Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 7:18 AM
Study NCT ID:
NCT04738435
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2021-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2021-01-31', 'studyFirstSubmitQcDate': '2021-01-31', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of events supposedly attributed to vaccines and immunizations after Sputnik V', 'timeFrame': 'From first doses up to 10 days', 'description': 'Incidence of events supposedly attributed to vaccines and immunizations after the fist and second doses of Sputnik V in in health personnel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Population Surveillance', 'COVID-19 Vaccines', 'adverse effects'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '33301246', 'type': 'RESULT', 'citation': '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': '27836435', 'type': 'RESULT', 'citation': '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': '31583123', 'type': 'RESULT', 'citation': "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': '11061799', 'type': 'RESULT', 'citation': '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': '28728074', 'type': 'RESULT', 'citation': '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': '33440088', 'type': 'RESULT', 'citation': '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': '32663912', 'type': 'RESULT', 'citation': "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': '33306989', 'type': 'RESULT', 'citation': "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."}], 'seeAlsoLinks': [{'url': 'https://www.who.int/', 'label': 'World Health Organization'}, {'url': 'https://www.argentina.gob.ar/noticias/informe-de-la-anmat-sobre-la-vacuna-sputnik-v', 'label': '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'}, {'url': 'https://www.argentina.gob.ar/salud', 'label': 'Argentine Ministry of Health'}, {'url': 'https://www.argentina.gob.ar/coronavirus/vacunacion', 'label': 'Strategic Plan for vaccination against COVID-19 in Argentina'}, {'url': 'https://sisa.msal.gov.ar/sisadoc/docs/050203/nomivac_home.jsp', 'label': 'Online help Integrated Argentine Health Information System'}, {'url': 'https://www.argentina.gob.ar/miargentina', 'label': 'Argentine citizen digital profile to manage procedures and receive personalized information'}, {'url': 'https://saludpublicayepi.files.wordpress.com/2012/08/enfoque.pdf', 'label': 'Epidemiological approach to risk in health care. University of San Carlos of Guatemala. Faculty of Medical Sciences'}, {'url': 'https://www.argentina.gob.ar/anmat', 'label': 'National Administration of Drugs, Food and Medical Technology. Argentina'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOn 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.\n\nThe 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.\n\nFor 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'health workers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* health workers who agree to receive the sputnik V vaccine\n\nExclusion Criteria:\n\n* health workers who have a contraindication to receive the sputnik V vaccine'}, 'identificationModule': {'nctId': 'NCT04738435', 'acronym': 'COVID-19', 'briefTitle': 'Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina', 'orgStudyIdInfo': {'id': '3876'}}, 'contactsLocationsModule': {'locations': [{'zip': 'C1199ABB', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Vanina pagotto, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Silvana Figar, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Mercedes Soriano', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Analia Ferloni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Valeria Aliperti, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Morena Diaz', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Nahuel Braguisnky', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Maria Isabel González', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Maria Ines Staneloni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Valeria Asprea, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Paula Zingoni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ministry of Health of the Government of the City of Buenos Aires'}, {'name': 'Hernan Michelangelo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministerio de Salud de Ciudad Autónoma de Buenos Aires', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vanina Pagotto', 'investigatorFullName': 'VANINA LAURA PAGOTTO', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}