CTRI/2022/04/041792进行中（未招募）3 期
A Phase III, Randomized, Open label, Multicentre Clinical Study in Parallel Assignment to Evaluate Immunogenicity and Safety of a Booster Dose of Sputnik Light Vector Vaccine against COVID-19 in Adult Indian Subjects.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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
入选标准
- •Subjects will be enrolled in the study if they meet all the following criteria.
- •1. Male and female aged >= 18 years
- •2. Subject who had recieved primary vaccination (both doses completed) with either
- •a. COVAXIN (Group 1) OR
- •b. COVISHIELD (Group 2)
- •Where last dose of primary vaccination was taken 6-7 months prior to the screening visit
- •3. Subjects who are determined by medical/surgical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study
- •4. If the subject had COVID-19 after primary vaccination, that subject should have passed 3 months after being asymptomatic or RT-PCR negative
- •5. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit
- •6. Consent for using effective methods of contraception during the entire trial and 3 months after its completion
- •7. No evidence of pronounced vaccine-induced reactions or complications after receiving immunobiological products in medical history
- •8. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment
排除标准
- •Subjects will be entered into the study only if they meet none of the following criteria.
- •1. Prior receipt of any COVID-19 vaccine in less than 6 months of duration
- •2. Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements
- •3. Receipt of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days prior to enrollment
- •4. Pregnancy or breast-feeding
- •5. Tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history
- •6. History of severe allergic reaction to drug or vaccine (anaphylactic shock, or other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and randomization day
- •7. Chronic immune disease or systemic collagenosis in medical history
- •8. Subjects who received transplantation and on immunosuppressive therapy
- •9. Other immunosuppressive therapy (other than steroids) that completed less than three months prior to randomization into the study
- •10. Splenectomy in the past medical history
- •11. Subjects with oncological disease within 5 years prior to inclusion into the study
- •12. Neutropenia (absolute number of neutrophils less than <1000/mm2), agranulocytosis, severe anemia (hemoglobin < 8 g/l)
- •13. Significant loss of blood, Immunodeficiency in the medical history within 6 months before the enrolment
- •14. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C
- •15. Acute Kidney injury or dialysis
- •16. Anorexia or Malnutrition
- •17. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration
- •18. Alcohol or Drug addiction in medical history
- •19. Participation in other interventional clinical trial within the previous 90 days prior to enrolment and over duration of the trial
- •20. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
研究者
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