Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina (COVID-19)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04738435|
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : February 8, 2021
|Condition or disease|
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|
|Estimated Enrollment :||600 participants|
|Official Title:||Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina|
|Actual Study Start Date :||January 5, 2021|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
- 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
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): NCT04738435
|Contact: Vanina Pagotto, Msc||(54 11) 4959-0200 ext 5398||vanina.pagotto@hospitalItaliano.org.ar|
|Hospital Italiano de Buenos Aires||Recruiting|
|Buenos Aires, Caba, Argentina, C1199ABB|
|Contact: Vanina L Pagotto, MD MG 0054 49590200 ext 5398 email@example.com|
|Contact: Silvana Figar, MD MG 0054 49590200 ext 5398 firstname.lastname@example.org|
|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|