jRCT2031220493进行中（未招募）不适用
A Phase 1/2/3, Randomized, Observer-Blind Study of S-268019 in Participants Aged 5 to 11 Years (Part 2)(COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 主要终点
- GMT and seroconversion rate of SARS-CoV-2 neutralizing antibody titer
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
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 5age 0month 0week old over 至 12age 0month 0week old not（—）
- 性别
- All
入选标准
- •Participant aged 5 to 11 years, at the time of signing the informed consent form (ICF).
- •Male and female.
- •Capable of giving signed ICF from parent(s) or legal guardian of participant and obtained assent from participant, as stated in the protocol which includes compliance with the requirements and restrictions listed in the ICF/informed assent form (IA) and in the protocol.
排除标准
- •"Tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening.
- •Determined in the interview prior to the study intervention to have a history of SARS-CoV-2 infection.
- •Receiving anticoagulation therapy, or having thrombocytopenia or coagulopathy.
- •Current history of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation.
- •Immunosuppressed (immunocompromised, having acquired immunodeficiency syndrome [AIDS], having received steroids and having received systemic immunosuppressants within 6 months prior to the first dose of study intervention, being treated for malignant tumors, being on other immunosuppressive therapy).
- •Individuals considered to have hypersensitivity to any of the study interventions or components thereof, or drug or other allergy that, in the opinion of the investigator or subinvestigator, contraindicates participation in the study (except for pollinosis and atopic dermatitis).
- •Participant has a contraindication to intramuscular(IM) injections or blood draws.
- •Participant weighing under 10 kg."
结局指标
主要结局
GMT and seroconversion rate of SARS-CoV-2 neutralizing antibody titer
时间窗: Day 57
GMT and seroconversion rate of SARS-CoV-2 neutralizing antibody titer on Day 57
GMT and seroresponse rate of SARS-CoV-2 neutralizing antibody titer
时间窗: Day 239
GMT and seroresponse rate of SARS-CoV-2 neutralizing antibody titer on Day 239
次要结局
未报告次要终点
研究者
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