Financial Disclosure: Dr Nichol has received research funding from Aviron, Pasteur-Merieux Connaught, Lyon, France, and Merck [[amp]] Co, West Point, Pa; Dr Gorse has received research funding from Aviron and VaxGen Inc, Brisbane, Calif; Dr Belshe has received research funding from Aviron and Wyeth-Lederle Vaccines and Pediatrics, St Davids, Pa; Drs Belshe and Wittes are paid consultants for Aviron; Dr Jackson has received research grants and honoraria from Aviron, Pasteur-Merieux Connaught, and Merck [[amp]] Co; and Dr Glezen has received vaccine from Aviron for a study funded by the National Institutes of Health.
Funding/Support: This study was sponsored by Aviron as part of the Collaborative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md, and a licensing agreement with the University of Michigan, Ann Arbor. Aviron, Mountain View, Calif, sponsored the study and contracted with Parexel International to manage the conduct of the trial. Data analysis was planned and approved by the analysis committee, chaired by Dr Nichol, and was submitted to the US Food and Drug Administration before unblinding occurred. Dr Belshe monitored vaccine safety. The manuscript was prepared by the authors listed and reviewed by Aviron.
Site Investigators for the Live Attenuated Influenza Virus Vaccine in Healthy Adults Trial Group (in descending order of numbers of subjects enrolled): Brian Schwartz, MD, Innovative Medical Research Inc, Townsend, Md, and Catonsville, Md; Keith Reisinger, MD, Primary Physicians Research, Pittsburgh, Pa; William Lang, MD, ViRx Inc, San Francisco, Calif; Lisa A. Jackson, MD, MPH, Immunization Studies Program, Center for Health Studies, Group Health Cooperative and Department of Epidemiology, University of Washington, Seattle; Geoffrey J. Gorse, MD, VA Medical Center and Department of Medicine, St Louis University, St Louis, Mo; Stan L. Block, MD, Kentucky Pediatric and Adult Research Inc, Bardstown; Karl V Sitz, MD, University of Arkansas for Medical Sciences, Division of Pulmonary and Critical Care Medicine, Little Rock; Gilbert M. Schiff, MD, Gamble Program, Division of Infectious Diseases, Children's Hospital Medical Center, Cincinnati, Ohio; Kristin L. Nichol, MD, MPH, Medicine Service, VA Medical Center and University of Minnesota, Minneapolis; Mark Snell, MD, Golden Valley Memorial Hospital, Clinton, Mo; Jeffrey Adelglass, MD, Research Across America, Dallas, Tex; Harry Keyserling, MD, Department of Pediatrics, Emory University School of Medicine, Atlanta, Ga; and James McCarty, MD, Pharmaceutical Clinical Trials Division, Hill Top Research Inc, Fresno, Calif.
Acknowledgments: We thank the site clinical coordinators and Parexel International for their efforts on this study. We are also grateful to the following people from Aviron: Nick Bulley, clinical research associate; Annette Marcantonio, clinical research associate; Rebecca Redman, MD, medical monitor; and Jennifer A. L. Smith, PhD, statistician.