Pooled analysis of large and long‐term safety data from the human papillomavirus‐16/18‐AS04‐adjuvanted vaccine clinical trial programme

Abstract

Analysis of safety data arising from 57 580 subjects and 96 704 HPV-16/18-vaccine doses shows that the incidences and distribution of AEs were similar among HPV-16/18-vaccine recipients and controls. No new safety signals were identified. The data confirm previous findings that HPV-16/18-vaccine has an acceptable benefit-risk profile in adolescent girls and adult women.