Adverse Events Report of Inactivated COVID-19 Vaccine
Adverse Events Report of Inactivated COVID-19 Vaccine From 4040 Healthcare Workers
Numerous vaccination studies are conducted to protect against COVID-19 infection, and preclinical and clinical studies are still ongoing worldwide. During this extraordinary period, the necessity to perform COVID-19 vaccine studies and immunization programs together has emerged. Many manufacturing companies have started mass production of vaccines accepting the risk of failure of vaccines during trials. Vaccine Adverse Effects (VAEs) need to be documented quickly. We aimed to determine the VAEs and to compare the frequency of VAEs between groups according to socio-demographic characteristics after the inactivated vaccine (Corona Vac®) was administered to healthcare workers (HCWs) in Turkey.
In this study, an online questionnaire was delivered to volunteer healthcare workers across the whole country. Sociodemographic characteristics, medical history, history of COVID-19 infection, and VAEs occurring after the first and second doses of inactivated vaccine were evaluated.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A new coronavirus, severe acute respiratory syncytial coronavirus 2 (SARS-CoV-2) first appeared in China at the end of 2019 and attracted attention with clusters of pneumonia-like cases, which were later defined as coronavirus disease 2019 (COVID-19). Vaccine development is usually achieved over decades and therefore it is unprecedented to have access to such a large number of approved vaccines for COVID-19. In this process, great efforts were made by many organizations to cope with this pandemic that affected the whole world.
COVID-19 vaccines with different features in the form of vector-mediated, messenger RNA (mRNA) or inactivated vaccines are being produced worldwide. CoronaVac® is an inactivated vaccine against severe acute respiratory syncytial coronavirus 2 (SARS-CoV-2) developed by Sinovac Biotech, China which was approved by World Health Organization (WHO) in June 2021.
Vaccine Adverse Effect (VAE) is defined as "any adverse medical event that occurs after vaccination, which is thought to be due to a vaccine.
The primary endpoint of our study was to evaluate the VAEs reported after the first dose and the second doses following the inactivated vaccine (CoronaVac®), which was administered to HCWs in our country as a dose of 3 µg twice, 28 days apart. The secondary endpoint was the comparison of the frequency of VAE development between groups according to socio-demographic characteristics.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Karabaglar
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Izmir, Karabaglar, Kalkun
- University of Health Sciences Izmir Bozyaka Training and Research Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
1)The HCWs vaccinated with two doses of CoronaVac.
Exclusion Criteria:
- The HCWs under 18 years old
- The HCWs those couldn't be able to complete the questionnaire accurately.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tværsnit
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Adverse events detection
Tidsramme: 20 minutes
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An online questionnaire was delivered to obtain Vaccine Adverse Effects to volunteer Healthcare Workers in Turkey.
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20 minutes
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Selma Tosun, Prof., Izmir Bozyaka Education and Research Hospital
- Studiestol: Hulya Ozkan Ozdemir, MD, Izmir Bozyaka Education and Research Hospital
- Studiestol: Esin Erdogan, Assoc. Prof., University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- Studiestol: Seniz Akcay, Assoc. Prof., University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- Studiestol: Murat Aysin, Assis. Prof., Izmir Katip Celebi University, Faculty of Medicine
- Studiestol: Neslihan Eskut, MD, University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- Studiestol: Pinar Ortan, Prof., University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- Studiestol: Burak Eskut, MD, University of Izmir Katip Celebi, Ataturk Education and Research Hospital
Publikationer og nyttige links
Generelle publikationer
- Li J, Huang DQ, Zou B, Yang H, Hui WZ, Rui F, Yee NTS, Liu C, Nerurkar SN, Kai JCY, Teng MLP, Li X, Zeng H, Borghi JA, Henry L, Cheung R, Nguyen MH. Epidemiology of COVID-19: A systematic review and meta-analysis of clinical characteristics, risk factors, and outcomes. J Med Virol. 2021 Mar;93(3):1449-1458. doi: 10.1002/jmv.26424. Epub 2020 Aug 25.
- Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, Li Y, Zhu L, Wang N, Lv Z, Gao H, Ge X, Kan B, Hu Y, Liu J, Cai F, Jiang D, Yin Y, Qin C, Li J, Gong X, Lou X, Shi W, Wu D, Zhang H, Zhu L, Deng W, Li Y, Lu J, Li C, Wang X, Yin W, Zhang Y, Qin C. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020 Jul 3;369(6499):77-81. doi: 10.1126/science.abc1932. Epub 2020 May 6.
- Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, Li X, Peng C, Zhang Y, Zhang W, Yang Y, Chen W, Gao X, You W, Wang X, Wang Z, Shi Z, Wang Y, Yang X, Zhang L, Huang L, Wang Q, Lu J, Yang Y, Guo J, Zhou W, Wan X, Wu C, Wang W, Huang S, Du J, Meng Z, Pan A, Yuan Z, Shen S, Guo W, Yang X. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. JAMA. 2020 Sep 8;324(10):951-960. doi: 10.1001/jama.2020.15543.
- Che Y, Liu X, Pu Y, Zhou M, Zhao Z, Jiang R, Yin Z, Xu M, Yin Q, Wang J, Pu J, Zhao H, Zhang Y, Wang L, Jiang Y, Lei J, Zheng Y, Liao Y, Long R, Yu L, Cui P, Yang H, Zhang Y, Li J, Chen W, He Z, Ma K, Hong C, Li D, Jiang G, Liu D, Xu X, Fan S, Cheng C, Zhao H, Yang J, Li Y, Zou Y, Zhu Y, Zhou Y, Guo Y, Yang T, Chen H, Xie Z, Li C, Li Q. Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in Healthy Adults. Clin Infect Dis. 2021 Dec 6;73(11):e3949-e3955. doi: 10.1093/cid/ciaa1703.
- Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, Tan W, Wu G, Xu M, Lou Z, Huang W, Xu W, Huang B, Wang H, Wang W, Zhang W, Li N, Xie Z, Ding L, You W, Zhao Y, Yang X, Liu Y, Wang Q, Huang L, Yang Y, Xu G, Luo B, Wang W, Liu P, Guo W, Yang X. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021 Jan;21(1):39-51. doi: 10.1016/S1473-3099(20)30831-8. Epub 2020 Oct 15.
- Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.
- Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, Li M, Jin H, Cui G, Chen P, Wang L, Zhao G, Ding Y, Zhao Y, Yin W. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24.02.2021-29
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med COVID-19
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PfizerAktiv, ikke rekrutterendeCOVID-19 | Coronavirus sygdom 2019 (COVID-19) | Covid-19-infektion | Vacciner mod covid-19 | SARS-CoV-2-infektion, COVID19 | COVID-19-vaccination | SARS-CoV-2-infektion, COVID-19 | COVID-19 (Coronavirus sygdom 2019) | COVID-19 SARS-CoV-2-infektionForenede Stater
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PfizerRekrutteringLuftvejssygdomme | COVID-19 | Lungebetændelse | Lungesygdomme | Coronavirussygdom 2019 | Coronavirus sygdom 2019 (COVID-19) | Covid-19-infektion | Øvre luftvejsinfektioner | Luftvejsinfektion | COVID-19 (Coronavirus sygdom 2019) | COVID-19 SARS-CoV-2-infektionBelgien
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Shanghai Public Health Clinical CenterIkke rekrutterer endnu
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Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Afsluttet
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Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RekrutteringTilstand efter COVID-19 | Efter COVID-19 | Post COVID-19 syndrom | Langt COVID-19 syndrom | Post COVID-19 tilstand (PCC)Tyskland
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University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico og andre samarbejdspartnereAfsluttetPostakutte følgesygdomme af COVID-19 | Tilstand efter COVID-19 | Langtids-COVID | Kronisk COVID-19 syndromItalien
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Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRekrutteringTræthed | Post-COVID-19 syndrom | Tilstand efter COVID-19 | Post-COVID syndrom | Lang COVID-19 | Langtids-COVID | Post-COVID tilstandCanada
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RSUP PersahabatanAfsluttetPost COVID-19 syndrom | Langt COVID-19 syndrom | Post COVID-syndrom Long CovidIndonesien
Kliniske forsøg med Inactivated COVID-19 vaccine (CoronaVac)
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Sinovac Research and Development Co., Ltd.AfsluttetCOVID-19Dominikanske republik
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Butantan InstituteAfsluttet
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Butantan InstituteSinovac Life Sciences Co., Ltd.Afsluttet
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Hospital Moinhos de VentoPfizer; Universidade Federal do Paraná; Inova MedicalAfsluttet
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Sinovac Research and Development Co., Ltd.Aktiv, ikke rekrutterende
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Hospital Moinhos de VentoPfizer; Universidade Federal do Paraná; Inova MedicalAfsluttet
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Sinovac Life Sciences Co., Ltd.Aktiv, ikke rekrutterende
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Sinovac Research and Development Co., Ltd.Afsluttet
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Sinovac Research and Development Co., Ltd.Afsluttet
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Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRekruttering