COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older - HERALD

CureVac AG0 个研究点目标入组 36,500 人开始时间: 2020年11月19日最近更新: 2021年7月5日

适应症

试验速览

暂无简介。

•1. Male or female subjects 18 years of age or older.
•2. Be willing and able to provide written informed consent prior to initiation of any trial procedures
•3. Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
•4. Females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for = 12 consecutive months prior to screening (Day 1)} without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
•5. Females of childbearing potential: negative pregnancy test {human chorionic gonadotropin (hCG)} within 24 hours prior to each trial vaccination on Day 1 and Day 29.
•Full list of inclusion criteria is provided in the protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30000
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6500

•1. History of virologically-confirmed COVID-19 illness.
•2. For females: pregnancy or lactation.
•3. Use of any investigational or non-registered product (vaccine or drug) within 28 days preceding the administration of the first trial vaccine or planned use during the trial.
•4. Receipt of licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated or any other vaccines) prior to the administration of the first trial vaccine.
•5. Prior administration of any investigational SARS-CoV-2 vaccine or another coronavirus (SARS-CoV, MERS-CoV) vaccine or planned use during the trial.
•Full list of exclusion criteria is provided in the protocol

发起方

CureVac AG