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 (HOSPIVAC)

Centre Hospitalier le Mans

Status: Unknown

Conditions: Vaccination

Treatments: Biological: Remedial vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT03587610

CHM-2017-S6/06

Details and patient eligibility

About

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.

Enrollment: 402 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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402 participants in 2 patient groups

Intervention arm

Active Comparator group

Description:

* 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.

Treatment:

Biological: Remedial vaccination

Standard care

No Intervention group

Description:

* 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.