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Both individually and cluster randomized study designs have been used for vaccine trials to assess the effects of vaccine on reducing the risk of disease or infection. The choice between individually and cluster randomized designs is often driven by the target estimand of interest (eg, direct versus total), statistical power, and, importantly, logistic feasibility. To combat emerging infectious disease threats, especially when the number of events from one single trial may not be adequate to obtain vaccine effect estimates with a desired level of precision, it may be necessary to combine information across multiple trials. In this article, we propose a model formulation to estimate the direct, indirect, total, and overall vaccine effects combining data from trials with two types of study designs: individual‐randomization and cluster‐randomization, based on a Cox proportional hazards model, where the hazard of infection depends on both vaccine status of the individual as well as the vaccine status of the other individuals in the same cluster. We illustrate the use of the proposed model and assess the potential efficiency gain from combining data from multiple trials, compared to using data from each individual trial alone, through two simulation studies, one of which is designed based on a cholera vaccine trial previously carried out in Matlab, Bangladesh. [ABSTRACT FROM AUTHOR]

To estimate causal effects of vaccine on post-infection outcomes, Hudgens and Halloran (2006) defined a post-infection causal vaccine efficacy estimand VEI based on the principal stratification framework. They also derived closed forms for the maximum likelihood estimators of the causal estimand under some assumptions. Extending their research, we propose a Bayesian approach to estimating the causal vaccine effects on binary post-infection outcomes. The identifiability of the causal vaccine effect VEI is discussed under different assumptions on selection bias. The performance of the proposed Bayesian method is compared with the maximum likelihood method through simulation studies and two case studies - a clinical trial of a rotavirus vaccine candidate and a field study of pertussis vaccination. For both case studies, the Bayesian approach provided similar inference as the frequentist analysis. However, simulation studies with small sample sizes suggest that the Bayesian approach provides smaller bias and shorter confidence interval length. [ABSTRACT FROM AUTHOR]