jRCT2071220080已完成不适用
A randomized, multicenter, phase 3, observer-blind, active-controlled comparative study to evaluate the safety and immunogenicity of a booster shot of ARCT-154 (a self-amplifying mRNA COVID-19 vaccine) in healthy subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 780
- 主要终点
- geometric mean of neutralizing antibodies against SARS-CoV-2 (Wuhan strain)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Individuals are male, female, or transgender participant >= 18 years of age at Screening.
- •Participant must freely provide documented informed consent prior to study procedures being performed.
- •Individuals must have been previously vaccinated with mRNA vaccine as follows:
- •Received 3 complete doses of mRNA vaccine and the last dose received with COMIRNATY occurred >= 3 months prior to Screening
- •Receipt of these vaccines is supported by any documents and application software
- •Individuals must agree to comply with all study visits and procedures (including blood tests, nasopharyngeal swabs and/or saliva sampling, diary completion, receipt of telephone calls from the site, willingness to be available for Unscheduled Clinic Visits).
- •Individuals who are able to cooperate with contraception for 28 days prior to vaccination with investigational product and for the duration of the study.
排除标准
- •Individuals with acute medical illness or febrile illness, including oral temperature > 37.5 degree Celcius within 1 day prior to Screening. These individuals may be offered the opportunity to enter the study after fever and illness has stabilized. Participants with suspected or confirmed COVID-19 should be excluded and referred for medical care. Rescreening will be permitted for individuals who presented with suspected COVID-19 if another cause is confirmed.
- •Individuals with a positive SARS-CoV-2 rapid antigen test at Screening (RT-PCR test may be performed according to institutional policy in addition to rapid antigen testing but will not be considered a screening requirement and should not delay vaccine administration).
- •Individuals with a history of COVID-19 or virologically confirmed SARS-CoV-2 infection within the past 4 months or history of COVID-19 with ongoing sequelae.
- •Individuals with a demonstrated inability to comply with the study procedures.
- •Individuals with any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.
结局指标
主要结局
geometric mean of neutralizing antibodies against SARS-CoV-2 (Wuhan strain)
时间窗: Day 29
To verify the non-inferiority of the geometric mean of neutralizing antibodies against SARS-CoV-2 (Wuhan strain) to COMIRNATY
Seroresponse rate (SRR) neutralizing antibody response rate to SARS-CoV-2 (Wuhan strain)
时间窗: Day 29
Validate that the Seroresponse rate (SRR) neutralizing antibody response rate to SARS-CoV-2 (Wuhan strain) is non-inferior to COMIRNATY
次要结局
未报告次要终点
研究者
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