Author Contributions: Dr Treanor had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Treanor, Schiff, Hayden, Cox.
Acquisition of data: Treanor, Schiff, Hayden, Brady, Hay, Meyer.
Analysis and interpretation of data: Treanor, Hayden, Hay, Holden-Wiltse, Liang, Gilbert, Cox.
Drafting of the manuscript: Treanor, Meyer, Gilbert, Cox.
Critical revision of the manuscript for important intellectual content: Treanor, Schiff, Hayden, Brady, Hay, Meyer, Holden-Wiltse, Liang, Cox.
Statistical analysis: Holden-Wiltse, Liang, Gilbert.
Obtained funding: Treanor, Schiff, Cox.
Administrative, technical, or material support: Treanor, Schiff, Hayden, Hay, Meyer, Cox.
Study supervision: Treanor, Schiff, Hayden, Brady.
Financial Disclosures: Dr Treanor reports receiving funding for influenza vaccine–related research from Sanofi Pasteur, Merck, and GlaxoSmithKline. Dr Brady reports receiving research support from GlaxoSmithKline. No other authors reported financial disclosures.
Funding/Support: Financial support for this study was provided by Protein Sciences Corp, manufacturer of the vaccine. Protein Sciences Corp also funded Ockham Development Group, which performed the data analysis and acted as the contract research organization for the study. The study was designed jointly by the investigators and Protein Sciences Corp.
Role of the Sponsor: Protein Sciences Corp and Dr. Treanor designed the study together, with significant input from Dr Gilbert. The study design was also reviewed and modified based on comments from the US Food and Drug Administration. Data analysis was initially performed by Dr Gilbert at Ockham, which was funded by Protein Sciences Corp; a second, independent analysis was performed by Drs Holden-Wiltse and Liang, who received no compensation from Protein Sciences Corp. Laboratory assays were performed in Cincinnati by Mr Meyer. Protein Sciences Corp had the opportunity to review and comment on the manuscript prior to submission, but Dr Treanor had final responsibility for writing and submitting the manuscript, with input from the other authors, including Dr Cox.
Independent Statistical Analysis: Jeanne Holden-Wiltse, MS, and Hua Liang, PhD, had access to the complete data set and performed independent analysis of all end points reported in this article. Except for minor typographical errors and rounding errors, their analysis was in agreement with the analysis performed by Ockham Development Group; the current report presents results after all discrepancies were resolved. Compensation for their efforts was provided by the University of Rochester. No funds to support the independent analysis were provided by either Protein Sciences Corp or by Ockham Development Group.
Acknowledgment: We acknowledge the efforts of study nurses and clinical coordinators Carrie Nolan, RN, Diane O’Brien, RN, Pat Smith, RN, and Mary Lou Werthman, RN, University of Rochester; Susan Parker, RN, and Amy Hoeper, RN, University of Virginia; and Maureen Tracey, RN, and Nicole R. Sanderfer, RN, Cincinnati Children's Hospital. These individuals were compensated for their activities via research contracts between Protein Sciences Corp and their respective institutions. We also thank Henk-André Kroon, MD, and Tam LaFleur, MS, Protein Sciences Corp, who served as project managers and the sponsor's medical monitor (Dr Kroon); and Richard L. Ward, PhD, Cincinnati Children's Hospital, for laboratory supervision (funded by a contract between Protein Sciences and Cincinnati Children's Hospital).