Adverse Events Report of Inactivated COVID-19 Vaccine
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|ClinicalTrials.gov Identifier: NCT05026879|
Recruitment Status : Completed
First Posted : August 30, 2021
Last Update Posted : September 2, 2021
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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.
|Condition or disease||Intervention/treatment|
|COVID-19 Vaccine Adverse Reaction||Biological: Inactivated COVID-19 vaccine (CoronaVac)|
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.
|Study Type :||Observational|
|Actual Enrollment :||4040 participants|
|Official Title:||Adverse Events Report of Inactivated COVID-19 Vaccine From 4040 Healthcare Workers|
|Actual Study Start Date :||February 14, 2021|
|Actual Primary Completion Date :||February 28, 2021|
|Actual Study Completion Date :||March 14, 2021|
- Biological: Inactivated COVID-19 vaccine (CoronaVac)
The adverse events due to an inactivated COVID-19 vaccine.
- Adverse events detection [ Time Frame: 20 minutes ]An online questionnaire was delivered to obtain Vaccine Adverse Effects to volunteer Healthcare Workers in Turkey.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
1)The HCWs vaccinated with two doses of CoronaVac.
- The HCWs under 18 years old
- The HCWs those couldn't be able to complete the questionnaire accurately.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05026879
|University of Health Sciences Izmir Bozyaka Training and Research Hospital|
|Izmir, Karabaglar, Turkey|
|Principal Investigator:||Selma Tosun, Prof.||Izmir Bozyaka Education and Research Hospital|
|Study Chair:||Hulya Ozkan Ozdemir, MD||Izmir Bozyaka Education and Research Hospital|
|Study Chair:||Esin Erdogan, Assoc. Prof.||University of Health Sciences, Izmir Bozyaka Education and Research Hospital|
|Study Chair:||Seniz Akcay, Assoc. Prof.||University of Health Sciences, Izmir Bozyaka Education and Research Hospital|
|Study Chair:||Murat Aysin, Assis. Prof.||Izmir Katip Celebi University, Faculty of Medicine|
|Study Chair:||Neslihan Eskut, MD||University of Health Sciences, Izmir Bozyaka Education and Research Hospital|
|Study Chair:||Pinar Ortan, Prof.||University of Health Sciences, Izmir Bozyaka Education and Research Hospital|
|Study Chair:||Burak Eskut, MD||University of Izmir Katip Celebi, Ataturk Education and Research Hospital|
|Responsible Party:||Şeniz Akçay, Physical Medicine and Rehabilitation, Study Chair, Assoc. Prof., Bozyaka Training and Research Hospital|
|Other Study ID Numbers:||
|First Posted:||August 30, 2021 Key Record Dates|
|Last Update Posted:||September 2, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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