SARS-CoV-2 post-vaccine surveillance studies in Australian children and adults with cancer: SerOzNET Statistical Analysis Plan

COVID-19 disease is associated with higher morbidity and mortality in cancer patients. Our study aimed to characterize the optimal strategy to improve vaccine induced protection against COVID-19 in children and adolescents with cancer. Results from The SerOzNET study will contribute comprehensive data on serology, cellular immune correlates from functional T-cell assays, quality of life data, and associated toxicity in relation to COVID-19 vaccination in children and adults with cancer. In this plan, we describe the statistics that will be used to report results of the SerOzNET study. SerOzNET examines COVID-19 vaccine response in children and adolescents with cancer. We have no conflicts of interest to disclose. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement Funding support was received from Cancer Australia, Victorian Cancer Agency, The Leukaemia Foundation (Australia), and Monash Health. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Monash Health Human Research and Ethics Committee gave ethical approval for this work. Study Title: SARS-CoV-2 post-vaccine surveillance studies in Australian children and adults with cancer [SerOzNET] HREC Reference Number: HREC/76506/MonH-2021-268415(v2) Monash Health Local Reference: RES-21-0000-337A ERM Project ID: 76506 research@monashhealth.org [www.monashhealth.org/page/research][1] I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors. * AE : Adverse Event ATAGI : Australian Technical Advisory Group on Immunization AZ : Astra Zeneca CALD : Culturally And Linguistically Diverse CDE : Common Data Elements eCRF : Electronic Case Report Form HREC : Human Research Ethics Committee ICH-GCP : International Conference on Harmonization Good Clinical Practice IgG : Immunoglobulin G LBA : Ligand Binding Assay Nab : Neutralizing Antibody QoL : Quality of Life PedsQL : Pediatric Quality of Life Scale PRO-CTCAE : Patient Reported Outcomes Common Terminology Criteria for Adverse Events MOGA : Medical Oncology Group of Australia PEG : Polyethylene glycol SAP : Statistical Analysis Plan SARS : CoV-2 Severe Acute Respiratory Syndrome Coronavirus Disease SerOzNET : SARS-CoV-2 post-vaccine surveillance studies in Australian children and adults with cancer [1]: https://www.monashhealth.org/page/research