CTRI/2022/10/046475已完成2 期
A Prospective, Multi-centre, Open-labelled, Randomized, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability and Immunogenicity of GEMCOVAC-OM as a booster in Subjects 18 years of age and older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3,280
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
- •1. Male and female aged greater than or equal to 18 years
- •2. Subject who had received primary vaccination (both doses completed) with either
- •a. COVAXIN™ OR
- •b. COVISHIELD™
- •Wherein last dose of primary vaccination taken at least 4 months prior to the screening visit
- •3. Subject or their legally acceptable representative (LAR) should be capable and willing to give voluntary written informed consent prior to inclusion in the study
- •4. Inclusion of subjects based on clinical judgment by the investigator
- •5. Subjects who had COVID-19 infection after primary vaccination, should have been asymptomatic or RT-PCR negative for at least 3 months
- •6. Consent for using effective methods of contraception during the entire study period
- •7. No medical history of pronounced vaccine-induced reactions or complications after receiving immunobiological products
- •8. No acute infectious and/or respiratory diseases within 14 days prior to screening
- •9. Subjects able to comprehend and comply with study requirements and procedures and willing to complete subject diary
排除标准
- •1. Prior receipt of any COVID-19 vaccine in less than 4 months of duration
- •2. Pregnant or lactating mothers
- •3. Any significant illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.
- •4. History of chronic infections in immunocompromised subjects
- •5. History of chronic immune disease, Splenectomy or systemic collagenosis
- •6. Subjects with oncological disease within 5 years prior to inclusion into the study
- •7. History of the human immunodeficiency virus, syphilis, hepatitis B, or C
- •8. Acute Kidney injury or dialysis, had transplant and on immunosuppressive therapy
- •9. Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements
- •10. Receipt of steroids and/or immunoglobulins or other blood products within 30 days prior to randomization
- •11. Tattoos or scars at the injection site, which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration
- •12. Participation in other interventional clinical trial within the previous 90 days prior to randomization and over duration of the trial
- •13. 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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