Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05781191 |
| Other study ID # |
5169 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 13, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
March 2024 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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
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;
1. Identify subgroups most at risk of refusing co-administration;
2. Identify the most appropriate interventions and/or incentives to overcome the main
determinants of refusal to co-administer;
3. Identify the most appropriate interventions and/or incentives to overcome the main
determinants of co-administration refusal.
