Clinical trial NCT04738435: Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina
Official title: Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Population Surveillance
COVID-19 Vaccines
adverse effects
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Ministerio de Salud de Ciudad Autónoma de Buenos Aires
First posted: 2021-02-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: health workers

Brief summary: The main of the study is to describe the incidence in health personnel who present events supposedly attributed to vaccines and immunizations after having received the two components of the Sputnik V vaccine, with the information obtained thanks to the participation of health workers in actively reporting their health status.

Detailed description: The World Health Organization (WHO) recommends vaccination against coronavirus disease 19 (COVID-19) as a fundamental primary prevention tool to limit the health and economic effects of the pandemic. having effective and safe vaccines in the short term,will help to reduce the incidence of illness, hospitalizations and deaths related to COVID-19 and help to gradually restore a new normality in the functioning of our country.

On December 23, within the framework of Law 27573, the National Administration of Medicines, Food and Medical Technology submitted the report on the Sputnik V vaccine to the Ministry of Health of the Nation to advance in the Emergency Authorization.

The National Government ensures the processes to reach the standards of safety and efficacy for the entire Argentine territory, being vaccination in stages, free, voluntary and independent of the history of having suffered the disease.

For the surveillance of vaccine safety, the Strategic Plan proposes to health effectors "To develop a specific plan for intensified passive and active surveillance of vaccine safety, which allows the continuous analysis of the notifications of Events Supposedly Attributed to Vaccines and Immunizations.

The Ministry of Health of Buenos Aires City articulated the public and private effectors for the epidemiological follow-up of the personnel vaccinated with the first vaccines in relation to the frequency of Events Supposedly Attributed to Vaccines and Immunizations.

The main of the study is to describe the incidence in health personnel who present events supposedly attributed to vaccines and immunizations after having received the two components of the Sputnik V vaccine, with the information obtained thanks to the participation of health workers in actively reporting their health status.

Eligibility criteria: Inclusion Criteria:

* health workers who agree to receive the sputnik V vaccine

Exclusion Criteria:

* health workers who have a contraindication to receive the sputnik V vaccine

Primary outcomes:
measure: Incidence of events supposedly attributed to vaccines and immunizations after Sputnik V
timeFrame: From first doses up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Caba
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Vanina pagotto, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Italiano de Buenos Aires
name: Silvana Figar, Msc
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Mercedes Soriano
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Analia Ferloni, MD
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Valeria Aliperti, Msc
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Morena Diaz
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Nahuel Braguisnky
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Maria Isabel González
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Maria Ines Staneloni, MD
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Valeria Asprea, MD
role: STUDY_CHAIR
affiliation: Ministry of Health of the Government of the City of Buenos Aires
name: Paula Zingoni, MD
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Hernan Michelangelo, MD
role: STUDY_DIRECTOR
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