## Protocol Section
### Identification Module
**NCT ID:** NCT05026879

**Brief Title:** Adverse Events Report of Inactivated COVID-19 Vaccine

**Official Title:** Adverse Events Report of Inactivated COVID-19 Vaccine From 4040 Healthcare Workers

#### Organization Study ID Info
**ID:** 24.02.2021-29
#### Organization
**Class:** OTHER
**Full Name:** Bozyaka Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2021-03-14

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-02

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-02-28

**Type:** ACTUAL

#### Start Date
**Date:** 2021-02-14

**Type:** ACTUAL

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2021-08-30
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-27
**Study First Submit QC Date:** 2021-08-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Bozyaka Training and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Bozyaka Training and Research Hospital

**Investigator Full Name:** Şeniz Akçay

**Investigator Title:** Physical Medicine and Rehabilitation, Study Chair, Assoc. Prof.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- COVID-19

- Vaccine Adverse Reaction

**Keywords:**

- COVID-19

- Vaccine

- Vaccination

- Adverse effect

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 4040

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Inactivated COVID-19 vaccine (CoronaVac)

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Adverse events detection

**Time Frame:** 20 minutes

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The healthcare workers

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Izmir

**Country:** Turkey

**Facility:** University of Health Sciences Izmir Bozyaka Training and Research Hospital

**State:** Karabaglar

#### Overall Officials

**Official 1:**

**Affiliation:** Izmir Bozyaka Education and Research Hospital

**Name:** Selma Tosun, Prof.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Izmir Bozyaka Education and Research Hospital

**Name:** Hulya Ozkan Ozdemir, MD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** University of Health Sciences, Izmir Bozyaka Education and Research Hospital

**Name:** Esin Erdogan, Assoc. Prof.

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** University of Health Sciences, Izmir Bozyaka Education and Research Hospital

**Name:** Seniz Akcay, Assoc. Prof.

**Role:** STUDY_CHAIR

**Official 5:**

**Affiliation:** Izmir Katip Celebi University, Faculty of Medicine

**Name:** Murat Aysin, Assis. Prof.

**Role:** STUDY_CHAIR

**Official 6:**

**Affiliation:** University of Health Sciences, Izmir Bozyaka Education and Research Hospital

**Name:** Neslihan Eskut, MD

**Role:** STUDY_CHAIR

**Official 7:**

**Affiliation:** University of Health Sciences, Izmir Bozyaka Education and Research Hospital

**Name:** Pinar Ortan, Prof.

**Role:** STUDY_CHAIR

**Official 8:**

**Affiliation:** University of Izmir Katip Celebi, Ataturk Education and Research Hospital

**Name:** Burak Eskut, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 32790106

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**PMID:** 32376603

**Citation:** 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.

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**Citation:** 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.

**PMID:** 33165503

**Citation:** 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.

**PMID:** 33069281

**Citation:** 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.

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**PMID:** 33548194

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
