Author Contributions: Dr Pichichero 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: Pichichero.
Acquisition of data: Pichichero, Rennels, Edwards,
Blatter, Marshall, Bologa, Wang, Mills.
Analysis and interpretation of data: Pichichero,
Rennels, Edwards, Blatter, Bologa, Wang, Mills.
Drafting of the manuscript: Pichichero, Blatter.
Critical revision of the manuscript for important
intellectual content: Pichichero, Rennels, Edwards, Marshall, Bologa,
Statistical analysis: Pichichero.
Obtained funding: Pichichero.
Administrative, technical, or material support:
Rennels, Edwards, Marshall, Bologa.
Study supervision: Edwards, Blatter, Marshall,
Bologa, Wang, Mills.
Financial Disclosures: Drs Pichichero and Edwards
have received grants from Aventis, GlaxoSmithKline, and MedImmune. Dr Blatter
is on the speakers’ bureau for Aventis. Dr Marshall has received research
contracts, honoraria, and consultancies from Aventis.
Funding/Support: Funding for the study was
provided by Aventis Pasteur, now Sanofi Pasteur. Funding went to the academic
institutions of the authors.
Role of the Sponsor: The authors who are employees
of Aventis Pasteur participated in the design, supervision, and conduct of
the study; performed interpretation of the data; and provided critical review
of the manuscript. The sponsor played a principal role in the design and conduct
of the study. A contract research organization, PPD Development, made site
visits to ensure accuracy and integrity of the data and managed the study.
Independent Statistical Analysis: Jason Roy,
PhD, and Shirley Eberly, MS, of the Department of Biostatistics at the University
of Rochester Medical Center, Rochester, NY, performed a confirmatory statistical
analysis. Shayami Thanabalasundrum and James Trammel of Red River Statistics
Inc, Shreveport, La, as well as Aleksandra Kolenc-Saban, MSc, and James Sloan
of Aventis Pasteur performed data analyses and management. Aventis Pasteur
contracted with Red River Statistics for independent statistical review of
the data. Red River Statistics was not employed by Aventis Pasteur, nor were
there any other arrangements with Aventis Pasteur other than the contracted
arrangement. Analysis of the data was performed by the independent statistics
company and guided by the Food and Drug Administration for data requested
in association with the Biologics License Application (BLA) (presentations
for the BLA occurred on March 15, 2005).
Study Investigators: The following physicians
enrolled participants into the trial and performed study evaluations: Brian
Allen, Onalaska, Wis; Wilson P. Andrews, Jr, Marietta, Ga; Gerald Bader, Vancouver,
Wash; Ladan Bakhtari, Plano, Tex; David Bernstein, Cincinnati, Ohio; Mark
M. Blatter, Pittsburgh, Pa; Kenneth Bromberg, Brooklyn, NY; Daniel Brune,
Peoria, Ill; Timothy Craig, Hershey, Pa; Robert Daum, Chicago, Ill; Cornelia
Dekker, Stanford, Calif; Arnold del Pilar, Jr, South Bend, Ind; Kathryn M.
Edwards, Nashville, Tenn; Bryan D. Evans, Huntsville, Ala; Stephen M. Fries,
Boulder, Colo; David P. Greenberg, Pittsburgh, Pa; Susan A. Keathley, Little
Rock, Ark; Donald J. Kennedy, St Louis, Mo; Erik Lamberth, Sellersville, Pa;
Thomas Latiolais, Bossier City, La; Joseph Leader, Woburn, Mass; Gary Marshall,
Louisville, Ky; Emma E. McCarty, Shreveport, La; Douglas K. Mitchell, Norfolk,
Va; Laurie Peterson, Chippewa Falls, Wis; Michael Pichichero, Rochester, NY;
Sharon E. Prohaska, Kansas City, Mo; Alfredo Quinonez, San Diego, Calif; Margaret
B. Rennels, Baltimore, Md; David Paul Robinson, Columbia, Mo; Kevin G. Rouse,
Jonesboro, Ark; Joseph Saponaro, Jupiter, Fla; Shelly David Senders, University
Heights, Ohio; Charles Sheaffer, Chapel Hill, NC; Marc R. Shepard, Washington,
DC; Peter E. Silas, Layton, Utah; Alex Spyropoulos, Albuquerque, NM; Bradley
Sullivan, Marshfield, Wis; Leonard B. Weiner, Syracuse, NY.
Acknowledgment: We thank William Bartlett,
PhD, and Linda Young, who performed serology analyses; Kathy Heard and Jennifer
Kasztejna, who performed and oversaw trial monitoring; Robert Daum, MD, David
Johnson, MD, and Michael D. Decker, MD, who provided scientific advice; and
Lisa DeTora, PhD, and David Johnson, MD, who are both full-time employees
of Sanofi Pasteur in Swiftwater, Pa, and who assisted in the editing of the
Published Online: June 2, 2005 (doi:10.1001/jama.293.24.3003).