Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome

March 4, 2024 updated by: Laurenti Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Cost-consequence Analysis of Influenza Vaccination Among the Staff of a Large Teaching Hospital in Rome, Italy: A Pilot Study

Flu vaccination, as well as being effective to prevent seasonal influenza, decreases staff illness and absenteeism and reduces costs resulting from loss of productivity. Despite the effectiveness of flu vaccination, the seasonal coverage among healthcare workers is usually low. The aim of this retrospective observational study is to analyze the vaccination coverage rate among all employees (healthcare workers and administrative staff) of a large teaching hospital in Rome during the 2017-2018 influenza season, to perform a cost-consequence analysis of influenza vaccination (by evaluating the absenteeism due to illness in the epidemic period), and to assess the impact of vaccination in terms of both costs and sick days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5483

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario "A.Gemelli" IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population is represented by all employed healthcare workers of the FPG amounting to approximately 5000 (data provided by the Human Resources Department of the Hospital in December 2017).

The case group consists of all healthcare workers vaccinated in the 2017-2018 season at the specially designated facilities within the Teaching Hospital, filed on special registers.

The control group consists of healthcare workers who were not vaccinated in the 2017-2018 season at the specially designated facilities within the Teaching Hospital.

Description

Inclusion Criteria:

• Healthcare workers at Fondazione Policlinico Universitario "A.Gemelli" IRCCS

Exclusion Criteria:

• Healthcare workers not working at Fondazione Policlinico Universitario "A.Gemelli" IRCCS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccinated subjects
Healthcare workers that received quadrivalent split inactivated non-adjuvanted flu vaccine Fluarix Tetra in a single administration
Drug: Flu Vaccine
Administration of quadrivalent split inactivated non-adjuvanted flu vaccine Fluarix Tetra
Unvaccinated subjects
Healthcare workers that did not received flu vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of the quadrivalent vaccine
Time Frame: 33 weeks
Effectiveness of the quadrivalent vaccine in reducing the number of working days lost due to influenza syndrome
33 weeks
Economic impact of the quadrivalent vaccine
Time Frame: 33 weeks
Economic impact (for the company and society) of vaccination as part of a vaccination campaign on the healthcare workers of the teaching hospital.
33 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expected economic savings for each one percentage point increase in vaccination coverage
Time Frame: 33 weeks
Expected economic savings for each one percentage point increase in coverage on the health personnel of the teaching hospital
33 weeks
Non-economic incentives for healthcare personnel who decide to vaccinate
Time Frame: 33 weeks
Non-economic incentives for healthcare personnel who decide to vaccinate, in view of the financial savings for the company, linked to increased vaccination coverage
33 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2017

Primary Completion (Actual)

April 29, 2018

Study Completion (Actual)

November 14, 2019

Study Registration Dates

First Submitted

March 11, 2023

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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