Infants Likely to Present Febrile Convulsions Clinical Trial
— METHORIVACOfficial title:
Pharmacoepidemiological Methodology to Evaluate the Vaccination Risk in Young Infants
| NCT number | NCT01931813 |
| Other study ID # | Quantin PHRC IR 2009 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | August 27, 2013 |
| Last updated | August 27, 2013 |
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.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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 2008. - 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 Exclusion Criteria: |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Dijon | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | DATA EXTRACTION | 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 | At the selection of patients | No |