Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
Ministerio de Salud de Ciudad Autónoma de Buenos Aires
Information provided by (Responsible Party):
VANINA LAURA PAGOTTO, 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.

Condition or disease
COVID-19

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
health workers
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Vanina Pagotto, Msc (54 11) 4959-0200 ext 5398 vanina.pagotto@hospitalItaliano.org.ar

Locations
Layout table for location information
Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Caba, Argentina, C1199ABB
Contact: Vanina L Pagotto, MD MG    0054 49590200 ext 5398    vanina.pagotto@hospitalitaliano.or.ar   
Contact: Silvana Figar, MD MG    0054 49590200 ext 5398    silvana.figar@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Ministerio de Salud de Ciudad Autónoma de Buenos Aires
Investigators
Layout table for investigator information
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
Additional Information:
Publications of Results:
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum in: Lancet. 2021 Jan 9;397(10269):98.

Layout table for additonal information
Responsible Party: VANINA LAURA PAGOTTO, Vanina Pagotto, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT04738435    
Other Study ID Numbers: 3876
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VANINA LAURA PAGOTTO, Hospital Italiano de Buenos Aires:
Population Surveillance
COVID-19 Vaccines
adverse effects