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

Not Applicable

• Conditions: Vaccination
• Interventions: Biological: Remedial vaccination

• Registration Number: NCT03587610
• Lead Sponsor: Centre Hospitalier le Mans

Brief 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.

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

Not available

Study Timeline

• Study Start: 2018-05-24
• Study First Submitted: 2018-06-21
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-16
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30
• Primary Completion: 2019-11
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 402

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	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.

Primary Outcome Measures

Name	Time	Method
Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older	two months	Difference in the increase in vaccination coverage between the two arms, measured as a percentage

Secondary Outcome Measures

Name	Time	Method
Immunisation rate according to sex among patients 65 years or older	two months	Sex of patients included in the study
Immunisation rate according to primary care coverage among patients 65 years of age or older	two months	Primary care coverage is defined as having a regular primary care physician registered as such with French social security.
Immunisation rate according to socio professional category	two months	Socio professional category defined according to the French national institute for statistics and economic studies (INSEE)
Immunisation rate among patients 65 years of age or older in the Sarthe department of France	two months	Pre-intervention vaccination coverage rate in both arms, measured as a percentage

Trial Locations

Locations (1)

Centre Hospitalier Le Mans; 🇫🇷 Le Mans, France