Journal article

Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: Randomised controlled trial

J Dillner, SK Kjaer, CM Wheeler, K Sigurdsson, OE Iversen, M Hernandez-Avila, G Perez, DR Brown, LA Koutsky, EH Tay, P García, KA Ault, SM Garland, S Leodolter, SE Olsson, GWK Tang, DG Ferris, J Paavonen, M Lehtinen, M Steben Show all

BMJ Online | B M J PUBLISHING GROUP | Published : 2010

Open access

Abstract

Objectives: To evaluate the prophylactic efficacy of the human papillomavirus (HPV) quadrivalent vaccine in preventing low grade cervical, vulvar, and vaginal intraepithelial neoplasias and anogenital warts (condyloma acuminata). Design: Data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). The trials were to be 4 years in length, and the results reported are from final study data of 42 months' follow-up. Setting: Primary care centres and university or hospital associated health centres in 24 countries and territories around the world. Participants: 17 622 women aged 16-26 ..

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University of Melbourne Researchers

Grants

Funding Acknowledgements

Merck Research Laboratories, a division of Merck & Company, funded these studies. Role of the funding source: The studies were designed by the sponsor (Merck & Company) in collaboration with external investigators and an external data and safety monitoring board. The sponsor collated the data, monitored the conduct of the study, performed the statistical analysis, and coordinated the writing of the manuscript with all authors. The authors were actively involved in the collection, analysis, or interpretation of the data, the revising of the manuscript for intellectual content, and approved the final manuscript. JD has received consultancy fees, lecture fees, and research grants from Merck & Company and Sanofi Pasteur MSD. SKK has received consultancy fees and has received funding through her institution to conduct HPV vaccine studies for Sanofi Pasteur MSD and Digene. SMG has received advisory board fees and grant support from Commonwealth Serum Laboratories and GlaxoSmithKline, lecture fees from Merck & Company, and funding through her institution to conduct HPV vaccine studies for GlaxoSmithKline. CMW has received funding through her institution to conduct HPV vaccine studies for GlaxoSmithKline, and has received reagents and equipment from Roche Molecular Systems for HPV genotyping studies. KS has received consultancy fees from Merck & Company. O-EI has received lecture fees from Merck & Company and GlaxoSmithKline. LLV has received lecture fees, advisory board fees, and consultancy fees from Merck & Company and Sanofi Pasteur MSD. KAA has received consultancy and advisory board fees. MH-A has received lecture fees and grant support from Merck & Company. GP has received lecture fees and consultancy fees from Merck & Company and Sanofi Pasteur MSD. DRB has received lecture fees, advisory board fees, and intellectual property fees. SLe has received lecture fees from Merck & Company and Sanofi Pasteur MSD. S-EO has received lecture fees from Merck & Company. DGF has received consultancy fees and funding through his institution to conduct HPV vaccine studies for GlaxoSmithKline, and lecture fees and consultancy fees from Merck & Company. JP has received consultancy fees, advisory board fees, and lecture fees from Merck & Company. MS has received lecture fees and grant support from Merck & Company. FXB has received lecture fees from Merck & Company and GlaxoSmithKline, and has received funding through his institution to conduct HPV vaccine studies for GlaxoSmithKline. EAJ has received lecture fees from Merck & Company, Sanofi Pasteur MSD, and GlaxoSmithKline. SM has received lecture fees, advisory board fees, and consultancy fees from Merck & Company and Sanofi Pasteur MSD. NM has received lecture fees, advisory board fees, and consultancy fees from Merck & Company and Sanofi Pasteur MSD. Additionally, S-EO, CMW, MH-A, LLV, O-EI, GWKT, FXB, JP, JD, EHT, SLe, EAJ, SKK, GP, DGF, KS, MS, LAK, and DRB have received funding through their institutions to conduct HPV vaccine studies for Merck & Company. FJT, CR, AT, JTB, RM, SV, TMH, RH, and EB are employees of Merck & Company and potentially own stock or stock options in the company.