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CompletedNCT05026879Updated Sep 2, 2021

Adverse Events Report of Inactivated COVID-19 Vaccine

An observational study in COVID-19 and Vaccine Adverse Reaction, sponsored by Bozyaka Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-02.

Sponsored by Bozyaka Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
4,040
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • COVID-19
  • Vaccine Adverse Reaction

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Keywords

  • COVID-19
  • Vaccine
  • Vaccination
  • Adverse effect
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 4,040 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Bozyaka Training and Research Hospital is the lead sponsor of 50 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The healthcare workers

Inclusion criteria

1)The HCWs vaccinated with two doses of CoronaVac.

Exclusion criteria

Exclusion Criteria:

  1. The HCWs under 18 years old
  2. The HCWs those couldn't be able to complete the questionnaire accurately.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
4,040 participants (actual)
Patient registry
No

Interventions

  • BiologicalInactivated COVID-19 vaccine (CoronaVac)

    The adverse events due to an inactivated COVID-19 vaccine.

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What researchers measure

Primary outcomes

  1. Adverse events detection

    An online questionnaire was delivered to obtain Vaccine Adverse Effects to volunteer Healthcare Workers in Turkey.

    Time frame: 20 minutes

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Study locations

1 site
  • University of Health Sciences Izmir Bozyaka Training and Research Hospital
    Izmir, Karabaglar, Turkey
08

References and documents

Publications

  • 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. PubMed 32790106 ↗
  • 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. PubMed 32376603 ↗
  • 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. PubMed 32789505 ↗
  • 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. PubMed 33165503 ↗
  • 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. PubMed 33069281 ↗
  • 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. PubMed 33217362 ↗
  • 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. PubMed 33548194 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05026879
Lead sponsor
Bozyaka Training and Research Hospital
Responsible party
Şeniz Akçay (Physical Medicine and Rehabilitation, Study Chair, Assoc. Prof., Bozyaka Training and Research Hospital) — Principal investigator
First posted
Aug 30, 2021
Start date
Feb 14, 2021
Primary completion
Feb 28, 2021
Completion
Mar 14, 2021
Last update
Sep 2, 2021

Study contacts

Selma Tosun, Prof.
principal investigator · Izmir Bozyaka Education and Research Hospital
Hulya Ozkan Ozdemir, MD
study chair · Izmir Bozyaka Education and Research Hospital
Esin Erdogan, Assoc. Prof.
study chair · University of Health Sciences, Izmir Bozyaka Education and Research Hospital
Seniz Akcay, Assoc. Prof.
study chair · University of Health Sciences, Izmir Bozyaka Education and Research Hospital
Murat Aysin, Assis. Prof.
study chair · Izmir Katip Celebi University, Faculty of Medicine
Neslihan Eskut, MD
study chair · University of Health Sciences, Izmir Bozyaka Education and Research Hospital
Pinar Ortan, Prof.
study chair · University of Health Sciences, Izmir Bozyaka Education and Research Hospital
Burak Eskut, MD
study chair · University of Izmir Katip Celebi, Ataturk Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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