NLM AIDSLINE
On sample sizes to estimate the protective efficacy of a vaccine.
O'Neill RT; Food and Drug Administration, Center for Drug Evaluation
June 30, 1989
Stat Med. 1988 Dec;7(12):1279-88. Unique Identifier : AIDSLINE
To estimate vaccine protective efficacy, defined as VE = 1 - ARV/ARU
where ARV is the disease attack rate in the vaccinated group and ARU is
the disease attack rate in the controls, investigators have used both
cohort and case-control designs. For each design, we present a method
for calculation of the sample size required to provide an approximate
confidence interval for VE of predetermined width and probability of
coverage. The required sample size is a function of the desired width of
the confidence interval, the probability of coverage, the assumed VE,
and, for cohort designs, the assumed disease attack rate in the
controls, and for case-control designs, the assumed vaccine exposure
prevalence for the controls.
Child, Preschool Cohort Studies Human *Research Design
Vaccines/*STANDARDS JOURNAL ARTICLE
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