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

NCT03587610 | Unknown

• 1 other identifier: CHM-2017-S6/06
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination

Keywords

vaccination coverage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Immunisation rate among patients 65 years of age or older in the Sarthe department of France

  two months

• Immunisation rate according to sex among patients 65 years or older

  two months

• Immunisation rate according to primary care coverage among patients 65 years of age or older

  two months

• Immunisation rate according to socio professional category

  two months

Study Arms (2)

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.

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.

Interventions

Remedial vaccination 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.

Intervention arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients under judicial safeguard measures
• Refusal to participate in the study
• Vaccination contra-indication
• Patient already included in the study

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Le Mans

Le Mans, 72 000, France

RECRUITING

Study Officials

• Sophie Blanchi, M.D.

  Centre Hospitalier du Mans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christelle Jadeau, P.D.

CONTACT

0243434343; cjadeau@ch-lemans.fr

Jean-Christophe Callahan, M.D.

CONTACT

0243434343; jccallahan@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, prospective, cluster randomized trial.

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 16, 2018
• Study Start: May 24, 2018
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 30, 2019

Record last verified: 2018-07

Locations

FR (1)