An Overview of the Vaccine Products licensed by US FDA Since Year 2000
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*Jingyee Kou, FDA 

Keywords: vaccine product, clinical trial design, sample size

There are 17 vaccine products licensed since year 2000. In this presentation, an overview on the clinical trial designs and sample sizes for pivotal phase 3 trials will be presented. All information is obtained from the public domain, such as briefing documents for the Vaccine and Related Biological Products Advisory Committee, or articles from medical or scientific journals.