Immunogenicity and Safety of Human Papillomavirus-16/18 AS04-Adjuvanted Cervical Cancer Vaccine Coadministered With Combined Diphtheria-Tetanus-Acellular Pertussis–inactivated Poliovirus Vaccine to Girls and Young Women

Flow of participants through study. The month 1 ATP cohort was used for analysis of the dTpa-IPV immune response 1 month after the first vaccine dose. The month 7 or 8 ATP cohort was used for analysis of the HPV-16/HPV-18 immune response 1 month after the third vaccine dose. ATP = according-to-protocol; HPV group = HPV-16/18 AS04-adjuvanted vaccine at months 0, 1, and 6; HPV+dTpa-IPV group = dTpa-IPV at month 0 and HPV-16/18 AS04-adjuvanted vaccine at Months 0, 1, and 6; dTpa-IPV group = dTpa-IPV at month 0 and HPV-16/18 AS04-adjuvanted vaccine at Months 1, 2, and 7.

Immune response to HPV-16/18 AS04-adjuvanted vaccine 1 month after the third vaccine dose in initially seronegative girls and young women (month 7/8 ATP cohort for immunogenicity). Bars show geometric mean titer (GMT) and associated 95% confidence interval. Seroconversion (%) shown within the bars. Blue solid lines represent GMTs for peak antibody levels 1 month after the third vaccine dose for HPV-16 (9341.5 EU/mL [95% CI: 8760.4, 9961.1]) and HPV-18 (4769.6 EU/mL [95% CI: 4491.2, 5065.3]) in a phase 3 efficacy study [19]. Red dashed lines represent GMTs for natural infection antibody levels in women who had cleared HPV-16 infection (29.8 [95% CI: 28.5, 31.0] EU/mL) or HPV-18 infection (22.6 [95% CI: 21.6, 23.6] EU/mL) in a phase 3 efficacy study [19]. HPV group = HPV-16/18 AS04-adjuvanted vaccine at months 0, 1, and 6; HPV+dTpa-IPV group = dTpa-IPV at month 0 and HPV-16/18 AS04-adjuvanted vaccine at months 0, 1, and 6; dTpa-IPV group = dTpa-IPV at month 0 and HPV-16/18 AS04-adjuvanted vaccine at months 1, 2, and 7.