A Prospective, Single-blind, Randomized, Active-controlled Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Biological E’s CORBEVAX Vaccine for Protection Against COVID-19 Disease When Administered to RT-PCR Negative Adult Subjects. - None

Biological E Limited0 个研究点目标入组 2,140 人开始时间: 待定最近更新: 2024年7月22日

试验速览

阶段: 3 期
状态: 已完成
发起方: Biological E Limited
入组人数: 2,140

研究概览入排标准研究者记录与标识符相似试验

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. Subject is seronegative to anti-SARS-CoV-2 IgG antibody prior to randomisation either into Group-1 and Group-2.
•2. Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment in all groups.
•3. Male or female subject between = 18 to 80 years of age.
•4. Subject is willing to provide a written informed consent for voluntary participation in the study.
•5. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol.
•6. Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment.
•7. Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination.
•8. Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study.
•9. Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration.
•10. Subject agrees not to participate in another clinical trial at any time during the total study period.
•11. Subject agrees to refrain from blood donation during the course of the study.
•12. Subject agrees to remain in the town where the study centre is located, for the entire duration of the study.

排除标准

•1. History of vaccination with any investigational or approved vaccine against COVID-19 disease.
•2. Subject living in the same household as that of any active COVID-19 positive individual.
•3. History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines);
•4. Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator.
•5. Subjects with Body temperature of =100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination.
•6. Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study.
•7. Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study:
•8. severe psychiatric conditions;
•9. any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
•10. allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE SARS-CoV-2 COVID-19 vaccine);
•11. neurological illness, and any other serious chronic illness requiring hospital specialist supervision.
•12. Subjects requiring chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products.
•13. For corticosteroids, this will mean prednisone =0.5 mg/kg/day, or equivalent.
•14. Inhaled and topical steroids are allowed.
•15. Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data.
•16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•17. Any medical condition that in the judgment of the investigator would make study participation unsafe.
•18. Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment.
•19. Current or planned participation in prophylactic drug trials for the duration of the study.
•20. Individuals who are part of the study team or close family members of individuals conducting the study.

研究者

发起方

Biological E Limited

相似试验

进行中（未招募）

不适用

A prospective, randomized, double-blind, active controlled, parallel group, multi-center trial to assess the efficacy and safety of mycophenolate mofetil MMF in inducing response and maintaining remission in subjects with lupus nephritisupus nephritis LNMedDRA version: 9.1Level: LLTClassification code 10025140Term: Lupus nephritis

EUCTR2004-004917-41-ITASPREVA PHARMACEUTICALS CORPORATIO358

进行中（未招募）

不适用

A prospective, randomized, double-blind, active controlled, parallel group, multi-center trial to assess the efficacy and safety of mycophenolate mofetil (MMF) in inducing response and maintaining remission in subjects with lupus nephritis. - Aspreva Lupus Management Study (ALMS)

EUCTR2004-004917-41-PTAspreva Pharmaceuticals Corporation as part of the Roche-Aspreva Collaboration Agreement358

进行中（未招募）

不适用

EUCTR2004-004917-41-HUAspreva Pharmaceuticals Corporation as part of the Roche-Aspreva Collaboration Agreement358

已完成

3 期

A Clinical Study to Evaluate the Efficacy and Safety of PLENMOXI (Moxifloxacin Intravenous Infusion 0.4% w/v) in the Treatment of Bacterial Infections.â??

CTRI/2017/11/010388OSOURCE PHARMA LTD50

已完成

3 期

Clinical study to evaluate efficacy and safety ofDydrogesterone 20 mg Tablets Compared toDydrogesterone 10 mg tablet in the Management Of Endometriosis

CTRI/2024/04/065082Ms Abbott India Limited230