Journal article
Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study
SR Skinner, A Szarewski, B Romanowski, SM Garland, E Lazcano-Ponce, J Salmerón, MR Del Rosario-Raymundo, RHM Verheijen, SC Quek, DP Da Silva, H Kitchener, KL Fong, C Bouchard, DM Money, A Ilancheran, ME Cruickshank, MJ Levin, A Chatterjee, JT Stapleton, M Martens Show all
Lancet | Published : 2014
Abstract
Background Although adolescent girls are the main population for prophylactic human papillomavirus (HPV) vaccines, adult women who remain at risk of cervical cancer can also be vaccinated. We report data from the interim analysis of the ongoing VIVIANE study, the aim of which is to assess the efficacy, safety, and immunogenicity of the HPV 16/18 AS04-adjuvanted vaccine in adult women. Methods In this phase 3, multinational, double-blind, randomised controlled trial, we randomly assigned healthy women older than 25 years to the HPV 16/18 vaccine or control (1:1), via an internet-based system with an algorithm process that accounted for region, age stratum, baseline HPV DNA status, HPV 16/18 s..
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Funding Acknowledgements
GlaxoSmithKline Biologicals SA.