Analysis of the Determinants of Refusal and Adherence to Coadministration of Influenza Vaccination With the Booster Dose of Anti-SARS-CoV-2 Vaccine Conducted on Health Care Personnel of the Fondazione Policlinico Universitario A. Gemelli IRCCS.

Study Overview
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Brief Summary
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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 (6). In particular, a recent randomized placebo-controlled phase IV study (7), 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 (8). The U.S. Centers for Disease Control and Prevention (CDC) supports that COVID-19 vaccines can be co-administered with other vaccines, including SIV (9). 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. (10) 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. (11) 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.

Official Title
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Analysis of the Determinants of Refusal and Adherence to Coadministration of Influenza Vaccination With the Booster Dose of Anti-SARS-CoV-2 Vaccine Conducted on Health Care Personnel of the Fondazione Policlinico Universitario A. Gemelli IRCCS.

Conditions
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Co-administration of COVID-19 and Influenza Vaccines

Intervention / Treatment
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* Biological: COMIRNATY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Employees<br> | Biological: COMIRNATY<br>* Booster (3rd) dose of COMIRNATY Seasonal dose of influenza vaccination based on patient's individual risk factors<br>* Other names: FLUARIX TETRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 31-12-2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association with vaccine hesitancy | Association between refusal of coadministration and vaccine hesitancy, both general and specific for influenza and/or SARS-CoV-2; | 31-12-2021 | 
| Sub-groups at risk | Identify the subgroups most at risk of refusing co-administration; | 31-12-2021 | 
| Most appropriate interventions | Identify the most appropriate interventions and/or incentives to overcome the main determinants of refusal to co-administer; | 31-12-2021 |