Accepted for Publication: May 28, 2012.
Published Online: October 1, 2012. doi:10.1001/archpediatrics.2012.1451
Author Contributions: Dr Klein had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The Kaiser Study Team collected and analyzed all data. Study concept and design: Klein, Hansen, Chao, Lewis, Sy, Liaw, and Jacobsen. Acquisition of data: Klein, Hansen, Slezak, Lewis, Deosaransingh, Sy, Ackerson, Takhar, and Jacobsen. Analysis and interpretation of data: Klein, Hansen, Chao, Velicer, Emery, Lewis, Sy, Ackerson, Cheetham, Liaw, Takhar, and Jacobsen. Drafting of the manuscript: Klein and Velicer. Critical revision of the manuscript for important intellectual content: Hansen, Chao, Emery, Slezak, Lewis, Deosaransingh, Sy, Ackerson, Cheetham, Liaw, Takhar, and Jacobsen. Statistical analysis: Hansen, Chao, Emery, Slezak, and Lewis. Obtained funding: Klein, Velicer, Liaw, and Jacobsen. Administrative, technical, and material support: Hansen, Velicer, Deosaransingh, Sy, Ackerson, Takhar, and Jacobsen. Study supervision: Klein, Hansen, Ackerson, Takhar, and Jacobsen.
Financial Disclosure: This study was funded by Merck & Co. Dr Klein receives research support from Merck & Co, GlaxoSmithKline, Pfizer, Novartis, and sanofi-pasteur for unrelated studies. Dr Jacobsen and Mr Slezak received research funding from Merck & Co for another study related to HPV4. Mr Slezak served as an unpaid consultant to Merck & Co. Dr Chao received research funding from Merck & Co, Amgen, and Pfizer for unrelated studies. Drs Velicer and Liaw are employees of Merck & Co.
Role of the Sponsor: The study sponsor, Merck & Co, provided substantial input into the study design and analytic plan. In collaboration with the Kaiser Study Team, the sponsor reviewed data analyses and helped draft and revise the manuscript. The Kaiser Study Team investigators made final decisions regarding manuscript edits.
Additional Contributions: We thank the Safety Review Committee for their valuable input throughout this study: Robert Davis, MD, MPH, Center for Health Research, Southeast, Kaiser Permanente of Georgia; Neal Halsey, MD, Bloomberg School of Public Health, The Johns Hopkins University; Robert M. Jacobson, MD, Department of Pediatric and Adolescent Medicine, Mayo Clinic; Edward Lammer, MD, Children's Hospital Oakland Research Institute; and Ann Reed, MD, chair, Department of Pediatric and Adolescent Medicine, Mayo Clinic.