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Cluster-randomized trials are often conducted to assess vaccine effects.Defining estimands of interest before conducting a trial is integral to thealignment between a study's objectives and the data to be collected andanalyzed. This paper considers estimands and estimators for overall, indirect,and total vaccine effects in trials where clusters of individuals arerandomized to vaccine or control. The scenario is considered where individualsself-select whether to participate in the trial and the outcome of interest ismeasured on all individuals in each cluster. Unlike the overall, indirect, andtotal effects, the direct effect of vaccination is shown in general not to beestimable without further assumptions, such as no unmeasured confounding. Anillustrative example motivated by a cluster-randomized typhoid vaccine trial isprovided.

Estimands and Inference in Cluster-Randomized Vaccine Trials