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SARS-CoV-2 post-vaccine surveillance studies in Australian children and adults with cancer: SerOzNET Quality of Life, Toxicity and Vaccine Beliefs Substudy Statistical Analysis Plan

Donoghue, M. W.; Body, A. L.; Wakefield, C.; Ahern, E. S.; Segelov, E.

2023-03-03 oncology
10.1101/2023.02.28.23286595 medRxiv
Show abstract

COVID-19 disease is associated with higher morbidity and mortality in cancer patients. SerOzNET is a prospective cohort study of adults and children with cancer undergoing routine SARS-CoV-2 vaccination in Australia. Peripheral blood was collected and processed at multiple points (one pre-vaccination and five or more post-vaccination) to address the primary aim of the study to assess the serological and immunological responses to vaccination. A secondary aim of the study was to "document patient response to vaccination using qualitative measures, including patient-reported outcomes, vaccine hesitancy survey and post-hoc toxicity recording" (body, et al.,2022). This statistical analysis plan describes the analysis of the data collected to address this aim. We will refer to this as the SerOzNET QoL Substudy. We have no conflicts of interest to disclose.

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