Comparison design and evaluation power in cohort and self-controlled case series designs for post-authorization vaccine safety studies.

ABSTRACT:

Background

Post-authorization safety studies (PASSs) of vaccines are important. PASSs enable the evaluation of association between vaccination and adverse events following immunization through common study designs. Clinical trials during vaccine development typically include a few thousand to 10,000 participants while a PASS might aim to detect a few adverse events per 100,000 vaccine recipients. While all available data may be utilized, prior consideration of power analyses are nonetheless crucial for interpretation in cases where statistically significant differences are not found.

Methods

This research primarily examined cohort study design and self-controlled case series (SCCS) design, estimating the power of a PASS under plausible conditions.

Results

Both the coh

SUBMITTER: Sato S 

PROVIDER: S-EPMC10812582 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature