Clinical trial NCT05026879: Adverse Events Report of Inactivated COVID-19 Vaccine
Official title: Adverse Events Report of Inactivated COVID-19 Vaccine From 4040 Healthcare Workers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Vaccine Adverse Reaction
Keywords: COVID-19
Vaccine
Vaccination
Adverse effect
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 4040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The healthcare workers

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1)The HCWs vaccinated with two doses of CoronaVac.

Exclusion Criteria:

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

Primary outcomes:
measure: Adverse events detection
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: University of Health Sciences Izmir Bozyaka Training and Research Hospital
state: Karabaglar
Study officials:
affiliation: Izmir Bozyaka Education and Research Hospital
name: Selma Tosun, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Bozyaka Education and Research Hospital
name: Hulya Ozkan Ozdemir, MD
role: STUDY_CHAIR
affiliation: University of Health Sciences, Izmir Bozyaka Education and Research Hospital
name: Esin Erdogan, Assoc. Prof.
role: STUDY_CHAIR
affiliation: University of Health Sciences, Izmir Bozyaka Education and Research Hospital
name: Seniz Akcay, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Izmir Katip Celebi University, Faculty of Medicine
name: Murat Aysin, Assis. Prof.
role: STUDY_CHAIR
affiliation: University of Health Sciences, Izmir Bozyaka Education and Research Hospital
name: Neslihan Eskut, MD
role: STUDY_CHAIR
affiliation: University of Health Sciences, Izmir Bozyaka Education and Research Hospital
name: Pinar Ortan, Prof.
role: STUDY_CHAIR
affiliation: University of Izmir Katip Celebi, Ataturk Education and Research Hospital
name: Burak Eskut, MD
role: STUDY_CHAIR
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