Analysis of the Determinants of Adherence to Coadministration of Flu Vaccination With the Booster of COVID-19 Vaccine

NCT05781191 | Completed FDA Drug

• 1 other identifier: 5169
• Study Type: observational
• Target: 8,231
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Influenza; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Association with vaccine hesitancy

  31-12-2021

• Sub-groups at risk

  31-12-2021

• Most appropriate interventions

  31-12-2021

Study Arms (1)

Employees

Biological: COMIRNATY

Interventions

COMIRNATY BIOLOGICAL

Booster (3rd) dose of COMIRNATY Seasonal dose of influenza vaccination based on patient's individual risk factors

Also known as: FLUAD TETRA, FLUCELVAX TETRA, FLUARIX TETRA

Employees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Influenza, Human; COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Patrizia Laurenti, MD

  Fondazione Policlinico Universitario A. Gemelli IRCCS - Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Complex Operative Unit of Hospital Hygiene, University Polyclinic Foundation "A. Gemelli" IRCCS, Rome

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: November 13, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)