Covid19COVIDVacImpacNCT04657263
Impact of the COVID-19 Pandemic on Vaccination
An observational study of Covid19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health. Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged… Read more about this study
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population was composed of person at risk of infection cared for in participating centers
Who may be able to join
- Person at risk of infection according to french 2019 immunization schedule
- Patients aged above 18 years old
Who cannot join
- Patient < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the COVID-19 Pandemic on Vaccination in Patients at Risk of Infection
The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.
Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.
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Two vaccines are recommended for person at risk of infection according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious in patients with chronic diseases (diabetes, cardiac insufficiency..) compared to the general population.
The vaccination coverage rate of at-risk populations is dramatically below the vaccination coverage targets set by the Ministry of Health. Indeed, there are many barriers to vaccination, medical and para-medical barriers, but also individual barriers.
The current COVID-19 pandemic has identified people at risk of severe infection and death risk, particularly those with co-morbidities (diabetes, cardiovascular disease, etc.). Thus, this pandemic may have contributed to change in patients' perceptions regarding both the risk of infection and the potential interest and benefit of vaccination.
- Conditions
- Covid19
- Being tested
- Vaccine coverage assessment
- Keywords
- People over 18 years old, vaccines, immunization schedule, Infection
- Medical subject headings
- COVID-19, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine coverage assessmentOther
Vaccine coverage assessment
| Study group | Role | What they receive |
|---|---|---|
| Person at risk of infection according to French 2019 immunization | Person at risk of infection according to French 2019 immunization Receives: Other: Vaccine coverage assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of persons at risk of infection up to date with their mandatory and recommended vaccinations during COVID19 pandemic
number of persons at risk of infection up to date with their mandatory and recommended vaccinations during COVID19 pandemic
Measured: 1 day
Secondary outcomes (1)
Number of persons at risk of infection accepting COVID19 vaccination
Number of persons at risk of infection accepting COVID19 vaccination
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Nov 2020
- Primary completion1 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril BREUKER, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657263
- Sponsor's protocol ID
- RECHMPL20_0655
- Acronym
- COVIDVacImpac
- Status last verified
- Oct 2021
- First submitted
- 7 Dec 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the COVID-19 Pandemic on Vaccination in Patients at Risk of Infection
- ClinicalTrials.gov ID
- NCT04657263
- Acronym / sponsor ID
- COVIDVacImpac / RECHMPL20_0655
- Conditions
- Covid19
- Keywords
- People over 18 years old, vaccines, immunization schedule, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 8 Dec 2020 (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 vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.
Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.
Two vaccines are recommended for person at risk of infection according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious in patients with chronic diseases (diabetes, cardiac insufficiency..) compared to the general population.
The vaccination coverage rate of at-risk populations is dramatically below the vaccination coverage targets set by the Ministry of Health. Indeed, there are many barriers to vaccination, medical and para-medical barriers, but also individual barriers.
The current COVID-19 pandemic has identified people at risk of severe infection and death risk, particularly those with co-morbidities (diabetes, cardiovascular disease, etc.). Thus, this pandemic may have contributed to change in patients' perceptions regarding both the risk of infection and the potential interest and benefit of vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Person at risk of infection according to French 2019 immunization | – | Other: Vaccine coverage assessmentPerson at risk of infection according to French 2019 immunization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population was composed of person at risk of infection cared for in participating centers
Key inclusion criteria (2 listed)
- Person at risk of infection according to french 2019 immunization schedule
- Patients aged above 18 years old
Key exclusion criteria (1 listed)
- Patient < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine coverage assessmentVaccine coverage assessment | Other | Person at risk of infection according to French 2019 immunization |
Primary outcome
number of persons at risk of infection up to date with their mandatory and recommended vaccinations during COVID19 pandemic
Time frame: 1 day
number of persons at risk of infection up to date with their mandatory and recommended vaccinations during COVID19 pandemic
1 secondary outcome
Number of persons at risk of infection accepting COVID19 vaccination
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Cyril BREUKER principal investigator
University Hospital, Montpellier
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 Covid19, run by University Hospital, Montpellier 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 2 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: finished, as of the sponsor's last update on 25 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of persons at risk of infection up to date with their mandatory and recommended vaccinations during COVID19 pandemic (time frame: 1 day). 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 25 Oct 2021.