ISRCTN26285740
Completed
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 sites50 target enrollmentApril 19, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Vaccinated for COVID-19
- Sponsor
- Shreepad Shree Vallabh SSV Phytopharmaceuticals
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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