InfluenzaCoVFluNCT05781191
Analysis of the Determinants of Adherence to Coadministration of Flu Vaccination With the Booster of COVID-19 Vaccine
An observational study of Influenza and COVID-19, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study investigates healthcare workers' attitudes towards co-administering COVID-19 and seasonal influenza vaccines, a method supported globally for its efficiency and potential to lessen healthcare burdens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- COMIRNATY
- Type of treatment
- Vaccines
- How many people
- 8,231 participants
- Where
- 1 siteItaly
- Study dates
- 13 Nov 2021to 31 Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will have an expected duration of 6 months from the date of Ethics Committee approval. The data analyzed will refer to the period: November 13, 2021-December 31, 2021.
Who may be able to join
- All healthcare workers and non-employees of FPG and all Physicians in Specialty Training attached to UCSC will be enrolled during the period when the possibility of coadministration of the two vaccines (Sars-CoV-2 and influenza) was available at the Foundation at the Covid-19 Vaccine Center set up at Presidio Columbus and/or at specially designated facilities, i.e., between November 13, 2021 and December 31, 2021.
Who cannot join
- All individuals who have received vaccinations, influenza and/or anti-SARS-CoV-2 with booster dose, outside the window in which coadministration was available at FPG will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Determinants of Refusal and Adherence to Coadministration of Influenza Vaccination With the Booster of COVID-19 Vaccine on Health Care Workers of the Fondazione Policlinico Universitario "A. Gemelli" IRCCS
This study investigates healthcare workers' attitudes towards co-administering COVID-19 and seasonal influenza vaccines, a method supported globally for its efficiency and potential to lessen healthcare burdens. It explores various factors affecting workers' willingness to accept or decline this approach, ranging from demographic to logistical aspects, and examines the link between vaccine hesitancy and co-administration acceptance, aiming to identify and address hesitancy towards both vaccines
Read the detailed description
Analysis of the determinants of refusal and adherence to the coadministration of influenza vaccination with the booster dose of anti-SARS-CoV-2 vaccine conducted on healthcare personnel of the University Polyclinic Foundation "A. Gemelli" IRCCS New evidence now suggests that co-administration of COVID-19 vaccines with inactivated vaccines is acceptable in terms of immunogenicity and reactogenicity. In particular, a recent randomized placebo-controlled phase IV study, established that both ChAdOx1 and BNT162b2 COVID-19 vaccines could be safely co-administered with seasonal influenza (SIV) vaccines adjuvanted with MF59 or derived from cell culture, without any clinically significant increase in adverse events or immunologic inference.
Although limited data are available, Interim Guidelines issued by WHO suggest that such co-administration is acceptable. The U.S. Centers for Disease Control and Prevention (CDC) supports that COVID-19 vaccines can be co-administered with other vaccines, including SIV. Similarly, in October 2021 (i.e., just before the start of the 2021/2022 flu vaccination campaign), the Italian Ministry of Health gave the go-ahead for co-administration of the vaccine.
Vaccination programs against COVID-19 and seasonal influenza are currently being implemented in parallel in many countries. The administration of both vaccines during the same session would have several advantages. At the individual level, it would reduce the number of necessary health visits and provide timely protection against both diseases; these individual benefits may encourage greater uptake of the two vaccines. Also from the perspective of health system organization and management, co-administration could facilitate the implementation of both vaccine programs and reduce the overall burden on health services.
The primary objective of the study is to measure the modifiable and non-modifiable, subjective and objective, demographic, economic, social, cultural, occupational, logistical and personal determinants of refusal or adherence to co-administration of seasonal influenza vaccination with the booster dose of anti-SARS-CoV vaccine-Evaluate the association between refusal of co-administration and vaccine hesitancy, both general and specific for influenza and/or SARS-cov-2;
- Identify subgroups most at risk of refusing co-administration;
- Identify the most appropriate interventions and/or incentives to overcome the main determinants of refusal to co-administer;
- Identify the most appropriate interventions and/or incentives to overcome the main determinants of co-administration refusal.
- Being tested
- COMIRNATY
- Medical subject headings
- Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMIRNATYBiological
Also called FLUAD TETRA, FLUCELVAX TETRA, FLUARIX TETRA
Booster (3rd) dose of COMIRNATY Seasonal dose of influenza vaccination based on patient's individual risk factors
| Study group | Role | What they receive |
|---|---|---|
| Employees | Not described Receives: Biological: COMIRNATY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determinants of refusal of co-administration
Modifiable and nonmodifiable subjective and objective demographic, economic, social, cultural, occupational, logistical, and personal determinants of refusal or adherence to coadministration of seasonal influenza vaccination with the booster dose of anti-SARS-CoV-2 vaccine
Measured: 31-12-2021
Secondary outcomes (3)
Association with vaccine hesitancy
Association between refusal of coadministration and vaccine hesitancy, both general and specific for influenza and/or SARS-CoV-2;
Measured: 31-12-2021
Sub-groups at risk
Identify the subgroups most at risk of refusing co-administration;
Measured: 31-12-2021
Most appropriate interventions
Identify the most appropriate interventions and/or incentives to overcome the main determinants of refusal to co-administer;
Measured: 31-12-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start13 Nov 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 8,231 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurenti Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Patrizia Laurenti, MD, Principal investigator, Fondazione Policlinico Universitario A. Gemelli IRCCS - Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781191
- Sponsor's protocol ID
- 5169
- Acronym
- CoVFlu
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Determinants of Refusal and Adherence to Coadministration of Influenza Vaccination With the Booster of COVID-19 Vaccine on Health Care Workers of the Fondazione Policlinico Universitario "A. Gemelli" IRCCS
- ClinicalTrials.gov ID
- NCT05781191
- Acronym / sponsor ID
- CoVFlu / 5169
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,231 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Mar 2023 (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.
This study investigates healthcare workers' attitudes towards co-administering COVID-19 and seasonal influenza vaccines, a method supported globally for its efficiency and potential to lessen healthcare burdens. It explores various factors affecting workers' willingness to accept or decline this approach, ranging from demographic to logistical aspects, and examines the link between vaccine hesitancy and co-administration acceptance, aiming to identify and address hesitancy towards both vaccines
Detailed description
Analysis of the determinants of refusal and adherence to the coadministration of influenza vaccination with the booster dose of anti-SARS-CoV-2 vaccine conducted on healthcare personnel of the University Polyclinic Foundation "A. Gemelli" IRCCS New evidence now suggests that co-administration of COVID-19 vaccines with inactivated vaccines is acceptable in terms of immunogenicity and reactogenicity. In particular, a recent randomized placebo-controlled phase IV study, established that both ChAdOx1 and BNT162b2 COVID-19 vaccines could be safely co-administered with seasonal influenza (SIV) vaccines adjuvanted with MF59 or derived from cell culture, without any clinically significant increase in adverse events or immunologic inference.
Although limited data are available, Interim Guidelines issued by WHO suggest that such co-administration is acceptable. The U.S. Centers for Disease Control and Prevention (CDC) supports that COVID-19 vaccines can be co-administered with other vaccines, including SIV. Similarly, in October 2021 (i.e., just before the start of the 2021/2022 flu vaccination campaign), the Italian Ministry of Health gave the go-ahead for co-administration of the vaccine.
Vaccination programs against COVID-19 and seasonal influenza are currently being implemented in parallel in many countries. The administration of both vaccines during the same session would have several advantages. At the individual level, it would reduce the number of necessary health visits and provide timely protection against both diseases; these individual benefits may encourage greater uptake of the two vaccines. Also from the perspective of health system organization and management, co-administration could facilitate the implementation of both vaccine programs and reduce the overall burden on health services.
The primary objective of the study is to measure the modifiable and non-modifiable, subjective and objective, demographic, economic, social, cultural, occupational, logistical and personal determinants of refusal or adherence to co-administration of seasonal influenza vaccination with the booster dose of anti-SARS-CoV vaccine-Evaluate the association between refusal of co-administration and vaccine hesitancy, both general and specific for influenza and/or SARS-cov-2;
- Identify subgroups most at risk of refusing co-administration;
- Identify the most appropriate interventions and/or incentives to overcome the main determinants of refusal to co-administer;
- Identify the most appropriate interventions and/or incentives to overcome the main determinants of co-administration refusal.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Employees | – | Biological: COMIRNATY |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will have an expected duration of 6 months from the date of Ethics Committee approval. The data analyzed will refer to the period: November 13, 2021-December 31, 2021.
Key inclusion criteria (1 listed)
- All healthcare workers and non-employees of FPG and all Physicians in Specialty Training attached to UCSC will be enrolled during the period when the possibility of coadministration of the two vaccines (Sars-CoV-2 and influenza) was available at the Foundation at the Covid-19 Vaccine Center set up at Presidio Columbus and/or at specially designated facilities, i.e., between November 13, 2021 and December 31, 2021.
Key exclusion criteria (1 listed)
- All individuals who have received vaccinations, influenza and/or anti-SARS-CoV-2 with booster dose, outside the window in which coadministration was available at FPG will be excluded.
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 |
|---|---|---|
| COMIRNATYAlso: FLUAD TETRA, FLUCELVAX TETRA, FLUARIX TETRABooster (3rd) dose of COMIRNATY Seasonal dose of influenza vaccination based on patient's individual risk factors | Biological | Employees |
Primary outcome
Determinants of refusal of co-administration
Time frame: 31-12-2021
Modifiable and nonmodifiable subjective and objective demographic, economic, social, cultural, occupational, logistical, and personal determinants of refusal or adherence to coadministration of seasonal influenza vaccination with the booster dose of anti-SARS-CoV-2 vaccine
3 secondary outcomes
Association with vaccine hesitancy
Time frame: 31-12-2021
Sub-groups at risk
Time frame: 31-12-2021
Most appropriate interventions
Time frame: 31-12-2021
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 18 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Patrizia Laurenti, MD principal investigator
Fondazione Policlinico Universitario A. Gemelli IRCCS - Rome
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 and COVID-19, 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 18 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?
Determinants of refusal of co-administration (time frame: 31-12-2021). 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 18 Mar 2024.