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

Wheeler, Cosette M.Skinner, S. RachelRowena Del Rosario-Raymundo, M.Garland, Suzanne M.Chatterjee, ArchanaLazcano-Ponce, EduardoSalmeron, JorgeMcNeil, ShellyStapleton, Jack T.Bouchard, CelineMartens, Mark G.Money, Deborah M.Quek, Swee ChongRomanowski, BarbaraVallejos, Carlos S.ter Harmsel, BramPrilepskaya, VeraFong, Kah LengKitchener, HenryMinkina, GalinaLim, Yong Kuei TimothyStoney, TanyaChakhtoura, NahidaCruickshank, Margaret E.Savicheva, Alevtinada Silva, Daniel PereiraFerguson, MurdoMolijn, Anco C.Quint, Wim G. V.Hardt, KarinDescamps, DominiqueSuryakiran, Pemmaraju V.Karkada, NaveenGeeraerts, BrechtDubin, GaryStruyf, FrankVIVIANE Study Group2016-12-292016-12-292016-10Wheeler, C M, Skinner, S R, Rowena Del Rosario-Raymundo, M, Garland, S M, Chatterjee, A, Lazcano-Ponce, E, Salmeron, J, McNeil, S, Stapleton, J T, Bouchard, C, Martens, M G, Money, D M, Quek, S C, Romanowski, B, Vallejos, C S, ter Harmsel, B, Prilepskaya, V, Fong, K L, Kitchener, H, Minkina, G, Lim, Y K T, Stoney, T, Chakhtoura, N, Cruickshank, M E, Savicheva, A, da Silva, D P, Ferguson, M, Molijn, A C, Quint, W G V, Hardt, K, Descamps, D, Suryakiran, P V, Karkada, N, Geeraerts, B, Dubin, G, Struyf, F & VIVIANE Study Group 2016, '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', Lancet Infectious Diseases, vol. 16, no. 10, pp. 1154-1168. https://doi.org/10.1016/S1473-3099(16)30120-71473-3099ORCID: /0000-0002-8893-8620/work/102132251http://hdl.handle.net/2164/7913Acknowledgments 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 Jérôme Leemans (Keyrus Biopharma, Lasne, Belgium), Stéphanie Delval (XPE Pharma and Science, Wavre, Belgium), and Matthieu Depuydt (Business Decision Life Sciences, Brussels, Belgium), on behalf of GSK Vaccines15213761engSDG 3 - Good Health and Well-beingOF-STUDY ANALYSISINTRAEPITHELIAL NEOPLASIAQUADRIVALENT VACCINESUSTAINED EFFICACYCONTROLLED-TRIALHPV VACCINATIONCERVICAL-CANCERPATRICIA TRIALBROAD-SPECTRUMYOUNG-WOMENR MedicineREfficacy, 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 studyJournal article10.1016/S1473-3099(16)30120-71610