | 0.02 (0.00 to 0.14) | 98% (86 to 100%) | 0.995 |
| 18‐20 | 0/1096 | 27/1144 | 0.02 (0.00 to 0.32) | 98% (68 to 100%) | ||
| 21‐25 | 0/2363 | 17/2281 | 0.03 (0.00 to 0.47) | 97% (53 to 100%) | ||
| CIN2+ irrespective of HPV types | 15‐17 | 34/1997 | 101/2022 | 0.34 (0.23 to 0.50) | 66% (50 to 77%) | 0.355 |
| 18‐20 | 10/1096 | 38/1144 | 0.27 (0.14 to 0.55) | 73% (45 to 86%) | ||
| 21‐25 | 17/2363 | 33/2281 | 0.50 (0.28 to 0.89) | 50% (11 to 72%) | ||
| CIN3+ associated with HPV16/18 | 15‐17 | 0/1997 | 14/2022 | 0.04 (0.00 to 0.61) | 96% (39 to100%) | 1.000 |
| 18‐20 | 0/1096 | 8/1144 | 0.07 (0.00 to 1.13) | 93% (‐13 to 100%) | ||
| 21‐25 | 0/2363 | 5/2281 | 0.10 (0.00 to 1.74) | 90%(‐74 to 100%) | ||
| CIN3+ irrespective of HPV types | 15‐17 | 2/1997 | 24/2022 | 0.08 (0.02 to 0.36) | 92% (64 to 98%) | 0.488 |
| 18‐20 | 1/1096 | 11/1144 | 0.09 (0.01 to 0.73) | 91% (27 to 99%) | ||
| 21‐25 | 0/2363 | 9/2281 | 0.05 (0.00 to 0.92) | 95% (8 to 100%) | ||
| Persistent HPV16/18 infection (6M) | 15‐17 | 14/1989 | 303/2020 | 0.05 (0.03 to 0.08) | 95% (92 to 97%) | 0..042 |
| 18‐20 | 9/1090 | 110/1125 | 0.08 (0.04 to 0.17) | 92%(83 to 96%) | ||
| 21‐25 | 12/2338 | 108/2249 | 0.11 (0.06 to 0.19) | 89% (81 to 94%) | ||
| Regardless of women’s baseline HPV DNA status | ||||||
| CIN2+ associated with HPV16/18 | 15‐17 | 21/2882 | 100/2892 | 0.21 (0.13 to 0.24) | 79% (66 to 87%) | 0.000 |
| 18‐20 | 23/1871 | 66/1908 | 0.36 (0.22 to 0.57) | 64% (43 to 78%) | ||
| 21‐25 | 46/3929 | 62/3898 | 0.74 (0.50 to 1.08) | 26% (‐8 to 50%) | ||
| CIN2+ irrespective of HPV types | 15‐17 | 112/2882 | 200/2892 | 0.56 (0.45 to 0.70) | 44% (30 to 55%) | 0.006 |
| 18‐20 | 62/1871 | 105/1908 | 0.60 (0.44 to 0.82) | 40% (18 to 56%) | ||
| 21‐25 | 113/3929 | 123/3898 | 0.91 (0.09 to 1.17) | 9% (‐17 to 29%) | ||
| CIN3+ associated with HPV16/18 | 15‐17 | 7/2882 | 36/2892 | 0.20 (0.09 to 0.44) | 80% (56 to 91%) | 0.000 |
| 18‐20 | 13/1871 | 30/1908 | 0.44 (0.23 to 0.84) | 56% (16 to 77%) | ||
| 21‐25 | 31/3929 | 28/3898 | 1.10 (0.66 to 1.83) | ‐10% (‐83 to 34%) | ||
| CIN3+ irrespective of HPV types | 15‐17 | 21/2882 | 61/2892 | 0.35 (0.21 to 0.57) | 65% (43 to 79%) | 0.008 |
| 18‐20 | 22/1871 | 44/1908 | 0.51 (0.31 to 0.85) | 49% (15 to 69%) | ||
| 21‐25 | 43/3929 | 53/3898 | 0.80 (0.54 to 1.20) | 20% (‐20 to 46%) | ||
| Persistent HPV16/18 infection (6M) | 15‐17 | 167/2916 | 588/2920 | 0.28 (0.24 to 0.34) | 72% (66 to 76%) | 0.000 |
| 18‐20 | 143/1925 | 283/1961 | 0.51 (0.43 to 0.62) | 49% (38 to 57%) | ||
| 21‐25 | 194/4009 | 356/3979 | 0.54 (0.46 to 0.64) | 46% (36 to 54% ) | ||
Source: Lehtinen 2012.
CIN: cervical intraepithelial neoplasia, CIN2+: CIN of degree II or worse, CIN3+: CIN of degree 3 or worse, HPV: human papillomavirus types..