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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Karabaglar
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Izmir、Karabaglar、七面鳥
- University of Health Sciences Izmir Bozyaka Training and Research Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：断面図
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adverse events detection
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Selma Tosun, Prof.、Izmir Bozyaka Education and Research Hospital
- スタディチェア：Hulya Ozkan Ozdemir, MD、Izmir Bozyaka Education and Research Hospital
- スタディチェア：Esin Erdogan, Assoc. Prof.、University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- スタディチェア：Seniz Akcay, Assoc. Prof.、University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- スタディチェア：Murat Aysin, Assis. Prof.、Izmir Katip Celebi University, Faculty of Medicine
- スタディチェア：Neslihan Eskut, MD、University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- スタディチェア：Pinar Ortan, Prof.、University of Health Sciences, İzmir Bozyaka Education and Research Hospital
- スタディチェア：Burak Eskut, MD、University of Izmir Katip Celebi, Ataturk Education and Research Hospital
出版物と役立つリンク
一般刊行物
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研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 24.02.2021-29
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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