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

Vaccination Clinical Trial

— HOSPIVAC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03587610
• Other study ID #: CHM-2017-S6/06
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: January 2020

Study information

• Verified date: July 2018
• Source: Centre Hospitalier le Mans
• Contact: Christelle Jadeau, P.D.
• Phone: 0243434343
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 402
• Est. completion date: January 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vaccination

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Le Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	two months
Secondary	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	two months
Secondary	Immunisation rate according to sex among patients 65 years or older	Sex of patients included in the study	two months
Secondary	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.	two months
Secondary	Immunisation rate according to socio professional category	Socio professional category defined according to the French national institute for statistics and economic studies (INSEE)	two months