CTRI/2021/10/037066已完成2 期
A Prospective, Randomised, Double-blind, Placebo controlled, Phase-II by III Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of CORBEVAX Vaccine in Children and Adolescents. - None
Biological ELimited0 个研究点目标入组 624 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 624
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. Ability to provide written informed consent (by the parents or legally acceptable/authorized representative (LAR) and assent by the children aged between =7 to <18 years.
- •2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol.
- •3. Participants of either gender of age between <18years to =5 (Participant should be <18 years at the time of Screening of the study).
- •4. Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment.
- •5. Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital sign defined as body temperature <100.4ºF prior to enrolment].
- •6. Agrees not to participate in another clinical trial at any time during the total study period.
- •7. Agrees to remain in the town where the study centre is located, for the entire duration of the study.
- •8. Willing to allow storage and future use of collected biological samples for future research in an anonymised form.
排除标准
- •1. History of vaccination with any investigational vaccine against COVID-19 disease;
- •2. Seropositive to IgG antibodies against SARS CoV-2
- •3. Living in the same household of any COVID-19 positive person;
- •4. Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment;
- •5. 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);
- •6. Current or planned participation in prophylactic drug trials for the duration of the study.
- •7. Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment.;
- •8. Body temperature of =100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination;
- •9. History of severe psychiatric conditions likely to affect participation in the study;
- •10. History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
- •11. History of allergic disease or reactions likely to be exacerbated by any component of the Biological E’s CORBEVAX vaccine formulations;
- •12. Chronic respiratory disease, including asthma;
- •13. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness;
- •14. Any other serious chronic illness requiring hospital specialist supervision;
- •15. 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. For corticosteroids, this will mean prednisolone =0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed;
- •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. Individuals who are part of the study team or close family members of individuals conducting the study.
- •19. Anaphylactic reaction following administration of the investigational vaccine.
研究者
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