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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Karabaglar
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Izmir、Karabaglar、火鸡
- University of Health Sciences Izmir Bozyaka Training and Research Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：横截面
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Adverse events detection
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Selma Tosun, Prof.、Izmir Bozyaka Education and Research Hospital
- 学习椅：Hulya Ozkan Ozdemir, MD、Izmir Bozyaka Education and Research Hospital
- 学习椅：Esin Erdogan, Assoc. Prof.、University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- 学习椅：Seniz Akcay, Assoc. Prof.、University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- 学习椅：Murat Aysin, Assis. Prof.、Izmir Katip Celebi University, Faculty of Medicine
- 学习椅：Neslihan Eskut, MD、University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- 学习椅：Pinar Ortan, Prof.、University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- 学习椅：Burak Eskut, MD、University of Izmir Katip Celebi, Ataturk Education and Research Hospital
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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