Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials

A pooled analysis of the safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine Cervarix™ (GlaxoSmithKline) was performed in a cohort of almost 30000 girls and women aged ≥10 years, 16142 who received at least one dose of the HPV-16/18 vaccine and 13811 who received one of three controls [Al(OH)3 or hepatitis A vaccine (720 or 360 EU)]. Data are available for a total of 45988 vaccine doses. Solicited local and general symptoms were recorded for 7 days after each dose. Serious adverse events (SAEs), pregnancies, medically significant conditions (MSCs) and new onset of chronic diseases (NOCDs), including new onset of autoimmune diseases (NOADs), were proactively monitored. Data were analyzed by vaccine group according to age (10–14, 15–25 and >25 years) and reporting period (Months 0–7, Months 7–12 and >Month 12). Rates of solicited local and general symptoms were higher in the HPV-16/18 vaccine group than in the control groups. However, compliance with the 3-dose schedule wa...