VaccinationHOSPIVACNCT03587610
Evaluation of a Tdap-IPV (Tetanus, Diphteria, Pertussis and Inactivated Polio) Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older
A study testing Remedial vaccination in people with Vaccination, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vaccination
- What is being tested?
- Remedial vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2018to 15 Mar 2020
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 65 years or older
- Patients capable of understanding and giving informed consent to participate in the study
- Valid social security coverage
Who cannot join
- Patients under judicial safeguard measures
- Refusal to participate in the study
- Vaccination contra-indication
- Patient already included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Tdap-IPV Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older in the French County of Sarthe
In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively.
The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older.
Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.
- Conditions
- Vaccination
- Being tested
- Remedial vaccination
- Keywords
- vaccination coverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remedial vaccinationBiological
- if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date
- if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | * if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date
* if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination. Receives: Biological: Remedial vaccination |
| Standard care | No intervention | * if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date * if the patients vaccinations are not up to date: the patient will be informed that a remedial vaccination is necessary and that he should contact his primary care provider after hospital discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older
Difference in the increase in vaccination coverage between the two arms, measured as a percentage
Measured: two months
Secondary outcomes (4)
Immunisation rate among patients 65 years of age or older in the Sarthe department of France
Pre-intervention vaccination coverage rate in both arms, measured as a percentage
Measured: two months
Immunisation rate according to sex among patients 65 years or older
Sex of patients included in the study
Measured: two months
Immunisation rate according to primary care coverage among patients 65 years of age or older
Primary care coverage is defined as having a regular primary care physician registered as such with French social security.
Measured: two months
Immunisation rate according to socio professional category
Socio professional category defined according to the French national institute for statistics and economic studies (INSEE)
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start24 May 2018
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, prospective, cluster randomized trial.
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Blanchi, M.D., Principal investigator, Centre Hospitalier du Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587610
- Sponsor's protocol ID
- CHM-2017-S6/06
- Acronym
- HOSPIVAC
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2018
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Tdap-IPV Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older in the French County of Sarthe
- ClinicalTrials.gov ID
- NCT03587610
- Acronym / sponsor ID
- HOSPIVAC / CHM-2017-S6/06
- Conditions
- Vaccination
- Keywords
- vaccination coverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 16 Jul 2018 (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 France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively.
The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older.
Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, prospective, cluster randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Biological: Remedial vaccination* if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date * if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination. |
| Standard care | No intervention | –* if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date * if the patients vaccinations are not up to date: the patient will be informed that a remedial vaccination is necessary and that he should contact his primary care provider after hospital discharge. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients aged 65 years or older
- Patients capable of understanding and giving informed consent to participate in the study
- Valid social security coverage
Key exclusion criteria (4 listed)
- Patients under judicial safeguard measures
- Refusal to participate in the study
- Vaccination contra-indication
- Patient already included in the study
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 |
|---|---|---|
| Remedial vaccination* if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date * if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination. | Biological | Intervention arm |
Primary outcome
Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older
Time frame: two months
Difference in the increase in vaccination coverage between the two arms, measured as a percentage
4 secondary outcomes
Immunisation rate among patients 65 years of age or older in the Sarthe department of France
Time frame: two months
Immunisation rate according to sex among patients 65 years or older
Time frame: two months
Immunisation rate according to primary care coverage among patients 65 years of age or older
Time frame: two months
Immunisation rate according to socio professional category
Time frame: two months
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 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sophie Blanchi, M.D. principal investigator
Centre Hospitalier du Mans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remedial vaccination in people with Vaccination, run by Centre Hospitalier le Mans 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 3 inclusion and 4 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 1 Jul 2026. 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?
Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older (time frame: two 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 1 Jul 2026.