NCT06304038

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2023

Completed
1 year until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 11, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Effectiveness of the quadrivalent vaccine

    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

    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 Outcomes (2)

  • Expected economic savings for each one percentage point increase in vaccination coverage

    33 weeks

  • Non-economic incentives for healthcare personnel who decide to vaccinate

    33 weeks

Study Arms (2)

Vaccinated subjects

Healthcare workers that received quadrivalent split inactivated non-adjuvanted flu vaccine Fluarix Tetra in a single administration

Drug: Flu Vaccine

Unvaccinated subjects

Healthcare workers that did not received flu vaccine

Interventions

Administration of quadrivalent split inactivated non-adjuvanted flu vaccine Fluarix Tetra

Vaccinated subjects

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario "A.Gemelli" IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2023

First Posted

March 12, 2024

Study Start

October 16, 2017

Primary Completion

April 29, 2018

Study Completion

November 14, 2019

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations