- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04086628
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
Status
Unknown
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
- Name: Aurore Blondé, Dr
- Phone Number: 0383154603
- Email: a.blonde@chru-nancy.fr
Study Contact Backup
- Name: Sofia Da Mota
- Phone Number: 0634302496
- Email: s.damota@chru-nancy.fr
Study Locations
-
-
-
Vandoeuvre les Nancy, France, 54500
- Recruiting
- CHRU Nancy
-
Contact:
- Aurore Blondé
- Phone Number: 0383154603
- Email: a.blonde@chru-nancy.fr
-
Contact:
- Sofia DA MOTA
- Email: damota.sofia@gmail.com
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Orthomyxoviridae Infections
- Asthma
- Influenza, Human
Other Study ID Numbers
- 2019-A01944-53
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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