jRCT2031220224已完成不适用
A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Compare the Immunogenicity of the fourth dose of S-268019 to the COMIRNATY intramuscular injection in Adults over 60 years of ages (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- SARS-CoV-2 neutralizing antibody (NAb) 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
- 60age 0month 0week old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant aged 60 or over 60 years, at the time of signing the informed consent form (ICF).
- •Participants with at least 5 months and not greater than 8 months after completion of the third vaccination with an approved SARS-CoV-2 vaccine, COMIRNATY.
- •Male and female
- •Capable of giving signed ICF from participant, as stated in the protocol which includes compliance with the requirements and restrictions listed in the ICF 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.
结局指标
主要结局
SARS-CoV-2 neutralizing antibody (NAb) titer
时间窗: 28 days following the fourth vaccination
SARS-CoV-2 neutralizing antibody (NAb) titer at 28 days following the fourth vaccination
Incidence of adverse events
The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited AEs, medically-attended AEs (MAAEs), or AEs of special interest (AESIs)
Vital signs
Vital signs
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
不适用
A Booster Study of S-268019 in Participants Aged 5 to 11 Years (COVID-19)jRCT2031220530Shionogi & Co., Ltd.100
进行中（未招募）
不适用
A Phase 1/2/3 Study of S-268019 in Participants Aged 5 to 11 Years (Part 2)(COVID-19)jRCT2031220493Shionogi & Co., Ltd.150
已完成
1 期
A Phase 1 study of S-217622COVID-19JPRN-jRCT2031210202agata Tsutae201
招募中
1 期
A Phase 1 Study of S-892216 (COVID-19)COVID-19JPRN-jRCT2031230082Gomez Juan Carlos248
进行中（未招募）
1 期
A Phase 1/2 study of S-268019 (COVID-19)JPRN-jRCT2031210269agata Tsutae60