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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Karabaglar
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Izmir, Karabaglar, Pavo
- University of Health Sciences Izmir Bozyaka Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Transversal
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Adverse events detection
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Selma Tosun, Prof., Izmir Bozyaka Education and Research Hospital
- Silla de estudio: Hulya Ozkan Ozdemir, MD, Izmir Bozyaka Education and Research Hospital
- Silla de estudio: Esin Erdogan, Assoc. Prof., University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- Silla de estudio: Seniz Akcay, Assoc. Prof., University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- Silla de estudio: Murat Aysin, Assis. Prof., Izmir Katip Celebi University, Faculty of Medicine
- Silla de estudio: Neslihan Eskut, MD, University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- Silla de estudio: Pinar Ortan, Prof., University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- Silla de estudio: Burak Eskut, MD, University of Izmir Katip Celebi, Ataturk Education and Research Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 24.02.2021-29
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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