TetanusVAT65NCT03266211
Antitetanus Vaccination for People Older Than 65 Years.
An observational study of Tetanus, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In the last ten years, more than one hundred generalized tetanus cases were declared in France. Most of them were affecting people older than 70 years with an important mortality (around 28%). It is know that the only way to protect ourselves from this disease is the vaccination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- Questionnaire Patients and Questionnaire General practitioner
- Type of treatment
- Vaccines
- How many people
- 261 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2017to 23 Dec 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population will be all patients older than 65 years who are consulting their general practitioner and accepting to participate to the study. And their general practitioner.
Who may be able to join
- Patients older than 65 years consulting their attending physician in and who agreed to participate in the study.
- The doctors included are general practitioners located in a liberal office in the "Auvergne Rhône Alpes" region for which the URPS ("Union régional des Professionnels de Santé") has an email address.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Service Urgence et Réanimation Pédiatrique Hôpital Femme Mère Enfant Groupement Hospitalier Est
Bron, 69677
About this study
Official title: Antitetanus Vaccination for People Older Than 65 Years in the Auvergne-Rhône-Alpes (France) Region Depending on the Demographic and Medical Practice of Their Medical Practitioner.
In the last ten years, more than one hundred generalized tetanus cases were declared in France. Most of them were affecting people older than 70 years with an important mortality (around 28%). It is know that the only way to protect ourselves from this disease is the vaccination. In France tetanus vaccination is mandatory since 1940.
Nowaday none study looked specifically for the vaccination of people older than 65 years. The hypothesis is: there is a difference in the tetanus vaccination coverage for people older than 65 years depending on the demographic and medical practice of their general practitioner.
- Conditions
- Tetanus
- Being tested
- Questionnaire Patients, Questionnaire General practitioner
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire PatientsOther
Patient will have to answer a quiz which is about their vaccination against tetanus.
Questionnaire General practitionerOther
General practitioner will have to answer a quiz which is about their medical practice concerning vaccination against tetanus.
| Study group | Role | What they receive |
|---|---|---|
| Patients | People older than 65 years in the Auvergne-Rhônes-Alpes region who are consulting their general practitioner. Receives: Other: Questionnaire Patients | |
| General practitioner | General practitioner of the Auvergne-Rhônes-Alpes region Receives: Other: Questionnaire General practitioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tetanus vaccination coverage
Patient will have to answer a quiz which is about their vaccination against tetanus.
Measured: About 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start9 Nov 2017
- Primary completion23 Dec 2017
- Study completion23 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266211
- Sponsor's protocol ID
- 69HCL17_0375
- Acronym
- VAT65
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 12 Jun 2018
- 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antitetanus Vaccination for People Older Than 65 Years in the Auvergne-Rhône-Alpes (France) Region Depending on the Demographic and Medical Practice of Their Medical Practitioner.
- ClinicalTrials.gov ID
- NCT03266211
- Acronym / sponsor ID
- VAT65 / 69HCL17_0375
- Conditions
- Tetanus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 23 Dec 2017 (actual)
- Study completion
- 23 Dec 2017 (actual)
- First posted
- 30 Aug 2017 (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.
In the last ten years, more than one hundred generalized tetanus cases were declared in France. Most of them were affecting people older than 70 years with an important mortality (around 28%). It is know that the only way to protect ourselves from this disease is the vaccination. In France tetanus vaccination is mandatory since 1940.
Nowaday none study looked specifically for the vaccination of people older than 65 years. The hypothesis is: there is a difference in the tetanus vaccination coverage for people older than 65 years depending on the demographic and medical practice of their general practitioner.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Questionnaire PatientsPeople older than 65 years in the Auvergne-Rhônes-Alpes region who are consulting their general practitioner. |
| General practitioner | – | Other: Questionnaire General practitionerGeneral practitioner of the Auvergne-Rhônes-Alpes region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be all patients older than 65 years who are consulting their general practitioner and accepting to participate to the study. And their general practitioner.
Key inclusion criteria (2 listed)
- Patients older than 65 years consulting their attending physician in and who agreed to participate in the study.
- The doctors included are general practitioners located in a liberal office in the "Auvergne Rhône Alpes" region for which the URPS ("Union régional des Professionnels de Santé") has an email address.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Questionnaire PatientsPatient will have to answer a quiz which is about their vaccination against tetanus. | Other | Patients |
| Questionnaire General practitionerGeneral practitioner will have to answer a quiz which is about their medical practice concerning vaccination against tetanus. | Other | General practitioner |
Primary outcome
Tetanus vaccination coverage
Time frame: About 5 minutes
Patient will have to answer a quiz which is about their vaccination against tetanus.
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 12 Jun 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tetanus, run by Hospices Civils de Lyon 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 12 Jun 2018. 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?
Tetanus vaccination coverage (time frame: About 5 minutes). 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 12 Jun 2018.