Pneumococcal vaccine schedules (PVS) study: a cluster-randomised, non-inferiority trial of an alternative versus standard schedule for pneumococcal conjugate vaccination—statistical analysis plan

Trials

Update

Stefan Flasche¹  Brian Greenwood²  Jukka Jokinen³  Arto A. Palmu³  Cattram Nguyen⁴  Kim Mulholland⁵  Isaac Osei⁶  Grant A. Mackenzie⁷ 

[1] Faculty of Epidemiology & Public Health, London School of Hygiene & Tropical Medicine, London, UK;Faculty of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK;Finnish Institute for Health and Welfare, Helsinki, Finland;Infection & Immunity Theme, Murdoch Children’s Research Institute, Melbourne, Australia;Infection & Immunity Theme, Murdoch Children’s Research Institute, Melbourne, Australia;Department of Paediatrics, University of Melbourne, Melbourne, Australia;Faculty of Epidemiology & Public Health, London School of Hygiene & Tropical Medicine, London, UK;MRC Unit The Gambia at London School of Hygiene & Tropical Medicine, Fajara, The Gambia;Faculty of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK;MRC Unit The Gambia at London School of Hygiene & Tropical Medicine, Fajara, The Gambia;Faculty of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK;Infection & Immunity Theme, Murdoch Children’s Research Institute, Melbourne, Australia;Department of Paediatrics, University of Melbourne, Melbourne, Australia;

关键词: Pneumococcal;    Vaccine;    Schedule;    Cluster-randomised;    Statistical analysis plan;   

DOI  :  10.1186/s13063-022-06900-x

 received in 2022-05-11, accepted in 2022-11-08,  发布年份 2022

来源: Springer

【 摘 要 】

RationaleThe effectiveness of universal immunisation with pneumococcal conjugate vaccine (PCV) has been evident in many countries. However, the global impact of PCV is limited by its cost, which has prevented its introduction in several countries. Reducing the cost of PCV programmes may facilitate vaccine introduction in some countries and improve the sustainability of PCV in EPIs in low-income countries when they transition away from subsidised vaccine supply.Methods and designPVS is a real-world field trial of an alternative schedule of one dose of PCV scheduled at age 6 weeks with a booster dose at age 9 months (i.e. the alternative ‘1+1’ schedule) compared to the standard schedule of three primary doses scheduled at 6, 10, and 14 weeks of age (i.e. the standard ‘3+0’ schedule). Delivery of the interventions began in late 2019 in 68 geographic clusters and will continue for 4 years. The primary endpoint is the prevalence of nasopharyngeal vaccine-type pneumococcal carriage in children aged 2–260 weeks with clinical pneumonia in year 4. Secondary endpoints are the prevalence of vaccine-type pneumococcal carriage among all ages in year 4 and the incidence of radiological pneumonia in children enrolled to receive the interventions. Additional disease and carriage endpoints are included.PurposeThis statistical analysis plan (SAP) describes the cohorts and populations, and follow-up criteria, to be used in different analyses. The SAP defines the endpoints and describes how adherence to the interventions will be presented. We describe how analyses will account for the effect of clustering and stratified randomisation. The SAP defines the approach to non-inferiority and other analyses. Defining the SAP early in the trial will avoid bias in analyses that may arise from prior knowledge of trial findings.

【 授权许可】

CC BY   
© The Author(s) 2022

【 图 表 】

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