| Characteristic . | Vaccine group No. (%) (n = 3689) . | Control group No. (%) (n = 3683) . |
|---|---|---|
| General | ||
| Mean age (SD), y | 30.0 (7.40) | 29.9 (7.33) |
| Younger subgroup, age 18–26 y | 1861 (50.4) | 1862 (50.6) |
| Senior subgroup, age 27–45 y | 1828 (49.6) | 1821 (49.4) |
| Baseline HPV-associated findings | ||
| HPV-16 | ||
| Detectable virus DNA from day 0 to month 7 | 141 (3.8) | 138 (3.7) |
| Detectable neutralizing antibodies on day 0 | 467 (12.7) | 459 (12.5) |
| Susceptible to infection* | 2985 (80.9) | 3013 (81.8) |
| HPV-18 | ||
| Detectable virus DNA from day 0 to month 7 | 53 (1.4) | 60 (1.6) |
| Detectable neutralizing antibodies on day 0 | 186 (5.0) | 180 (4.9) |
| Susceptible to infection* | 3300 (89.5) | 3292 (89.4) |
| Cytological findings at day 0 | ||
| NILM | 3341 (90.6) | 3354 (91.1) |
| ASC-US | 195 (5.3) | 192 (5.2) |
| Negative on Hybrid Capture-2 test | 109 (3.0) | 109 (3.0) |
| Positive on Hybrid Capture-2 test | 86 (2.3) | 83 (2.3) |
| LSIL | 108 (2.9) | 96 (2.6) |
| HSIL | 31 (0.8) | 26 (0.7) |
| ASC-H | 4 (0.1) | 10 (0.3) |
| AIS | 1 (0.03) | 0 (0.0) |
| AGC | 7 (0.2) | 2 (0.05) |
| Histopathological findings at day 0† | ||
| CIN1 | 40 (1.1) | 44 (1.2) |
| VaIN1 | 3 (0.08) | 2 (0.05) |
| CIN2 | 29 (0.8) | 32 (0.9) |
| CIN3 | 9 (0.2) | 13 (0.4) |
| MIC | 0 (0.0) | 1 (0.03) |
| SCC | 1 (0.03) | 1 (0.03) |
| Characteristic . | Vaccine group No. (%) (n = 3689) . | Control group No. (%) (n = 3683) . |
|---|---|---|
| General | ||
| Mean age (SD), y | 30.0 (7.40) | 29.9 (7.33) |
| Younger subgroup, age 18–26 y | 1861 (50.4) | 1862 (50.6) |
| Senior subgroup, age 27–45 y | 1828 (49.6) | 1821 (49.4) |
| Baseline HPV-associated findings | ||
| HPV-16 | ||
| Detectable virus DNA from day 0 to month 7 | 141 (3.8) | 138 (3.7) |
| Detectable neutralizing antibodies on day 0 | 467 (12.7) | 459 (12.5) |
| Susceptible to infection* | 2985 (80.9) | 3013 (81.8) |
| HPV-18 | ||
| Detectable virus DNA from day 0 to month 7 | 53 (1.4) | 60 (1.6) |
| Detectable neutralizing antibodies on day 0 | 186 (5.0) | 180 (4.9) |
| Susceptible to infection* | 3300 (89.5) | 3292 (89.4) |
| Cytological findings at day 0 | ||
| NILM | 3341 (90.6) | 3354 (91.1) |
| ASC-US | 195 (5.3) | 192 (5.2) |
| Negative on Hybrid Capture-2 test | 109 (3.0) | 109 (3.0) |
| Positive on Hybrid Capture-2 test | 86 (2.3) | 83 (2.3) |
| LSIL | 108 (2.9) | 96 (2.6) |
| HSIL | 31 (0.8) | 26 (0.7) |
| ASC-H | 4 (0.1) | 10 (0.3) |
| AIS | 1 (0.03) | 0 (0.0) |
| AGC | 7 (0.2) | 2 (0.05) |
| Histopathological findings at day 0† | ||
| CIN1 | 40 (1.1) | 44 (1.2) |
| VaIN1 | 3 (0.08) | 2 (0.05) |
| CIN2 | 29 (0.8) | 32 (0.9) |
| CIN3 | 9 (0.2) | 13 (0.4) |
| MIC | 0 (0.0) | 1 (0.03) |
| SCC | 1 (0.03) | 1 (0.03) |
Susceptible to infection by a relevant type of human papillomavirus (HPV, ie, negative for type-specific neutralizing antibodies on day 0 and negative for the relevant type of HPV DNA from day 0 to month 7. Missing data on neutralizing antibodies or DNA were not deemed negative. AGC = atypical glandular cells; AIS = adenocarcinoma in situ; ASC-H = atypical squamous cells cannot exclude high-grade lesion; ASC-US = Atypical squamous cells of undetermined significance; CIN1 = cervical intraepithelial neoplasia grade 1; CIN2 = cervical intraepithelial neoplasia grade 2; CIN3 = cervical intraepithelial neoplasia grade 3; HSIL = high-grade squamous intraepithelial lesion; LSIL = low-grade squamous intraepithelial lesion; MIC = microinvasive carcinoma; NILM = negative for intraepithelial lesion or malignancy; SCC = squamous cell carcinoma; VaIN1 = vaginal intraepithelial neoplasia grade 1.
No cases of vaginal intraepithelial neoplasia grade 2 or higher (VaIN2+) or vulvar intraepithelial neoplasia (VIN) were diagnosed at entry.
| Characteristic . | Vaccine group No. (%) (n = 3689) . | Control group No. (%) (n = 3683) . |
|---|---|---|
| General | ||
| Mean age (SD), y | 30.0 (7.40) | 29.9 (7.33) |
| Younger subgroup, age 18–26 y | 1861 (50.4) | 1862 (50.6) |
| Senior subgroup, age 27–45 y | 1828 (49.6) | 1821 (49.4) |
| Baseline HPV-associated findings | ||
| HPV-16 | ||
| Detectable virus DNA from day 0 to month 7 | 141 (3.8) | 138 (3.7) |
| Detectable neutralizing antibodies on day 0 | 467 (12.7) | 459 (12.5) |
| Susceptible to infection* | 2985 (80.9) | 3013 (81.8) |
| HPV-18 | ||
| Detectable virus DNA from day 0 to month 7 | 53 (1.4) | 60 (1.6) |
| Detectable neutralizing antibodies on day 0 | 186 (5.0) | 180 (4.9) |
| Susceptible to infection* | 3300 (89.5) | 3292 (89.4) |
| Cytological findings at day 0 | ||
| NILM | 3341 (90.6) | 3354 (91.1) |
| ASC-US | 195 (5.3) | 192 (5.2) |
| Negative on Hybrid Capture-2 test | 109 (3.0) | 109 (3.0) |
| Positive on Hybrid Capture-2 test | 86 (2.3) | 83 (2.3) |
| LSIL | 108 (2.9) | 96 (2.6) |
| HSIL | 31 (0.8) | 26 (0.7) |
| ASC-H | 4 (0.1) | 10 (0.3) |
| AIS | 1 (0.03) | 0 (0.0) |
| AGC | 7 (0.2) | 2 (0.05) |
| Histopathological findings at day 0† | ||
| CIN1 | 40 (1.1) | 44 (1.2) |
| VaIN1 | 3 (0.08) | 2 (0.05) |
| CIN2 | 29 (0.8) | 32 (0.9) |
| CIN3 | 9 (0.2) | 13 (0.4) |
| MIC | 0 (0.0) | 1 (0.03) |
| SCC | 1 (0.03) | 1 (0.03) |
| Characteristic . | Vaccine group No. (%) (n = 3689) . | Control group No. (%) (n = 3683) . |
|---|---|---|
| General | ||
| Mean age (SD), y | 30.0 (7.40) | 29.9 (7.33) |
| Younger subgroup, age 18–26 y | 1861 (50.4) | 1862 (50.6) |
| Senior subgroup, age 27–45 y | 1828 (49.6) | 1821 (49.4) |
| Baseline HPV-associated findings | ||
| HPV-16 | ||
| Detectable virus DNA from day 0 to month 7 | 141 (3.8) | 138 (3.7) |
| Detectable neutralizing antibodies on day 0 | 467 (12.7) | 459 (12.5) |
| Susceptible to infection* | 2985 (80.9) | 3013 (81.8) |
| HPV-18 | ||
| Detectable virus DNA from day 0 to month 7 | 53 (1.4) | 60 (1.6) |
| Detectable neutralizing antibodies on day 0 | 186 (5.0) | 180 (4.9) |
| Susceptible to infection* | 3300 (89.5) | 3292 (89.4) |
| Cytological findings at day 0 | ||
| NILM | 3341 (90.6) | 3354 (91.1) |
| ASC-US | 195 (5.3) | 192 (5.2) |
| Negative on Hybrid Capture-2 test | 109 (3.0) | 109 (3.0) |
| Positive on Hybrid Capture-2 test | 86 (2.3) | 83 (2.3) |
| LSIL | 108 (2.9) | 96 (2.6) |
| HSIL | 31 (0.8) | 26 (0.7) |
| ASC-H | 4 (0.1) | 10 (0.3) |
| AIS | 1 (0.03) | 0 (0.0) |
| AGC | 7 (0.2) | 2 (0.05) |
| Histopathological findings at day 0† | ||
| CIN1 | 40 (1.1) | 44 (1.2) |
| VaIN1 | 3 (0.08) | 2 (0.05) |
| CIN2 | 29 (0.8) | 32 (0.9) |
| CIN3 | 9 (0.2) | 13 (0.4) |
| MIC | 0 (0.0) | 1 (0.03) |
| SCC | 1 (0.03) | 1 (0.03) |
Susceptible to infection by a relevant type of human papillomavirus (HPV, ie, negative for type-specific neutralizing antibodies on day 0 and negative for the relevant type of HPV DNA from day 0 to month 7. Missing data on neutralizing antibodies or DNA were not deemed negative. AGC = atypical glandular cells; AIS = adenocarcinoma in situ; ASC-H = atypical squamous cells cannot exclude high-grade lesion; ASC-US = Atypical squamous cells of undetermined significance; CIN1 = cervical intraepithelial neoplasia grade 1; CIN2 = cervical intraepithelial neoplasia grade 2; CIN3 = cervical intraepithelial neoplasia grade 3; HSIL = high-grade squamous intraepithelial lesion; LSIL = low-grade squamous intraepithelial lesion; MIC = microinvasive carcinoma; NILM = negative for intraepithelial lesion or malignancy; SCC = squamous cell carcinoma; VaIN1 = vaginal intraepithelial neoplasia grade 1.
No cases of vaginal intraepithelial neoplasia grade 2 or higher (VaIN2+) or vulvar intraepithelial neoplasia (VIN) were diagnosed at entry.
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