Journal article
Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women
J Paavonen, P Naud, J Salmerón, CM Wheeler, SN Chow, D Apter, H Kitchener, X Castellsague, JC Teixeira, SR Skinner, J Hedrick, U Jaisamrarn, G Limson, S Garland, A Szarewski, B Romanowski, FY Aoki, TF Schwarz, W Poppe, FX Bosch Show all
Lancet | ELSEVIER SCIENCE INC | Published : 2009
Abstract
Background: The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine was immunogenic, generally well tolerated, and effective against HPV-16 or HPV-18 infections, and associated precancerous lesions in an event-triggered interim analysis of the phase III randomised, double-blind, controlled PApilloma TRIal against Cancer In young Adults (PATRICIA). We now assess the vaccine efficacy in the final event-driven analysis. Methods: Women (15-25 years) were vaccinated at months 0, 1, and 6. Analyses were done in the according-to-protocol cohort for efficacy (ATP-E; vaccine, n=8093; control, n=8069), total vaccinated cohort (TVC, included all women receiving at least one vaccine dose, regardles..
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Funding Acknowledgements
This study (NCT00122681/580299/008) was funded by GlaxoSmithKline Biologicals. We thank study participants and their families. We wish to dedicate this report to Minnamaija Kekki, a subinvestigator for this study, who sadly passed away.