CTRI/2021/08/035648
尚未招募
4 期
Comparison of reactogenicity and immunogenicity of heterologous prime-boost and heterologous boost of ChAdOx1 nCoV-19 (Covishield), BBV 152 (Covaxin), and other COVID vaccines with homologous administration of Covishield and Covaxin - MnM study
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Christian Medical College
- 状态
- 尚未招募
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Males and females aged 18\+ years
- •2\. No known immunodeficiency
- •3\. History of no contact with COVID\-2019 persons within at least 14 days before the enrolment (according to subjects)
- •4\. No evident vaccine\-induced reactions or complications after receiving immunobiological products in the medical history
- •5\. No acute infectious and/or respiratory diseases within at least 14 days before the enrolment.
排除标准
- •1\. Previous receipt of any COVID vaccine (only for those who are in the prime and boost part of the study)
- •2\. Any vaccination/immunization within 30 days before the enrolment
- •3\. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrolment
- •4\. Immunosuppressors therapy finished within 3 months before the enrolment
- •5\. Pregnancy or breast\-feeding
- •6\. Acute coronary syndrome or stroke suffered less than one year before the enrolment
- •7\. Tuberculosis, chronic systemic infections
- •8\. Drug allergy â?? history of anaphylaxis, hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day
- •9\. Subjects who are on drugs that could have potential drug interactions with the vaccines:
- •A.drugs for multiple sclerosis (dimethyl fumarate, fingolimod, ozanimod, etc.),
结局指标
主要结局
未指定
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