Pneumococcal vaccine schedules (PVS) study: a cluster-randomised, non-inferiority trial of an alternative versus standard schedule for pneumococcal conjugate vaccination-statistical analysis plan.
Pneumococcal vaccine schedules (PVS) study: a cluster-randomised, non-inferiority trial of an alternative versus standard schedule for pneumococcal conjugate vaccination-statistical analysis plan.
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DOI：
10.1186/s13063-022-06900-x
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发表时间：
2022-12-28
期刊：
影响因子：
2.5
通讯作者：
Nguyen, Cattram
中科院分区：
文献类型：
--
作者：
Mackenzie, Grant A. A.;Palmu, Arto A. A.;Jokinen, Jukka;Osei, Isaac;Flasche, Stefan;Greenwood, Brian;Mulholland, Kim;Nguyen, Cattram
肺炎球菌结合疫苗(PCV)的普遍免疫效果在许多国家都很明显。然而，PCV的全球影响受到其成本的限制，这阻碍了它在几个国家的推广。降低PCV方案的成本可能会促进在一些国家引入疫苗，并在低收入国家从补贴疫苗供应过渡到EPI时提高这些国家的PCV的可持续性。PVS是一项真实的现场试验，与计划在6周、10周和14周计划的三种主要剂量的标准计划(即标准的“3+0”计划)相比，计划在6周龄接种一剂PCV的替代方案与在9个月龄增加一剂的方案(即，替代的‘1+1’方案)进行了比较。干预措施于2019年底在68个地理集群开始实施，并将持续4年。主要终点是第4年患有临床肺炎的2-260周儿童中鼻咽疫苗型肺炎球菌携带率，次要终点是第4年所有年龄段中疫苗型肺炎球菌携带率和登记接受干预的儿童中放射性肺炎的发病率。还包括其他疾病和运输终结点。该统计分析计划(SAP)描述了将在不同分析中使用的队列和总体以及后续标准。SAP定义了端点，并描述了如何遵守干预措施。我们描述了分析将如何解释集群和分层随机的影响。SAP定义了非劣势分析和其他分析的方法。在试验早期定义SAP将避免分析中可能因事先知道试验结果而产生的偏见。网上版载有补充材料，可在10.1186/s13063-022-06900-x查阅。
The 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. PVS 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. This 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. The online version contains supplementary material available at 10.1186/s13063-022-06900-x.
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影响因子：
2.5
作者：
Mackenzie GA;Osei I;Salaudeen R;Hossain I;Young B;Secka O;D'Alessandro U;Palmu AA;Jokinen J;Hinds J;Flasche S;Mulholland K;Nguyen C;Greenwood B
通讯作者：
Greenwood B
影响因子：
168.9
作者：
Cutts, FT;Zaman, SMA;Adegbola, RA
通讯作者：
Adegbola, RA
影响因子：
56.3
作者：
Mackenzie, Grant A.;Hill, Philip C.;Corrah, Tumani
通讯作者：
Corrah, Tumani
影响因子：
105.7
作者：
Campbell, Marion K.;Piaggio, Gilda;Altman, Douglas G.
通讯作者：
Altman, Douglas G.
影响因子：
56.3
作者：
Mackenzie, Grant A.;Hill, Philip C.;Corrah, Tumani
通讯作者：
Corrah, Tumani