Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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;
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Employees |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMIRNATY | Biological | Booster (3rd) dose of COMIRNATY Seasonal dose of influenza vaccination based on patient's individual risk factors |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrizia Laurenti, MD | Fondazione Policlinico Universitario A. Gemelli IRCCS - Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli | Roma | RM | 00168 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |