Clinical trial
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
Name
3973
Description
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.
Trial arms
Trial start
2020-12-28
Estimated PCD
2021-03-31
Trial end
2021-03-31
Status
Completed
Treatment
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.
Arms:
vaccinated
Size
6649
Primary endpoint
Vaccine Effectiveness
3 months
Vaccinese safety
3 months
Eligibility 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 6649, 'type': 'ACTUAL'}}
Updated at
2023-03-17
1 organization
1 product
1 indication
Product
BNT162b2Indication
COVID-19