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

NCT04738435 | Completed

• 1 other identifier: 3876
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Population Surveillance; COVID-19 Vaccines; adverse effects

Outcome Measures

Primary Outcomes (1)

• Incidence of events supposedly attributed to vaccines and immunizations after Sputnik V

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

health workers

You may qualify if:

• health workers who agree to receive the sputnik V vaccine

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• Ministerio de Salud de Ciudad Autónoma de Buenos Aires: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

Location

Related Publications (8)

• Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

  PMID: 33301246 RESULT

• Di Pasquale A, Bonanni P, Garcon N, Stanberry LR, El-Hodhod M, Tavares Da Silva F. Vaccine safety evaluation: Practical aspects in assessing benefits and risks. Vaccine. 2016 Dec 20;34(52):6672-6680. doi: 10.1016/j.vaccine.2016.10.039. Epub 2016 Nov 8.

  PMID: 27836435 RESULT

• Herve C, Laupeze B, Del Giudice G, Didierlaurent AM, Tavares Da Silva F. The how's and what's of vaccine reactogenicity. NPJ Vaccines. 2019 Sep 24;4:39. doi: 10.1038/s41541-019-0132-6. eCollection 2019.

  PMID: 31583123 RESULT

• Virtanen M, Peltola H, Paunio M, Heinonen OP. Day-to-day reactogenicity and the healthy vaccinee effect of measles-mumps-rubella vaccination. Pediatrics. 2000 Nov;106(5):E62. doi: 10.1542/peds.106.5.e62.

  PMID: 11061799 RESULT

• Mitchell TC, Casella CR. No pain no gain? Adjuvant effects of alum and monophosphoryl lipid A in pertussis and HPV vaccines. Curr Opin Immunol. 2017 Aug;47:17-25. doi: 10.1016/j.coi.2017.06.009. Epub 2017 Jul 17.

  PMID: 28728074 RESULT

• Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, Berghmans PJ, Kimmel M, Van Damme P, de Hoon J, Smith W, Stephenson KE, De Rosa SC, Cohen KW, McElrath MJ, Cormier E, Scheper G, Barouch DH, Hendriks J, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021 May 13;384(19):1824-1835. doi: 10.1056/NEJMoa2034201. Epub 2021 Jan 13.

  PMID: 33440088 RESULT

• Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott A, Flach B, Doria-Rose NA, Corbett KS, Morabito KM, O'Dell S, Schmidt SD, Swanson PA 2nd, Padilla M, Mascola JR, Neuzil KM, Bennett H, Sun W, Peters E, Makowski M, Albert J, Cross K, Buchanan W, Pikaart-Tautges R, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. An mRNA Vaccine against SARS-CoV-2 - Preliminary Report. N Engl J Med. 2020 Nov 12;383(20):1920-1931. doi: 10.1056/NEJMoa2022483. Epub 2020 Jul 14.

  PMID: 32663912 RESULT

• 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, Torok 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.

  PMID: 33306989 RESULT

Related Links

• World Health Organization
• Technical report on the regulatory profile on authorization for the use of Sputnik V vaccine within the framework of the Law 27.573 National Administration of Drugs, Food and Medical Technology. Argentina
• Argentine Ministry of Health
• Strategic Plan for vaccination against COVID-19 in Argentina
• Online help Integrated Argentine Health Information System
• Argentine citizen digital profile to manage procedures and receive personalized information
• Epidemiological approach to risk in health care. University of San Carlos of Guatemala. Faculty of Medical Sciences
• National Administration of Drugs, Food and Medical Technology. Argentina

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vanina pagotto, Msc

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Hernan Michelangelo, MD

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vanina Pagotto

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 4, 2021
• Study Start: January 5, 2021
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

AR (1)