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

NCT ID: NCT03587610

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-24

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single center, prospective, cluster randomized trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention arm

* 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.

Group Type ACTIVE_COMPARATOR

Remedial vaccination

Intervention Type BIOLOGICAL

* 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

* 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients aged 65 years or older
* Patients capable of understanding and giving informed consent to participate in the study
* Valid social security coverage

Exclusion Criteria

* Patients under judicial safeguard measures
* Refusal to participate in the study
* Vaccination contra-indication
* Patient already included in the study
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier le Mans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie Blanchi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier du Mans

Locations

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Centre Hospitalier Le Mans

Le Mans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christelle Jadeau, P.D.

Role: CONTACT

0243434343

Jean-Christophe Callahan, M.D.

Role: CONTACT

0243434343

Facility Contacts

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Christelle Jadeau, PD

Role: primary

0 (33) 2 43 43 43 43 ext. 37 482

Jean-Christophe Callahan, MD

Role: backup

0 (33) 2 43 43 43 43 ext. 37 520

Other Identifiers

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CHM-2017-S6/06

Identifier Type: -

Identifier Source: org_study_id

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