Influenza VaccineNCT06304038
Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome
An observational study of Influenza Vaccine and Cost-Benefit Analysis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine, Cost-Benefit Analysis
- What is being tested?
- Flu Vaccine
- Type of treatment
- Vaccines
- How many people
- 5,483 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2017to 14 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Healthcare workers at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
Who cannot join
- Healthcare workers not working at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Influenza Vaccine, Cost-Benefit Analysis
- Being tested
- Flu Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu VaccineDrug
Administration of quadrivalent split inactivated non-adjuvanted flu vaccine Fluarix Tetra
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated subjects | Healthcare workers that received quadrivalent split inactivated non-adjuvanted flu vaccine Fluarix Tetra in a single administration Receives: Drug: Flu Vaccine | |
| Unvaccinated subjects | Healthcare workers that did not received flu vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the quadrivalent vaccine
Effectiveness of the quadrivalent vaccine in reducing the number of working days lost due to influenza syndrome
Measured: 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.
Measured: 33 weeks
Secondary outcomes (2)
Expected economic savings for each one percentage point increase in vaccination coverage
Expected economic savings for each one percentage point increase in coverage on the health personnel of the teaching hospital
Measured: 33 weeks
Non-economic incentives for healthcare personnel who decide to vaccinate
Non-economic incentives for healthcare personnel who decide to vaccinate, in view of the financial savings for the company, linked to increased vaccination coverage
Measured: 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start16 Oct 2017
- Primary completion29 Apr 2018
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccineStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 5,483 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurenti Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304038
- Sponsor's protocol ID
- 2018
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-consequence Analysis of Influenza Vaccination Among the Staff of a Large Teaching Hospital in Rome, Italy: A Pilot Study
- ClinicalTrials.gov ID
- NCT06304038
- Acronym / sponsor ID
- 2018
- Conditions
- Influenza Vaccine, Cost-Benefit Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,483 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 29 Apr 2018 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated subjects | – | Drug: Flu VaccineHealthcare workers that received quadrivalent split inactivated non-adjuvanted flu vaccine Fluarix Tetra in a single administration |
| Unvaccinated subjects | – | –Healthcare workers that did not received flu vaccine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Healthcare workers at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
Key exclusion criteria (1 listed)
- Healthcare workers not working at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flu VaccineAdministration of quadrivalent split inactivated non-adjuvanted flu vaccine Fluarix Tetra | Drug | Vaccinated subjects |
Primary outcome
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
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.
2 secondary outcomes
Expected economic savings for each one percentage point increase in vaccination coverage
Time frame: 33 weeks
Non-economic incentives for healthcare personnel who decide to vaccinate
Time frame: 33 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Related trials for Influenza Vaccine
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Vaccine and Cost-Benefit Analysis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the quadrivalent vaccine (time frame: 33 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.