ISRCTN79815558进行中（未招募）3 期
A randomized, observer-blind, controlled, superiority study to compare the immunogenicity against COVID-19 of the VLA2001 vaccine and the AZD1222 vaccine in adults
Valneva (Austria)0 个研究点目标入组 4,000 人开始时间: 2021年4月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,000
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
- 性别
- All
入选标准
- •1. Participants must have read, understood, and signed the informed consent form (ICF)
- •2. Participants of either gender aged 18 years and older at screening
- •3. Medically stable
- •4. Must be able to attend all visits of the study and comply with all study procedures
- •5. Women of childbearing potential (WOCBPs) must be able and willing to use at least one highly effective method of contraception for a minimum of 3 months after the last dose of study vaccine
- •6. WOCBPs must have a negative pregnancy test prior to each vaccination
排除标准
- •1. Participant is pregnant or planning to become pregnant within 3 months after study vaccine administration
- •2. History of allergy to any component of the vaccine
- •3. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever >100 °F (>37.8 °C) 48 hours before vaccination
- •4. Participant has a known or suspected defect of the immune system
- •5. Participant has a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome
- •6. Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the participant may be enrolled. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumour site
- •7. History of drug dependency or current use of drug abuse or alcohol abuse at screening
- •8. Significant blood loss (> 450 ml) or has donated one or more units of blood or plasma within 6 weeks prior to the expected day of randomization (Visit 1)
- •9. History of clinically significant bleeding disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture
- •10. Severe and uncontrolled ongoing autoimmune or inflammatory disease History of Guillain-Barre syndrome or any other demyelinating condition
- •11. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer
- •Prior/concomitant therapy:
- •12. Receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study
- •13. Receipt of medications and or vaccinations intended to prevent COVID-19
- •14. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (Visit 1)
- •15. Any member of the study team or sponsor
- •16. An immediate family member or household member of the study’s personnel
研究者
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