Asthma in ChildrenVAGANCT04086628
Influenza Vaccine in Children With Asthma
An observational study of Asthma in Children and Influenza Vaccine, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Asthma in Children, Influenza Vaccine, Immunization Coverage
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2019to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: children with asthma
Who may be able to join
- asthmatic patients followed in pediatric pneumology consultation at university hospital of Nancy aged from 6 months to 17 years
Who cannot join
- asthmatic children who have been followed for less than 1 year
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, 54500
Aurore Blondé, 0383154603, a.blonde@chru-nancy.fr
Sofia DA MOTA, damota.sofia@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma in Children, Influenza Vaccine, Immunization Coverage
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic children vaccinated | Not described | |
| Asthmatic children unvaccinated | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of asthmatic patients vaccinated against influenza
Percentage of patients vaccinated against influenza will be evaluate among children with asthma followed in pediatric pneumology consultation.
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Socio-demographic characteristics of patients
Socio-demographic characteristics will be recorded from the questionnaire and compare between the 2 groups : vaccinated and unvaccinated patients.
Measured: through study completion, an average of 6 months
Age of patients (years)
Age of patients will be recorded from the questionnaire and compared between the 2 groups : vaccinated and unvaccinated patients.
Measured: through study completion, an average of 6 months
Asthma severity (mild, moderate, severe asthma)
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.
Measured: through study completion, an average of 6 months
Asthma symptom control (well controled, partly controlled, uncontrolled)
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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start4 Nov 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurore Blondé, Dr, Principal investigator, CHRU nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086628
- Sponsor's protocol ID
- 2019-A01944-53
- Acronym
- VAGA
- Status last verified
- Dec 2019
- First submitted
- 22 Aug 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immunization Coverage Against Influenza in Children With Asthma Followed at the Hospital of Nancy
- ClinicalTrials.gov ID
- NCT04086628
- Acronym / sponsor ID
- VAGA / 2019-A01944-53
- Conditions
- Asthma in Children, Influenza Vaccine, Immunization Coverage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthmatic children vaccinated | – | – |
| Asthmatic children unvaccinated | – | – |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with asthma
Key inclusion criteria (1 listed)
- asthmatic patients followed in pediatric pneumology consultation at university hospital of Nancy aged from 6 months to 17 years
Key exclusion criteria (1 listed)
- asthmatic children who have been followed for less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Socio-demographic characteristics of patients
Time frame: through study completion, an average of 6 months
Age of patients (years)
Time frame: 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 symptom control (well controled, partly controlled, uncontrolled)
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurore Blondé, Dr principal investigator
CHRU nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Influenza Vaccine, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurore Blondé, Dr (0383154603, a.blonde@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of asthmatic patients vaccinated against influenza (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.