Journal article
Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study
CM Wheeler, SR Skinner, MR Del Rosario-Raymundo, SM Garland, A Chatterjee, E Lazcano-Ponce, J Salmerón, S McNeil, JT Stapleton, C Bouchard, MG Martens, DM Money, SC Quek, B Romanowski, CS Vallejos, B ter Harmsel, V Prilepskaya, KL Fong, H Kitchener, G Minkina Show all
Lancet Infectious Diseases | ELSEVIER SCI LTD | Published : 2016
Abstract
Background Although the risk of human papillomavirus (HPV) infection is greatest in young women, women older than 25 years remain at risk. We present data from the VIVIANE study of the HPV 16/18 AS04-adjuvanted vaccine in adult women after 7 years of follow-up. Methods In this phase 3, double-blind, randomised controlled trial, healthy women older than 25 years were enrolled (age stratified: 26–35 years, 36–45 years, and ≥46 years). Up to 15% in each age stratum had a history of HPV infection or disease. Women were randomly assigned (1:1) to receive HPV 16/18 vaccine or aluminium hydroxide control, with an internet-based system. The primary endpoint was vaccine efficacy against 6-month persi..
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Awarded by National Cancer Institute
Funding Acknowledgements
The VIVIANE study was funded and coordinated by GlaxoSmithKline Biologicals SA, which also covered all costs associated with development and publication of this report. We thank all study participants and their families. We gratefully acknowledge the work of the central and local study coordinators, and staff members of the sites who participated in this study. Writing support services were provided by Mary Greenacre (An Sgriobhadair, Isle of Barra, UK), on behalf of GSK Vaccines; editing and publication coordination services were provided by Jerome Leemans (Keyrus Biopharma, Lasne, Belgium), Stephanie Delval (XPE Pharma and Science, Wavre, Belgium), and Matthieu Depuydt (Business Decision Life Sciences, Brussels, Belgium), on behalf of GSK Vaccines.