Table 2. End-of-study efficacy against the combined incidence of vaccine type-related infection of 6 months duration, CIN or EGL.
|
HPV 6/11/16/18-related outcomes
|
HPV 16/18-related outcomes
|
|||||||
|---|---|---|---|---|---|---|---|---|
|
n(m)
|
Observed |
n(m)
|
Observed | |||||
| Analysis population end point | qHPV | Placebo | efficacy | 95% CI | qHPV | Placebo | efficacy | 95% CI |
| Per-protocol efficacy population (PPE) | ||||||||
| Overall persistent infection, CIN, or EGL | 10 (4) | 86 (41) | 88.7 | (78.1, 94.8) | 8 (4) | 51 (23) | 84.7 | (67.5, 93.7) |
| 24–34-year-olds | 5 (2) | 56 (24) | 91.3 | (78.4, 97.3) | 5 (2) | 35 (13) | 86.0 | (64.0, 95.7) |
| 35–45-year-olds | 5 (2) | 30 (17) | 83.8 | (57.9, 95.1) | 3 (2) | 16 (10) | 81.8 | (36.3, 96.6) |
| By end point | ||||||||
| Persistent infection | 9 (2) | 85 (39) | 89.6 | (79.3, 95.4) | 7 (2) | 50 (21) | 86.2 | (69.4, 94.7) |
| CIN (any grade) | 1 (1) | 17 (9) | 94.1 | (62.5, 99.9) | 1 (1) | 13 (7) | 92.4 | (49.1, 99.8) |
| CIN 2/3 or worse | 1 (1) | 6 (4) | 83.3 | (−37.6, 99.6) | 1 (1) | 6 (4) | 83.4 | (−36.7, 99.6) |
| EGL | 0 (0) | 7 (4) | 100 | (30.8, 100) | 0 (0) | 0 (0) | NA | NA |
| Condyloma | 0 (0) | 7 (4) | 100 | (30.8, 100) | 0 (0) | 0 (0) | NA | NA |
| VIN 2/3 or VaIN 2/3 | 0 (0) | 0 (0) | NA | NA | 0 (0) | 0 (0) | NA | NA |
| HPV-naive to the relevant type population (NRT) | ||||||||
| Overall persistent infection, CIN, or EGL | 27 (20) | 130 (77) | 79.9 | (69.4, 87.3) | 19 (14) | 85 (48) | 78.3 | (64.0, 87.5) |
| 24–34-year-olds | 15 (11) | 90 (54) | 83.7 | (71.7, 91.3) | 13 (9) | 60 (33) | 78.7 | (60.7, 89.2) |
| 35–45-year-olds | 12 (9) | 40 (23) | 71.3 | (44.1, 86.3) | 6 (5) | 25 (15) | 78.0 | (42.6, 92.3) |
| By end point | ||||||||
| Persistent infection | 26 (19) | 129 (76) | 80.4 | (69.9, 87.7) | 18 (13) | 84 (47) | 79.1 | (64.9, 88.2) |
| CIN (any grade) | 3 (3) | 27 (16) | 89.0 | (64.1, 97.9) | 3 (3) | 21 (12) | 85.9 | (52.7, 97.3) |
| CIN 2/3 or worse | 3 (3) | 8 (4) | 62.7 | (−55.5, 93.6) | 3 (3) | 8 (4) | 62.9 | (−54.6, 93.7) |
| EGL | 2 (1) | 11 (8) | 81.9 | (17.2, 98.1) | 1 (1) | 0 (0) | NA | NA |
| Condyloma | 1 (0) | 11 (8) | 91.0 | (37.9, 99.8) | 0 (0) | 0 (0) | NA | NA |
| VIN 2/3 or VaIN 2/3 | 0 (0) | 0 (0) | NA | NA | 0 (0) | 0 (0) | NA | NA |
| Intention-to-treat population (ITT) | ||||||||
| Overall persistent infection, CIN, or EGL | 116 (108) | 214 (154) | 47.2 | (33.5, 58.2) | 95 (90) | 160 (115) | 41.6 | (24.3, 55.2) |
| 24–34-year-olds | 75 (71) | 134 (94) | 44.1 | (25.3, 58.5) | 60 (57) | 100 (70) | 39.4 | (16.0, 56.9) |
| 35–45-year-olds | 41 (37) | 80 (60) | 51.2 | (28.0, 67.3) | 35 (33) | 60 (45) | 43.9 | (13.4, 64.1) |
| By end point | ||||||||
| Persistent infection | 110 (102) | 211 (151) | 49.0 | (35.5, 59.9) | 91 (86) | 157 (112) | 42.8 | (25.5, 56.3) |
| CIN (any grade) | 29 (25) | 55 (41) | 47.5 | (16.3, 67.7) | 28 (24) | 48 (36) | 41.9 | (5.6, 64.9) |
| CIN 2/3 or worse | 21 (19) | 27 (21) | 22.4 | (−42.5, 58.3) | 21 (19) | 27 (21) | 22.4 | (−42.5, 58.3) |
| EGL | 11 (9) | 12 (9) | 8.5 | (−126.6, 63.4) | 3 (2) | 0 (0) | NA | NA |
| Condyloma | 7 (6) | 12 (9) | 41.8 | (−60.3, 80.6) | 0 (0) | 0 (0) | NA | NA |
| VIN 2/3 or VaIN 2/3 | 2 (1) | 0 (0) | NA | NA | 2 (1) | 0 (0) | NA | NA |
Abbreviations: CI=confidence interval; CIN=cervical intraepithelial neoplasia; EGL=external genital lesion; NA=not applicable; qHPV=quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; VaIN; =vaginal intraepithelial neoplasia; VIN=vulvar intraepithelial neoplasia.
n=number of cases at the end of study (mean follow-up time per subject of 3.8 years); m=number of cases in original report (mean follow-up time per subject of 2.2 years).
Subjects are counted once in each applicable end point category. A subject may appear in more than one category.