Bandim Health Project, Research Unit OPEN, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Danish Institute for Advanced Study, University of Southern Denmark, Odense, Denmark.
BMJ Open. 2023 Feb 10;13(2):e065984. doi: 10.1136/bmjopen-2022-065984.
The aim of the NONSEnse project is to investigate the non-specific effects of vaccines and immunisation programmes on the overall health of children by using information from the extensive nationwide registers on health and sociodemographic factors in Denmark, Finland, Norway and Sweden.
The cohort covers 9 072 420 children aged 0-17 years, born 1990-2017/2018 and living in Denmark, Finland, Norway or Sweden. All countries use a unique identification number for its permanent residents, which makes it possible to link individual-level information from different registers.
Data collection and harmonisation according to a common data model was completed in March 2022. As a prerequisite for comparing the effects of childhood vaccinations on the overall health of children across the Nordic countries, we have identified indicators measuring similar levels of infectious disease morbidity across these settings. So far, studies pertaining to non-specific effects of vaccines are limited to investigations that could be undertaken using aggregated data sets that were available before the NONSEnse cohort with individual-level information was completely set up.
We are currently performing several studies of the effects on non-targeted infectious disease morbidity across the countries following vaccination against measles, mumps, rubella, diphtheria, tetanus, pertussis, human papillomavirus, rotavirus and influenza. Multiple studies are planned within the next years using different study designs to facilitate triangulation of results and enhance causal inference.
No clinical trials will be conducted within the NONSEnse project.
NONSEnse 项目旨在通过利用丹麦、芬兰、挪威和瑞典广泛的全国健康和社会人口因素登记册中的信息,研究疫苗和免疫接种计划对儿童整体健康的非特异性影响。
该队列包括 9072420 名年龄在 0-17 岁之间的儿童,他们出生于 1990-2017/2018 年,居住在丹麦、芬兰、挪威或瑞典。所有国家都为其永久居民使用唯一的身份识别号码,这使得从不同登记册中链接个人层面的信息成为可能。
根据共同的数据模型进行的数据收集和协调已于 2022 年 3 月完成。作为比较疫苗对北欧国家儿童整体健康影响的前提条件,我们已经确定了衡量这些环境中类似传染病发病率的指标。到目前为止,关于疫苗非特异性影响的研究仅限于使用在 NONSEnse 队列完全建立之前可用的、具有个体层面信息的聚合数据集进行的调查。
我们目前正在根据麻疹、腮腺炎、风疹、白喉、破伤风、百日咳、人乳头瘤病毒、轮状病毒和流感疫苗接种后对未针对的传染病发病率的影响,在这些国家进行几项研究。未来几年计划进行多项研究,采用不同的研究设计,以促进结果的三角验证并增强因果推理。
NONSEnse 项目内不会进行临床试验。