Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina

Completed

• Conditions: COVID-19

• Registration Number: NCT04738435
• Lead Sponsor: Hospital Italiano de Buenos Aires

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.

Study Timeline

• Study Start: 2021-01-05
• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-01-31
• Study First Posted: 2021-02-04
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of events supposedly attributed to vaccines and immunizations after Sputnik V	From first doses up to 10 days	Incidence of events supposedly attributed to vaccines and immunizations after the fist and second doses of Sputnik V in in health personnel

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Caba, Argentina