- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06304038
Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome
Cost-consequence Analysis of Influenza Vaccination Among the Staff of a Large Teaching Hospital in Rome, Italy: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Rome, Italy, 00168
- Fondazione Policlinico Universitario "A.Gemelli" IRCCS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
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
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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