Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina (COVID-19)

August 24, 2021 updated by: VANINA LAURA PAGOTTO, Hospital Italiano de Buenos Aires
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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Caba
      • Buenos Aires, Caba, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

health workers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of events supposedly attributed to vaccines and immunizations after Sputnik V
Time Frame: 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
From first doses up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: vanina Pagotto, MSC, Hospital Italiano de Buenos Aires
  • Study Chair: Silvana Figar, MSC, Hospital Italiano de Buenos Aires
  • Study Chair: Mercedes Soriano, Hospital Italiano de Buenos Aires
  • Study Chair: Analia Ferloni, MD, Hospital Italiano de Buenos Aires
  • Study Chair: Valeria Aliperti, Msc, Hospital Italiano de Buenos Aires
  • Study Chair: Morena Diaz, Hospital Italiano de Buenos Aires
  • Study Chair: Nahuel Braguisnky, Hospital Italiano de Buenos Aires
  • Study Chair: Maria Isabel González, Hospital Italiano de Buenos Aires
  • Study Chair: Maria Ines Staneloni, MD, Hospital Italiano de Buenos Aires
  • Study Chair: Valeria Asprea, MD, Hospital Italiano de Buenos Aires
  • Study Chair: Paula Zingoni, MD, Ministry of Health of the Government of the City of Buenos Aires
  • Study Director: Hernan Michelangelo, MD, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2021

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

January 31, 2021

First Submitted That Met QC Criteria

January 31, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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