A Randomized, Double-blind, Placebo-controlled and Parallel Group Adaptive Phase 2b/3 Trial to Evaluate the Efficacy and Safety of TNM001 Injection for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Under One Year of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,282
- 试验地点
- 39
- 主要终点
- Incidence of medically attended LRTI due to RT-PCR confirmed RSV
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.
详细描述
This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants [gestational age (GA)﹤35 weeks 0 day] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 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 Years 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Early and mid-term preterm infants (<35 weeks 0 day GA) and late preterm infants or full-term infants (≥35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD)，who are entering their first RSV season at the time of screening.
排除标准
- •1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization
- •2. History of RSV infection or active RSV infection prior to, or at the time of, randomization
- •3. Drug medication prior to randomization or expected to be treated by medicines during the study period.
- •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. Prior history of a suspected or actual acute life-threatening event
- •8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
- •9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
- •10.Receipt of RSV vaccine or mAb
研究组 & 干预措施
TNM001
干预措施: TNM001 (Biological)
Placebo
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
- Change in heart rate (beats per minute)(240 days post dose)
- Incidence of hospitalization due to RT-PCR confirmed RSV LRTI(150 days post dose)
- Change in blood pressure (mmHg)(240 days post dose)
- Serum level of neutralizing antibody to RSV(240 days post dose)
- Serum concentration of single dose TNM001 at pre-specified timepoints(240 days post dose)
- Occurrence of adverse events (AEs)(240 days post dose)
- Change in respiratory rate (breaths per min)(240 days post dose)
- Positive rate of anti-drug antibody (ADA) to TNM001 in serum(240 days post dose)
- Change in body temperature (celsius)(240 days post dose)
- Number of subjects with clinical significant abnormality in physical examinations(240 days post dose)