Combination Vaccines: Development, Clinical Research, and Approval

ISBN-13: 9781475748024 / Angielski / Miękka / 2013 / 279 str.

Ronald W. Ellis

Opis

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.

Spis treści

Pediatric Combination Vaccines, Emmanuel Vidor, Agnes Hoffenbach, and Stanley Plotkin. Combination Vaccines in Adolescents and Adults, Peter A. Gross. Pharmaceutical Aspects of Combination Vaccines, Dennis M. Katkocin and Chia-Lung Hsieh. Pediatric Combination Vaccines: Clinical Issues, Peter R. Paradiso and Robert Kohberger. Immunological Correlates for Efficacy of Combination Vaccines, Ronald W. Ellis. Influenza Vaccines, Bert E. Johansson. Vaccines Against Streptococcus pneumoniae, Kenneth R. Brown and Francis M. Ricci. Rotavirus Vaccines, Paul A. Offit and H. Fred Clark. Combined Measles, Mumps, and Rubella Vaccines, Maurice R. Hilleman. Combination Vaccines: Regulatory Considerations for Developers, John R. Vose. Testing and Licensure of Combination Vaccines for the Prevention of Infectious Diseases, Lydia A. Falk, Karen Midthun, Loris D. McVittie, and Karen L. Goldenthal. Issues for Health Practitioners in the Use of Combination Vaccines, Kathryn M. Edwards and Michael D. Decker. Index.