PACTR202103845381761尚未招募3 期
A global multicenter, randomised, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older.
Chengdu WestVac Biopharm Co Ltd0 个研究点目标入组 40,000 人开始时间: 2021年3月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40,000
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1.Aged 18 years and older.
- •2.Able and willing (in the investigator’s opinion) to comply with all study requirements.
- •3.Willing to allow the investigators to discuss the volunteer’s medical history with their general practitioner/personal doctor and access all medical records which are relevant to study procedures.
- •4.Healthy adults, or stable-healthy adults who may have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- •5.For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 90 days after completion of 3 doses vaccination during the study, and have a negative pregnancy tests before each dose vaccination.
- •Note:nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for = 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status.
- •6.Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination.
- •7.Agreement to refrain from blood donation during the study.
- •8.Provide written informed consent form (ICF).
排除标准
- •1.Participation in any other COVID-19 prophylactic drug trials during the duration of the study.
- •Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible.
- •2.Positive HIV antibody testing results.
- •3.Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study.
- •Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
- •4.Planned receipt of any licensed or investigational vaccine, other than the study intervention, within 14 days before and after study vaccination
- •5.Prior receipt of an investigational or licensed COVID-19 vaccine.
- •6.Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the investigational products (IPs).
- •7.Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months. Topical steroids or short-term (course lasting =14 days) oral steroids are not an exclusion criteria.
- •8.History of allergic disease or reactions likely to be exacerbated by any component of Recombinant COVID-19 vaccine (Sf9 cells)
- •9.Any history of angioedema
- •10.Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine
- •11.Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •12.History of serious psychiatric condition likely to affect participation in the study
- •13.Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding
研究者
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