Journal article

Efficacy of Human Papillomavirus 16 and 18 (HPV-16/18) AS04-Adjuvanted Vaccine against Cervical Infection and Precancer in Young Women: Final Event-Driven Analysis of the Randomized, Double-Blind PATRICIA Trial

Dan Apter, Cosette M Wheeler, Jorma Paavonen, Xavier Castellsague, Suzanne M Garland, S Rachel Skinner, Paulo Naud, Jorge Salmeron, Song-Nan Chow, Henry C Kitchener, Julio C Teixeira, Unnop Jaisamram, Genara Limson, Anne Szarewski, Barbara Romanowski, Fred Y Aoki, Tino F Schwarz, Willy AJ Poppe, F Xavier Bosch, Adrian Mindel Show all

mSphere | AMER SOC MICROBIOLOGY | Published : 2015

Abstract

We report final event-driven analysis data on the immunogenicity and efficacy of the human papillomavirus 16 and 18 ((HPV-16/18) AS04-adjuvanted vaccine in young women aged 15 to 25 years from the PApilloma TRIal against Cancer In young Adults (PATRICIA). The total vaccinated cohort (TVC) included all randomized participants who received at least one vaccine dose (vaccine, n = 9,319; control, n = 9,325) at months 0, 1, and/or 6. The TVC-naive (vaccine, n = 5,822; control, n = 5,819) had no evidence of high-risk HPV infection at baseline, approximating adolescent girls targeted by most HPV vaccination programs. Mean follow-up was approximately 39 months after the first vaccine dose in each co..

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Grants

Funding Acknowledgements

The study was funded by GlaxoSmithKline Biologicals SA, which designed the trial in collaboration with investigators and coordinated gathering, analysis, and interpretation of data. The development of the manuscript was supported and coordinated by GlaxoSmithKline Biologicals SA.D.D., G.D., F.S., K.H., and T.Z. are employed by the GSK group of companies. D.D. owns stock in the GSK group of companies, F.S. and G.D. own stock shares and stock options in the GSK group of companies, and G.D. holds relevant patents. All investigators at study clinical sites were funded through their institutions to do the study protocol. B.R., C.M.W., D.A., F.Y.A., J.C.T., J.P., J.S., M.L., P.N., S.M.G., S.R.S., U.J., and X.C. have received funding to do other HPV vaccine studies for GlaxoSmithKline Biologicals SA; M.L., J.P., J.S., and S.M.G. have received research funding, via their institutions, from Merck Sharp & Dohme, and J.S. has also received research funding from Qiagen; C.M.W. has received through her institution funding for HPV vaccine trials from Merck Sharp & Dohme and reagents and equipment from Roche Molecular Systems; X.C. has received research funding, via his institution, from Merck Sharp & Dohme, Sanofi Pasteur MSD; T.F.S. has received personal fees from GlaxoSmithKline Biologicals SA; S.R.S. has also received funding through her institution from CSL Ltd.; S.M.G. has received consulting fees from GlaxoSmithKline Biologicals SA, CSL Ltd., and Merck Sharp & Dohme; B.R. has received honoraria via her professional corporation from GlaxoSmithKline Biologicals SA; X.C. has received honoraria from GlaxoSmithKline Biologicals SA and Merck Sharp & Dohme, Sanofi Pasteur MSD; S.M.G. has received payment from Merck Sharp & Dohme for board membership and has received payment from GlaxoSmithKline Biologicals SA, Merck Sharp & Dohme, and CSL Ltd. for lectures, including service on a speakers' bureau; F.X.B. has received payment from GlaxoSmithKline Biologicals SA for lectures, including service on a speakers' bureau, and S.M.G. and S.R.S. have received payment from GlaxoSmithKline Biologicals SA for the development of educational presentations; S.R.S. received honoraria from GlaxoSmithKline Biologicals SA via her institution for membership on advisory boards and for presentation at educational seminars; F.Y.A. has received payment from GlaxoSmithKline Biologicals SA and Merck Sharp & Dohme for the development of educational presentations; B.R., C.M.W., S.R.S., and U.J. have received travel reimbursements from GlaxoSmithKline Biologicals SA; C.M.W. and F.X.B. have received travel reimbursements from Merck Sharp & Dohme, Sanofi Pasteur MSD; and S.M.G. has received travel reimbursements from GlaxoSmithKline Biologicals SA, Merck Sharp & Dohme, and CSL Ltd. A.M., G.L., H.C.K., P.D.S., S.N.C., and W.A.J.P. declare that they have no conflicts of interest.