Evaluation of the Impact of the Anti COVID-19 Vaccination Campaign Addressed to the Employees of an Italian Hospital.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05774418 |
Recruitment Status :
Completed
First Posted : March 17, 2023
Last Update Posted : March 17, 2023
|
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Information provided by (Responsible Party):
Laurenti Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Condition or disease | Intervention/treatment |
---|---|
COVID-19 | Biological: BNT162b2 COVID-19 Vaccine |
Show detailed description
Study Type : | Observational |
Actual Enrollment : | 6649 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Evaluation of the Effectiveness and Safety of the BNT162b2 COVID-19 Vaccine in the Vaccination Campaign Among the Health Workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Actual Study Start Date : | December 28, 2020 |
Actual Primary Completion Date : | March 31, 2021 |
Actual Study Completion Date : | March 31, 2021 |
Resource links provided by the National Library of Medicine
Group/Cohort | Intervention/treatment |
---|---|
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
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. |
unvaccinated
unvaccinated health workers
|
Primary Outcome Measures :
- Vaccine Effectiveness [ Time Frame: 3 months ]BNT162b2 COVID-19 Vaccine effectiveness is interpreted as the proportionate reduction in disease attack rate among the vaccinated group
- Vaccinese safety [ Time Frame: 3 months ]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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Study Population
Employees of Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05774418
Locations
Italy | |
Fondazione Policlinico Universitario "A. Gemelli" IRCCS | |
Roma, RM, Italy, 00168 |
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible Party: | Laurenti Patrizia, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
ClinicalTrials.gov Identifier: | NCT05774418 |
Other Study ID Numbers: |
3973 |
First Posted: | March 17, 2023 Key Record Dates |
Last Update Posted: | March 17, 2023 |
Last Verified: | March 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |