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Research Paper

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

Dominique Descamps, Karin Hardt, Bart Spiessens, Patricia Izurieta, Thomas Verstraeten, Thomas Breuer and Gary Dubin

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 was high and did not differ between groups (93.4% for HPV-16/18 vaccine group versus 92.5% for pooled controls). No clinically relevant differences were seen between the HPV-16/18 vaccine and pooled control groups in rates of SAEs (2.8% versus 3.1%), MSCs (19.4% versus 21.4%), NOCDs (1.7% in both groups) or NOADs (0.4% versus 0.3%). Similarly, no differences in pregnancy outcomes or rates of withdrawals due to AEs or SAEs were observed between groups. In conclusion, analysis of this large database shows the HPV-16/18 AS04-adjuvanted cervical cancer vaccine to have a favorable safety profile in women of all ages.

Authors

Dominique Descamps

GlaxoSmithKline Biologicals; Rixensart, Belgium

Karin Hardt

GlaxoSmithKline Biologicals; Rixensart, Belgium

Bart Spiessens

GlaxoSmithKline Biologicals; Rixensart, Belgium

Patricia Izurieta

GlaxoSmithKline Biologicals; Rixensart, Belgium

Thomas Verstraeten

GlaxoSmithKline Biologicals; Rixensart, Belgium

Thomas Breuer

GlaxoSmithKline Biologicals; Rixensart, Belgium

Gary Dubin

GlaxoSmithKline Biologicals; King of Prussia, Pennsylvania USA