An international randomised trial of candidate vaccines against COVID-19

World Health Organization0 个研究点目标入组 80,000 人开始时间: 2021年10月8日最近更新: 2024年8月5日

适应症

试验速览

暂无简介。

•1. Male or female participants between the ages of 16 and above at randomization
•2. Living in the area and planning to reside in the area for at least 6 months
•3. Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent as described in SOP-03
•4. Healthy participants who are determined by the clinical judgment of the investigator to be eligible for inclusion in the study
•5. Participants who are willing and able to comply with all scheduled visits, vaccination plans, laboratory tests (if randomised and consent given, lifestyle considerations, and other study procedures

•1. Previous laboratory-confirmed diagnosis of COVID 19.
•2. Previous vaccination with any COVID-19 vaccine.
•3. Receipt of medications intended to prevent COVID 19.
•4. Participation in other studies involving a study intervention within 28 days prior to study entry and/or during study participation.
•5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
•6. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
•7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
•8. Women who are pregnant or breastfeeding will be informed that there is no data on the safety of these vaccines among these groups and will be given the opportunity to decide if they are willing to participate in the trial.

发起方