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临床试验/NCT01931813
NCT01931813已完成不适用

Pharmacoepidemiological Methodology to Evaluate the Vaccination Risk in Young Infants

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
DATA EXTRACTION

研究概览

简要总结

This project is the pilot step necessary to develop a system of vaccination pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for this challenge and case series analysis, with the use of linked medicoadministrative data for hospitalisations the reimbursement of healthcare costs. This linkage of medicoadministrative data is new in France. The example of the risk of hospitalisation for febrile convulsions in infants less than two years old following vaccination against diphtheria, tetanus and pertussis is given as the reference association. This choice is justified by the numerous publications over many years on the existence of this association (Miller et al BMJ 1981, Farrington et al Lancet 1995). In addition, as case series analyses have been carried out to assess this risk, the results can be compared directly (Lancet 1995). The study to determine whether the analysis tools are suitable for the data will be tackled at the following levels:

  • Validity of the selection of cases from administrative records alone using coding based on the international classification of diseases ICD10
  • Validity of the risk assessment. This methodology feasibility project must make it possible to identify the different potential problems. This is a prerequisite necessary for the systematic implementation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • For reimbursement data: All of the data concerning delivery (purchase of the vaccine at a pharmacy, prescription) and vaccination (consultation following the date of purchase) for infants younger than 2 years old, in the years 2007 and
  • For PMSI data: All of the hospitalisations in 2007 and 2008 for febrile convulsions in infants less than 3 years old in hospitals of the following departments: Côte d'Or, Doubs and Bas-Rhin

排除标准

  • 未提供

结局指标

主要结局

DATA EXTRACTION

时间窗: At the selection of patients

Dates of delivery (purchase of the vaccine at the pharmacy), prescription, and date of vaccination (consultation) and when necessary, the age, doses, dates of adverse events, identification of the hospital

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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