Influenza Vaccine in Children With Asthma (VAGA)

December 16, 2019 updated by: Central Hospital, Nancy, France

Evaluation of the Immunization Coverage Against Influenza in Children With Asthma Followed at the Hospital of Nancy

The occurence of influenza can be a factor of imbalance of asthma. Asthma patients are recommended for annual influenza vaccination . However there is insufficient vaccination coverage of asthmatic patients despite this recommendation. The aim of this study is to evaluate the rate of influenza vaccination coverage of children with asthma aged from 6 month to 17 years of age followed in pediatric pneumology consultation at the university hospital of Nancy.

Study Overview

Detailed Description

Using a questionnaire, the investigator will estimate the percentage of the asthmatic patients vaccinated against influenza. He will then compare the 2 groups of vaccinated and unvaccinated patients : comparison of patients characteristics, comparison of asthma characteristics (severity, asthma control...). He will also analyze the causes of vaccination or non-vaccination.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children with asthma

Description

Inclusion Criteria:

  • asthmatic patients followed in pediatric pneumology consultation at university hospital of Nancy aged from 6 months to 17 years

Exclusion Criteria:

  • asthmatic children who have been followed for less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Asthmatic children vaccinated
Asthmatic children unvaccinated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of asthmatic patients vaccinated against influenza
Time Frame: through study completion, an average of 6 months
Percentage of patients vaccinated against influenza will be evaluate among children with asthma followed in pediatric pneumology consultation.
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographic characteristics of patients
Time Frame: through study completion, an average of 6 months
Socio-demographic characteristics will be recorded from the questionnaire and compare between the 2 groups : vaccinated and unvaccinated patients.
through study completion, an average of 6 months
Age of patients (years)
Time Frame: through study completion, an average of 6 months
Age of patients will be recorded from the questionnaire and compared between the 2 groups : vaccinated and unvaccinated patients.
through study completion, an average of 6 months
Asthma severity (mild, moderate, severe asthma)
Time Frame: through study completion, an average of 6 months
Asthma severity (mild, moderate, severe asthma) is assessed from the level of treatment required to control symptoms according to Global Initiative for Asthma (GINA) 2018 recommendations. The investigator will compare asthma severity between the 2 groups : vaccinated and unvaccinated patients.
through study completion, an average of 6 months
Asthma symptom control (well controled, partly controlled, uncontrolled)
Time Frame: through study completion, an average of 6 months
Level of asthma symptoms control (well controled, partly controlled, uncontrolled) is assessed from symptoms control tool, according to GINA 2018 recommendations. The investigator will compare asthma symptom control between the 2 groups : vaccinated and unvaccinated patients.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aurore Blondé, Dr, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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