NCT06710925已完成3 期
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Monoclonal Antibody TNM001 Injection Against Respiratory Syncytial Virus in High-risk Infants
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Incidence of medically attended LRTI due to RT-PCR confirmed RSV
研究概览
简要总结
This study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and immunogenicity of TNM001 in high-risk infants when entering their RSV season. Approximately 201 infants will be randomized in a ratio of 2:1 to receive TNM001 or placebo. All subjects will be followed for 270 days after dosing. This study will be conducted at approximately 20 sites in China.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Weeks 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.High risk infants under 1 year of age who are entering their first RSV season at the time of screening.
- •2.Subject's legal representative(s) is(are) able to understand and comply with the requirements and procedures of the protocol,including scheduled visits and sample collection.
- •3.Subject is available to complete the follow-up period.
排除标准
- •1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization
- •2. History of RSV infection
- •3. Being hospitalized at the time of randomization
- •4. Currently receiving or expected to receive immunosuppressive therapy during the study period.
- •5. Renal impairment or hepatic dysfunction
- •6. Nervous system disease or neuromuscular disease
- •7. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
- •8. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
- •9.Receipt of RSV vaccine or mAb
- •10.Receiving blood products before randomization
研究组 & 干预措施
TNM001
Experimental
干预措施: TNM001 (Biological)
Placebo
Placebo Comparator
干预措施: placebo (Biological)
结局指标
主要结局
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
时间窗: 150 days post dose
次要结局
未报告次要终点
研究者
研究点 (2)
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