Clinical Evaluation of Vaccines

Richard Rupp, Bridget Hawkins

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

This chapter examines how vaccines go through the clinical trials process on their way to gaining approval for use in humans. The regulatory agencies that play a role in overseeing the conduct of clinical trials of vaccines vary in different regions of the world, but the overall goal-to provide evidence that a new vaccine is safe and effective-is the same in every country. This chapter also focuses on good clinical practice (GCP) guidelines that standardize the way in which clinical trials are performed in Australia, Europe, Japan, and the United States.

Original languageEnglish (US)
Title of host publicationVaccinology: An Essential Guide
PublisherWiley Blackwell
Pages260-272
Number of pages13
ISBN (Electronic)9781118638033
ISBN (Print)9780470656167
DOIs
StatePublished - Dec 9 2014

Keywords

  • Clinical trials
  • Good clinical practice
  • Human vaccines
  • Vaccine safety and efficacy

ASJC Scopus subject areas

  • Medicine(all)

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  • Cite this

    Rupp, R., & Hawkins, B. (2014). Clinical Evaluation of Vaccines. In Vaccinology: An Essential Guide (pp. 260-272). Wiley Blackwell. https://doi.org/10.1002/9781118638033.ch15