A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲb Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Booster Dose in Adults Aged 18 Years and Above
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Efficacy index -COVID-19 incidence
研究概览
简要总结
This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research & Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 18 years and above.
详细描述
This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research & Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 18 years and above.A total of 13,800 participants aged 18 years and above, who have received 2 doses CoronaVac® in an interval between 21-56 days will be enrolled.Participants will be enrolled and randomly assigned into 3 groups at a ratio of 1:1:1 to receive a booster dose of medium-dose or high-dose COVID-19 Vaccine or placebo 5-8 months after their second dose.Efficacy assessments will include the surveillance for COVID-19-like symptoms, the laboratory confirmation of SARS-CoV-2 infection by RT-PCR, and recording of COVID-19-related hospitalizations.All participants will be monitored for immediate reactions (within 30 minutes) after the booster dose vaccination, adverse events of special interest (AESIs) and serious adverse events (SAEs) for 6 months after booster dose inoculation. In addition,participants in reactogenicity subgroup will be monitored for local and systemic solicited adverse events (AEs) within 7 days and the unsolicited AEs within 28 days.Immunogenicity assessments will be determined by neutralizing and anti-SARS-CoV-2 S-protein antibodies in subgroup participants. The participants in the immunogenicity subgroup will be in the reactogenicity subgroup as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18 years and above, who have received 2 prior doses of CoronaVac® with an interval between those doses of 21-56 days, with the second dose given 5-8 months prior to the day of vaccination in the present study;
- •The participants are able to understand and sign the informed consent voluntarily;
- •Female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding;
- •Must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.
排除标准
- •History of confirmed infection of SARS-CoV-2 prior to randomization;
- •Any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
- •Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- •Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
- •Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
- •Receipt of blood/plasma products or immunoglobulins in the past 3 months before vaccination;
- •Participation in other studies involving study intervention within 30 days prior to vaccination;
- •Receipt of attenuated live vaccines in the past 14 days prior to vaccination;
- •Receipt of inactivated or subunit vaccines in the past 7 days prior to vaccination;
- •Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc);
- •Acute febrile illness with axillary temperature >37.5°C on the day of vaccination; enrollment could be considered if the fever is absent for 72 hours prior to vaccination;
- •According to the investigator's judgment, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk to the participant due to participation in the study
结局指标
主要结局
Efficacy index -COVID-19 incidence
时间窗: 6 months after booster dose
COVID-19 incidence per 100 person-years of follow-up based on laboratory confirmed cases in participants aged 18 years and above, 6 months after booster dose
次要结局
- Efficacy index -Confirmed hospitalized/severe/death incidence of COVID-19(6 months after booster dose)
- Safety index-AEs(Up to 28 days after booster dose)
- Safety index-Local reactions(Up to 7 days after booster dose)
- Safety index-Systemic events(Up to 7 days after booster dose)
- Safety index-SAEs(Up to 6 months after booster dose)