Clinical Trial: METHORIVAC - Vaccinal Pharmacoepidemiologic

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pharmacoepidemiological Methodology to Evaluate the Vaccination Risk in Young Infants

Brief Summary:

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.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire Dijon

Current Primary Outcome: DATA EXTRACTION [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centre Hospitalier Universitaire Dijon

Dates:
Date Received: August 27, 2013
Date Started:
Date Completion:
Last Updated: August 27, 2013
Last Verified: August 2013