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OpenTrials
Completed

NCT Number: NCT03587610

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

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.

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Key information

Conditions

Vaccination

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Le Mans

Le Mans, 72 000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older

    Time frame: two months

    Difference in the increase in vaccination coverage between the two arms, measured as a percentage

Secondary outcomes

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

    Time frame: two months

    Pre-intervention vaccination coverage rate in both arms, measured as a percentage

  2. Immunisation rate according to sex among patients 65 years or older

    Time frame: two months

    Sex of patients included in the study

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

    Time frame: two months

    Primary care coverage is defined as having a regular primary care physician registered as such with French social security.

  4. Immunisation rate according to socio professional category

    Time frame: two months

    Socio professional category defined according to the French national institute for statistics and economic studies (INSEE)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Official study 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

Acronym: HOSPIVAC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2018
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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