29. Clinical Development Strategy: Nuts and Bolts

  1. W. John W. Morrow PhD, DSc, FRCPath2,
  2. Nadeem A. Sheikh PhD3,
  3. Clint S. Schmidt PhD4 and
  4. D. Huw Davies PhD5
  1. Candida Fratazzi MD and
  2. Claudio Carini MD, PhD

Published Online: 20 JUN 2012

DOI: 10.1002/9781118345313.ch29

Vaccinology: Principles and Practice

Vaccinology: Principles and Practice

How to Cite

Fratazzi, C. and Carini, C. (2012) Clinical Development Strategy: Nuts and Bolts, in Vaccinology: Principles and Practice (eds W. J. W. Morrow, N. A. Sheikh, C. S. Schmidt and D. H. Davies), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781118345313.ch29

Editor Information

  1. 2

    Seattle, WA, USA

  2. 3

    Dendreon Corporation, Seattle, WA, USA

  3. 4

    NovaDigm Therapeutics, Inc., Grand Forks, ND, USA

  4. 5

    University of California at Irvine, Irvine, CA, USA

Author Information

  1. Boston Biotech Clinical Research, Cambridge, MA, USA

Publication History

  1. Published Online: 20 JUN 2012
  2. Published Print: 3 AUG 2012

ISBN Information

Print ISBN: 9781405185745

Online ISBN: 9781118345313

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Keywords:

  • rotavirus vaccine;
  • human papilloma virus vaccine;
  • vaccine biomarkers;
  • global vaccine protocols;
  • vaccine safety;
  • vaccine immunogenicity and efficacy;
  • vaccine and disease epidemics;
  • vaccine worldwide protection;
  • vaccine immunization biomarkers;
  • diagnostic biomarkers

Summary

While relatively few vaccines receive FDA approval each year, two vaccines for prevention of rotavirus (RV) infection and two vaccines for prevention of human papillomavirus (HPV) were approved for marketing in the US between 2006 and 2009. Approval of these four vaccines represents notable advances in the protection of health in children and young adults worldwide. Clinical trial safety, immunization, and efficacy data for the rotavirus vaccines (RotaTeq®, Rotarix®) and the HPV vaccines (Gardasil®, Cervarix®) are discussed in this chapter.