Evaluation of the Impact of the Anti COVID-19 Vaccination Campaign Addressed to the Employees of an Italian Hospital.

NCT05774418 | Completed FDA Drug

• 1 other identifier: 3973
• Study Type: observational
• Target: 6,649
• Locations: 1 country
• Sites: 1

Brief Summary

Health workers, especially those in patient-facing roles, had a significantly increased risk of COVID-19 infection, having serious outcomes, and risking spreading the virus to patients and staff. Vaccination campaign planning suggests allocating initial supplies of BNT162b2 vaccine to health workers given the importance of early protection to safeguard the continuity of care to patients. The aim of the study is to assess the effectiveness and safety of BNT162b2 vaccine among the health workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The retrospective cohort study will be conducted among health staff working at the FPG. Vaccination data will collect from hospital records. The primary end points will be vaccine effectiveness and safety.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Vaccine Effectiveness

  BNT162b2 COVID-19 Vaccine effectiveness is interpreted as the proportionate reduction in disease attack rate among the vaccinated group

  3 months

• Vaccinese safety

  Regarding the safety analysis of BNT162b2 COVID-19 Vaccine, the results of vaccine safety were descriptive in nature. Categorical data are presented as absolute and relative number of patients. For continuous data, mean and standard deviation (SD) or median with interquartile range (i.e., 1st quartile and 3rd quartile) was used, depending on its distribution

  3 months

Study Arms (2)

vaccinated

Healthcare workers (aged ≥18 years) working at hospital sites who could provide written informed consent and who will complete the immunization program with the administration of the second dose after approximately 21 days from the first dose at the FPG

Biological: BNT162b2 COVID-19 Vaccine

unvaccinated

unvaccinated health workers

Interventions

BNT162b2 COVID-19 Vaccine BIOLOGICAL

BNT162b2 is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 18 years. BNT162b2 contains tozinameran, a messenger RNA (mRNA) molecule with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19. BNT162b2 is given as two injections, usually into the muscle of the upper arm, 3 weeks apart.

vaccinated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Employees of Fondazione Policlinico Universitario Agostino Gemelli IRCCS

You may qualify if:

• Healthcare workers (aged ≥18 years) working at hospital sites who could provide written informed consent and who completed the immunization program with the administration of the second dose after approximately 21 days from the first dose at the FPG will be included

You may not qualify if:

• Participants were excluded from this analysis if they either will have a positive PCR test after 31 December 2020 and had clinical contraindications to the administration of the vaccine.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

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

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 17, 2023
• Study Start: December 28, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)