Author Contributions: Dr Snape and Ms Yu had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Snape, John,
Ceddia, Anemona, Halperin, Dobson, Pollard.
Acquisition of data: Snape, Perrett,
Ford, John, Pace, Langley, McNeil, Dull, Ceddia, Halperin, Dobson,
Analysis and interpretation of data:
Snape, Perrett, Pace, Yu, Langley, Dull, Ceddia, Anemona, Halperin,
Drafting of the manuscript: Snape.
Critical revision of the manuscript for important intellectual content: Snape, Perrett, John, Pace, Yu, Langley,
McNeil, Dull, Ceddia, Anemona, Halperin, Dobson, Pollard.
Statistical analysis: Yu, Dull, Anemona.
Obtained funding: Ceddia, Pollard.
Administrative, technical, or material support:
Perrett, John, Pace, Langley, Dull, Dobson, Pollard.
Study supervision: Snape, Langley,
Halperin, Dobson, Pollard.
Financial Disclosures: Dr Snape reports receiving financial assistance from Wyeth Vaccines and Novartis Vaccines to attend conferences and reports travel and accommodation expenses paid by Novartis Vaccines while working with Novartis Vaccines in Siena, Italy. Dr Perrett reports receiving financial assistance from Novartis to attend scientific meetings. Dr Pace reports receiving travel grants from GlaxoSmithKline and Wyeth to attend scientific meetings. Drs McNeil, Langley, and Halperin report receiving funding from all major vaccine manufacturers for performance of clinical trials.
Drs Dull, Ceddia, and Anemona are employees of Novartis Vaccines.
Dr Pollard acts as chief investigator for clinical trials conducted on behalf of Oxford University, sponsored by vaccine manufacturers (Novartis Vaccines, GlaxoSmithKline, Sanofi-Aventis, Sanofi-Pasteur MSD, and Wyeth Vaccines) and has received assistance from vaccine manufacturers to attend scientific meetings. Industry-sourced honoraria for lecturing or writing are paid directly to an independent charity or an educational/administrative fund held by the Department of Paediatrics,
University of Oxford. No other disclosures were reported.
Funding/Support: This study was funded by Novartis Vaccines and Diagnostics (formerly Chiron Vaccines). Dr Pollard is a Jenner Institute Investigator. Ms Yu is funded by the National Health Service
Role of the Sponsor: The sponsor (Novartis Vaccines and Diagnostics) was responsible for the development and manufacture of the study vaccine, for the development of the study protocol (with input from Drs Pollard, Halperin and Dobson), and for the initial data analysis.
Independent Statistical Analysis: Ly-Mee Yu, MSc, a medical statistician at the Centre for Statistics in Medicine,
affiliated with the University of Oxford, had access to all of the data used in the study and performed an independent analysis of the primary and key secondary end points reported in this article by repeating the calculations of group percentages, geometric mean titres, and their corresponding 95% CIs. The results of Ms Yu's analysis are reported in this article. She also verified the consistency between the objectives set out in the protocol, prespecified statistical analysis plan, and results of the statistical analysis produced by the sponsor. She found no discrepancy in these reports, and all results reported in this article were identical to those obtained by the sponsor. No direct compensation was paid by the sponsor for this reanalysis, except for the travel expenses and accommodation claims for the site visit. Employees of the sponsor reviewed the manuscript before submission for publication.
Additional Contributions: We are grateful to the staff at the Oxford Vaccine Group, The Vaccine Evaluation Center,
and the Canadian Center for Vaccinology for their support in collecting the samples and recruiting volunteers for the study and also to the participants and their families.