ISRCTN98052401
已完成
未知
Studying the immunogenicity and safety of combination vaccines for COVID-19
Asian Healthcare Foundation0 个研究点目标入组 44 人2022年1月6日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- COVID-19 (SARS-CoV-2 infection)
- 发起方
- Asian Healthcare Foundation
- 入组人数
- 44
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
2022 Results article in https://www.walshmedicalmedia.com/open-access/safety-and-immunogenicity-of-mixmatch-of-vaccines-covishield-and-covaxin-a-pilot-study-110892.html (added 20/12/2022)
研究者
入排标准
入选标准
- •1\. Adult male or female human volunteer aged 18\-65 years (inclusive of both) and not vaccinated for COVID\-19/influenza, willing and able to provide written, signed and dated informed consent
- •2\. Negative immunoglobulin M (IgM) SARS\-CoV\-2 antibodies through enzyme immunoassay test result
- •3\. Negative COVID\-2019 Reverse Transcriptase\-Polymerase Chain Reaction (RT\-PCR) test result at the screening visit
- •4\. No medical history or evidence of COVID\-19
- •5\. No acute infections and/or respiratory diseases within 14 days before enrollment
- •6\. No evidence of vaccine\-induced reactions or complications after receiving immunobiological products in the past medical history
- •7\. Willing to give consent to use effective contraception methods during the study
- •8\. Negative urine pregnancy test at the screening visit (for childbearing aged women)
- •9\. Negative human immunodeficiency virus (HIV 1 \& 2\), syphilis, hepatitis B and C test results
排除标准
- •1\. Aged \<18 years of age
- •2\. Any vaccination/immunization within 30 days before enrollment
- •3\. Any treatment with steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before enrollment
- •4\. Any treatment with immunosuppressive therapy within 3 months before enrollment
- •5\. Any drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on enrollment day
- •6\. Any neoplasms in the past medical history
- •7\. Donated blood or plasma within 3 months before enrollment
- •8\. Any history or evidence of splenectomy
- •9\. Any immunodeficiency state
- •10\. Any history or evidence of anorexia or protein deficiency of any origin
结局指标
主要结局
未指定
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