Immunogenicity, Efficacy and Safety of Inhaled (IH) Viral Vectored Vaccine (Convidecia, CanSino) as Second Booster Dose Against Emerging Variants of Concern (VOC) of SARS-CoV-2 to Prevent Breakthrough Infections. A Randomized Observer-blind Controlled Trial.

CanSino Biologics Inc.2 个研究点分布在 1 个国家目标入组 540 人开始时间: 2022年9月20日最近更新: 2023年9月8日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: CanSino Biologics Inc.
入组人数: 540
试验地点: 2
主要终点: Level of serum Anti-Nucleocapsid IgG by ELISA.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This will be a randomized single-blind controlled trial to determine the immunogenicity, efficacy and safety of IH Convidecia (CanSino), as a second booster vaccination against Omicron and other emerging VOCs to prevent breakthrough infections among people with a sub-optimal immune response to the first booster dose.

These subjects will be randomized in a ratio of 1:1 to receive a second booster dose of IH Convidecia vaccine (treatment arm), or a second booster dose of mRNA vaccine BNT162b2 (Pfizer).

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: Single (Investigator)

盲法说明

Observer-blind clinical trial

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

•Participant is willing and able to give written informed consent for participation in the study.
•Male or Female, aged 18 years or above and in good health as determined by study clinician. Participants may have well controlled or mild-moderate comorbidity.
•Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation.
•In the Investigator's opinion, participant is able and willing to comply with all trial requirements.
•At least 16 weeks after first booster dose of vaccination.

排除标准

•Confirmed cases, suspected cases or asymptomatic cases of COVID-
•Self-reported history of SARS and MERS infection.
•Receipt of live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination.
•Receipt of any SARS-COV-2 vaccine after first dose of booster vaccination.
•Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
•Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
•History of allergic disease or reactions likely to be exacerbated by any component of study vaccines.
•Any history of anaphylaxis.
•Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or continuous use of anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban), or prior history of significant bleeding or bruising following IM injections or venipuncture.
•Suspected or known current alcohol or drug dependency.
•Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
•Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed).
•Participant with life expectancy of less than 6 months.