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Standard Statistical Methods for the Analysis of Immunogenicity Data

In: Statistics in Clinical Vaccine Trials

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  • Jozef Nauta

    (Global Statistics, Solvay Pharmaceuticals)

Abstract

There is an ancient proverb, popularized by Spanish novelist Cervantes in his Don Quixote (1605), that says that the proof of the pudding is in the eating. Putting it figuratively, ideas and theories should be judged by testing them. For vaccines the test is the field efficacy trial. A group of disease-free subjects are randomized to be vaccinated with either the investigational vaccine or a placebo vaccine. The subjects are then followed-up, to see how many cases of the disease occur in the two arms of the trial. If in the investigational arm the number of cases is significantly lower than in the placebo group, this is considered to be proof that the investigational vaccine protects from infection.

Suggested Citation

  • Jozef Nauta, 2011. "Standard Statistical Methods for the Analysis of Immunogenicity Data," Springer Books, in: Statistics in Clinical Vaccine Trials, chapter 0, pages 19-46, Springer.
    • Handle: RePEc:spr:sprchp:978-3-642-14691-6_3
    DOI: 10.1007/978-3-642-14691-6_3
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