jRCT2011220011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 1)(COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 主要终点
- incidence of adverse events (AEs)
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 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.
- •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
incidence of adverse events (AEs)
The incidence of adverse events (AEs)
incidence of adverse reactions
The incidence of adverse reactions
incidence of serious AEs (SAEs)
The incidence of serious AEs (SAEs)
incidence of solicited AEs
The incidence of solicited AEs
incidence of medically-attended AEs (MAAEs)
The incidence of medically-attended AEs (MAAEs)
incidence of AEs of special interest (AESIs)
The incidence of AEs of special interest (AESIs)
vital signs
Vital signs
ECG
ECG
次要结局
未报告次要终点
研究者
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