Combination Vaccines

A diverse team of leading experts comprehensively review the complex biology of a wide variety of vaccine combinations, as well as the technical, clinical, and regulatory aspects of their development. Topics covered range from the use of immunological correlates of efficacy, rather than efficacy per se, for the evaluation and licensure of vaccine combinations, to preserving a stable immunogenic mixture in appropriate containers according to accepted regulatory standards. Discussed in detail are the trivalent influenza vaccine, the pneumococcal polysaccharide vaccine, the MMR vaccine, the DTP vaccine and its combinations, and the quadrivalent rotavirus vaccine, all of which serve as models for the development of future combinations. Combination Vaccines: Development, Clinical Research, and Approval illuminates all the scientific, clinical, regulatory, and health care issues involved in the research, development, and human use of combination vaccines.

Kenneth R. Brown, md, Merck Research Laboratories (retired), Philadelphia, PA H. Fred Clark, PhD, Associate Professor, Section of Infectious Diseases, University of Pennsylvania School of Medicine, Children's Hospital of Philadelphia, PA Michael D. Decker, md, Associate Professor, Department of Preventive Medicine and Medicine, Division of Infectious Diseases, Vanderbilt University, Nashville, TN Kathryn M. Edwards, md, Professor, Department of Pediatrics, Division of Infectious Diseases, Vanderbilt University, Nashville, TN Ronald W. Ellis, PhD, Vice-President, Vaccine Development; General Manager, BioChem Pharma, Inc., Northborough, MA Lydia A. Falk, PhD, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD Karen L. Goldenthal, md, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD Peter A. Gross, md, Vice-Chair and Professor of Medicine, New Jersey Medical School; Chair, Department of Medicine, Hackensack University Medical Center, Hackensack, NJ Maurice R. Hilleman, PhD, Merck Institute for Therapeutic Research, Merck Research Laboratories, West Point, PA Agnes Hoffenbach, md, PhD, Clinical Program Director, Pasteur Merieux Connaught, Marnes-la-Coquette, France Chia-Lung Hsieh, PhD, Wyeth-Lederle Vaccines and Pediatrics, Sanford, NC Bert E. Johansson, md, Department of Pediatrics, Babies' and Children's Hospital, Columbia-Presbyterian Medical Center, New York Dennis M. Katkocin, PhD, Wyeth-Lederle Vaccines and Pediatrics, Pearl River, NY Robert Kohberger,, PhD, Wyeth-Lederle Vaccines and Pediatrics, Pearl River, NY Loris D. McVittie, md, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD Karen Midthun, md, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD Paul A. Offit, md, Professor, Section of Infectious Diseases, University of Pennsylvania School of Medicine, Children's Hospital of Philadelphia, Philadelphia, PA Peter Paradiso, PhD, Vice-President, Scientific Affairs and Research Strategy, Wyeth-Lederle Vaccines and Pediatrics, West Henrietta, NY Stanley Plotkin, md, Pasteur Merieux Connaught, Doylestown, PA Francis M. Ricci, PhD, Department of Regulatory Affairs, Merck Research Laboratories, West Point, PA Emmanuel Vidor, md, PhD, Clinical Program Director, Pasteur Merieux Connaught, Marnes-la-Coquette, France John R. Vose, PhD, Executive Director, Scientific and Regulatory Affairs, Pasteur Merieux MSD, Lyon Cedex, France