A randomised, controlled clinical trial to assess and compare the immunogenicity, safety and reactogenicity of the bivalent-Omicron BA.4/BA.5-adapted, and the original-Wuhan-Hu-1-strain-monovalent, BNT162b2 COVID-19 vaccine formulations in healthy unvaccinated East African adults.

OXFORD0 个研究点目标入组 580 人开始时间: 2023年4月8日最近更新: 2024年3月4日

适应症

试验速览

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•1) Adult (?18 years of age) males, or non-pregnant females.
•2) Able and willing to comply with trial requirements.
•3) For females only, a negative pregnancy test within 24 hours prior to administration of each of the two vaccine doses and willing to take contraception till 28 days after the second vaccine dose.
•4) Provide written informed consent.

•1)Documented history of any COVID-19 vaccination.
•2)Prior receipt of an investigational, or licensed vaccine within the last 30 days.
•3)Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the first vaccine dose.
•4)Any confirmed, or suspected immunosuppressive, or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days).
•5)History of allergic disease, or reactions that could be exacerbated by any component of study vaccine.
•6)Any history of angioedema or anaphylaxis.
•7) Any history of myocarditis and pericarditis.
•8)Pregnancy or lactation at the time of screening.
•9)Bleeding disorders, or other conditions that in the opinion of the investigator contraindicate intramuscular injection.
•10)Any other conditions that in the opinion of the investigator may jeopardise participant safety and / or interfere with study outcomes
•11)Participating, or planned participation in another concurrent interventional research study.
•12) Acute febrile, or other significant, illness that may affect the conduct of the trial as judged by the study clinician (e.g., diarrhoeal illness).

发起方

OXFORD