ISRCTN26285740已完成未知
A randomized controlled trial to study the immunogenicity and safety of Curvic® in a vaccinated population for COVID-19
Shreepad Shree Vallabh SSV Phytopharmaceuticals0 个研究点目标入组 50 人开始时间: 2022年4月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult male or female human volunteer of age 18-65 years (inclusive)
- •2. Eligible for vaccination for COVID-19
- •3. Willing and able to provide written, signed and dated informed consent
- •4. Had no medical history or evidence of COVID-2019
- •5. Had no acute infections and/or respiratory diseases within 14 days before enrollment.
- •6. Had 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. Have a negative urine pregnancy test at the screening visit (for child-bearing aged women)
- •9. Have negative human immunodeficiency virus (HIV 1 & 2), syphilis, hepatitis B and C test results
排除标准
- •1. Aged <18 years and >65 years
- •2. Any vaccination/immunization within 30 days before the enrollment
- •3. Any treatment with steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before the enrollment
- •4. Any treatment with immunosuppressive therapy within 3 months before the 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 the 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
- •11. Alcohol or drug addiction in the past medical history
- •12. Participation in any other interventional clinical trial within 3 months
- •13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
- •14. Pregnancy or breast-feeding
- •15. Subjects who are tested positive for Coronavirus disease through RT-PCR SARS CoV-2 Test and positive anti-COVID antibodies within 3 months before the enrollment
研究者
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