Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial.
Jorma Paavonen, David Jenkins, F Xavier Bosch, Paulo Naud, Jorge Salmerón, Cosette M Wheeler, Song-Nan Chow, Dan L Apter, Henry C Kitchener, Xavier Castellsague, Newton S de Carvalho, S Rachel Skinner, Diane M Harper, James A Hedrick, Unnop Jaisamrarn, Genara Am Limson, Marc Dionne, Wim Quint, Bart Spiessens, Pascal Peeters Show all
Lancet | Elsevier BV | Published : 2007
BACKGROUND: The aim of this interim analysis of a large, international phase III study was to assess the efficacy of an AS04 adjuvanted L1 virus-like-particle prophylactic candidate vaccine against infection with human papillomavirus (HPV) types 16 and 18 in young women. METHODS: 18,644 women aged 15-25 years were randomly assigned to receive either HPV16/18 vaccine (n=9319) or hepatitis A vaccine (n=9325) at 0, 1, and 6 months. Of these women, 88 were excluded because of high-grade cytology and 31 for missing cytology results. Thus, 9258 women received the HPV16/18 vaccine and 9267 received the control vaccine in the total vaccinated cohort for efficacy, which included women who had prevale..View full abstract